Macular DegenerationMACULANCT01245387

Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration

An observational study of Macular Degeneration and Age-related Macular Degeneration, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Long-term observational study to assess the safety, efficacy and quality of life of patients with neovascular age-related macular degeneration (AMD) under Macugen treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Macular Degeneration, Age-related Macular Degeneration, Neovascular Macular Degeneration
What is being tested?: Pegaptanib
Type of treatment: Injection or infusion
How many people: 1,001 participants
Where: No sites listed yet
Study dates: Aug 2006to Dec 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with neovascular age-related macular degeneration

Who may be able to join

patients with neovascular age-related macular degeneration

Who cannot join

none

About this study

Official title: Long-Term Non-Interventional Study (AB Study) To Investigate The Efficacy And Safety Of Macugen® In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice

Long-term observational study to assess the safety, efficacy and quality of life of patients with neovascular age-related macular degeneration (AMD) under Macugen treatment.

Read the detailed description

Ophthalmologists who are experienced in doing intravitreal injections in Germany

Conditions: Macular Degeneration, Age-related Macular Degeneration, Neovascular Macular Degeneration
Being tested: Pegaptanib
Keywords: prospective, observational, Phase 4, non-interventional, open-label
Medical subject headings: Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PegaptanibDrug
Dosage recommendations for MACUGEN took place on the basis of the approved Summary of Product Characteristics (SmPC) and were adjusted solely according to medical practice. MACUGEN® is available as pre-filled syringe containing 0.3 mg MACUGEN® in 90 µL injection solution for intravitreal injection. Macugen injections were documented to reflect the routine clinical practice. Follow-up visits were only carried out and documented if they took place as part of the standard medical treatment for the respective case and were necessary for medical and/or therapeutic reasons.

Study groups in NCT01245387
Study group	Role	What they receive
Macugen		Not described Receives: Drug: Pegaptanib

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Acuity (VA)
VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study [EDTRS]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection).
Measured: Baseline, every 6 weeks up to Month 24 or early termination
Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score
Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.
Measured: Baseline, every 6 months up to Month 24 or early termination
Number of Participants With Investigator Assessments of Efficacy
Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor.
Measured: Month 24 or early termination
Lesion Size (Number of Optic Disc Areas)
Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).
Measured: Baseline, every 6 weeks up to Month 24 or early termination
Number of Participants With a Change in Activity of Neovascular Membrane at Week 6
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Measured: Week 6
Number of Participants With a Change in Activity of Neovascular Membrane at Week 12
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Measured: Week 12
Number of Participants With a Change in Activity of Neovascular Membrane at Week 18
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Measured: Week 18
Number of Participants With a Change in Activity of Neovascular Membrane at Week 24
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Measured: Week 24
Number of Participants With a Change in Activity of Neovascular Membrane at Week 30
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Measured: Week 30
Number of Participants With a Change in Activity of Neovascular Membrane at Week 36
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Measured: Week 36
Number of Participants With a Change in Activity of Neovascular Membrane at Week 42
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Measured: Week 42
Number of Participants With a Change in Activity of Neovascular Membrane at Week 48
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Measured: Week 48
Number of Participants With a Change in Activity of Neovascular Membrane at Week 54
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Measured: Week 54
Number of Participants With a Change in Activity of Neovascular Membrane at Week 60
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 12, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Measured: Week 60
Number of Participants With a Change in Activity of Neovascular Membrane at Week 66
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 13, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Measured: Week 66
Number of Participants With a Change in Activity of Neovascular Membrane at Week 72
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 14, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Measured: Week 72
Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit
Neovascular membrane activity (measured by leakage) assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. Last Visit: last available postbaseline value.
Measured: Month 24 or early termination
Number of Participants With Pigment Epithelial Detachment (PED) at Baseline
PED assessed by Investigator at baseline as part of SOC for participants with age-related macular degeneration; Standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Measured: Baseline
Number of Participants With PED at Week 6
PED assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Measured: Week 6
Number of Participants With PED at Week 12
PED assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Measured: Week 12
Number of Participants With PED at Week 18
PED assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Measured: Week 18
Number of Participants With PED at Week 24
PED assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Measured: Week 24
Number of Participants With PED at Week 30
PED assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Measured: Week 30
Number of Participants With PED at Week 36
PED assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Measured: Week 36
Number of Participants With PED at Week 42
PED assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Measured: Week 42
Number of Participants With PED at Week 48
PED assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Measured: Week 48
Number of Participants With PED at Week 54
PED assessed by Investigator Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Measured: Week 54
Number of Participants With PED at Last Visit
PED assessed by Investigator at Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. Last Visit: last available postbaseline value.
Measured: Month 24 or early termination
Central Retinal Thickness
Central retinal thickness assessed by Investigator every 6 weeks, as part of SOC, using standard clinical methods practiced (optical coherence tomography) and reported as mean central retinal thickness. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).
Measured: Baseline, every 6 weeks up to Month 24 or early termination
Number of Participants With Angiographic Subtype Reported at Baseline
Angiographic subtype assessed by Investigator at Baseline, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Measured: Baseline
Number of Participants With Angiographic Subtype Reported at Week 6
Angiographic subtype assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Measured: Week 6
Number of Participants With Angiographic Subtype Reported at Week 12
Angiographic subtype assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Measured: Week 12
Number of Participants With Angiographic Subtype Reported at Week 18
Angiographic subtype assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Measured: Week 18
Number of Participants With Angiographic Subtype Reported at Week 24
Angiographic subtype assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Measured: Week 24
Number of Participants With Angiographic Subtype Reported at Week 30
Angiographic subtype assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent (%) classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Measured: Week 30
Number of Participants With Angiographic Subtype Reported at Week 36
Angiographic subtype assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Measured: Week 36
Number of Participants With Angiographic Subtype Reported at Week 42
Angiographic subtype assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Measured: Week 42
Number of Participants With Angiographic Subtype Reported at Week 48
Angiographic subtype assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Measured: Week 48
Number of Participants With Angiographic Subtype Reported at Week 54
Angiographic subtype assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Measured: Week 54
Number of Participants With Angiographic Subtype Reported at Last Visit
Angiographic subtype assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). Last Visit: last available postbaseline value.
Measured: Month 24 or early termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2006Dec 2009

First posted22 Nov 2010 (estimated)
Study startAug 2006
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Macular DegenerationStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,001 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01245387
Sponsor's protocol ID: A5751021
Acronym: MACULA
Status last verified: Jan 2011
First submitted: 29 Sep 2010
Last updated: 13 Jan 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder

All Macular Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-Term Non-Interventional Study (AB Study) To Investigate The Efficacy And Safety Of Macugen® In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice
ClinicalTrials.gov ID: NCT01245387
Acronym / sponsor ID: MACULA / A5751021
Conditions: Macular Degeneration, Age-related Macular Degeneration, Neovascular Macular Degeneration
Keywords: prospective, observational, Phase 4, non-interventional, open-label
Study type: Observational
Recruitment status: Completed
Enrolment: 1,001 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 22 Nov 2010 (estimated)
Results: Posted 7 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Long-term observational study to assess the safety, efficacy and quality of life of patients with neovascular age-related macular degeneration (AMD) under Macugen treatment.

Detailed description

Ophthalmologists who are experienced in doing intravitreal injections in Germany

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Macugen	–	Drug: Pegaptanib

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with neovascular age-related macular degeneration

Key inclusion criteria (1 listed)

patients with neovascular age-related macular degeneration

Key exclusion criteria (1 listed)

none

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PegaptanibDosage recommendations for MACUGEN took place on the basis of the approved Summary of Product Characteristics (SmPC) and were adjusted solely according to medical practice. MACUGEN® is available as pre-filled syringe containing 0.3 mg MACUGEN® in 90 µL injection solution for intravitreal injection. Macugen injections were documented to reflect the routine clinical practice. Follow-up visits were only carried out and documented if they took place as part of the standard medical treatment for the respective case and were necessary for medical and/or therapeutic reasons.	Drug	Macugen

Primary outcome

Visual Acuity (VA)
Time frame: Baseline, every 6 weeks up to Month 24 or early termination
VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study [EDTRS]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection).
Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score
Time frame: Baseline, every 6 months up to Month 24 or early termination
Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.
Number of Participants With Investigator Assessments of Efficacy
Time frame: Month 24 or early termination
Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor.
Lesion Size (Number of Optic Disc Areas)
Time frame: Baseline, every 6 weeks up to Month 24 or early termination
Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).
Number of Participants With a Change in Activity of Neovascular Membrane at Week 6
Time frame: Week 6
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Number of Participants With a Change in Activity of Neovascular Membrane at Week 12
Time frame: Week 12
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Number of Participants With a Change in Activity of Neovascular Membrane at Week 18
Time frame: Week 18
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Number of Participants With a Change in Activity of Neovascular Membrane at Week 24
Time frame: Week 24
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Number of Participants With a Change in Activity of Neovascular Membrane at Week 30
Time frame: Week 30
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Number of Participants With a Change in Activity of Neovascular Membrane at Week 36
Time frame: Week 36
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Number of Participants With a Change in Activity of Neovascular Membrane at Week 42
Time frame: Week 42
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Number of Participants With a Change in Activity of Neovascular Membrane at Week 48
Time frame: Week 48
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Number of Participants With a Change in Activity of Neovascular Membrane at Week 54
Time frame: Week 54
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Number of Participants With a Change in Activity of Neovascular Membrane at Week 60
Time frame: Week 60
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 12, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Number of Participants With a Change in Activity of Neovascular Membrane at Week 66
Time frame: Week 66
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 13, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Number of Participants With a Change in Activity of Neovascular Membrane at Week 72
Time frame: Week 72
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 14, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit
Time frame: Month 24 or early termination
Neovascular membrane activity (measured by leakage) assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. Last Visit: last available postbaseline value.
Number of Participants With Pigment Epithelial Detachment (PED) at Baseline
Time frame: Baseline
PED assessed by Investigator at baseline as part of SOC for participants with age-related macular degeneration; Standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Number of Participants With PED at Week 6
Time frame: Week 6
PED assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Number of Participants With PED at Week 12
Time frame: Week 12
PED assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Number of Participants With PED at Week 18
Time frame: Week 18
PED assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Number of Participants With PED at Week 24
Time frame: Week 24
PED assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Number of Participants With PED at Week 30
Time frame: Week 30
PED assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Number of Participants With PED at Week 36
Time frame: Week 36
PED assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Number of Participants With PED at Week 42
Time frame: Week 42
PED assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Number of Participants With PED at Week 48
Time frame: Week 48
PED assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Number of Participants With PED at Week 54
Time frame: Week 54
PED assessed by Investigator Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Number of Participants With PED at Last Visit
Time frame: Month 24 or early termination
PED assessed by Investigator at Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. Last Visit: last available postbaseline value.
Central Retinal Thickness
Time frame: Baseline, every 6 weeks up to Month 24 or early termination
Central retinal thickness assessed by Investigator every 6 weeks, as part of SOC, using standard clinical methods practiced (optical coherence tomography) and reported as mean central retinal thickness. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).
Number of Participants With Angiographic Subtype Reported at Baseline
Time frame: Baseline
Angiographic subtype assessed by Investigator at Baseline, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Number of Participants With Angiographic Subtype Reported at Week 6
Time frame: Week 6
Angiographic subtype assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Number of Participants With Angiographic Subtype Reported at Week 12
Time frame: Week 12
Angiographic subtype assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Number of Participants With Angiographic Subtype Reported at Week 18
Time frame: Week 18
Angiographic subtype assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Number of Participants With Angiographic Subtype Reported at Week 24
Time frame: Week 24
Angiographic subtype assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Number of Participants With Angiographic Subtype Reported at Week 30
Time frame: Week 30
Angiographic subtype assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent (%) classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Number of Participants With Angiographic Subtype Reported at Week 36
Time frame: Week 36
Angiographic subtype assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Number of Participants With Angiographic Subtype Reported at Week 42
Time frame: Week 42
Angiographic subtype assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Number of Participants With Angiographic Subtype Reported at Week 48
Time frame: Week 48
Angiographic subtype assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Number of Participants With Angiographic Subtype Reported at Week 54
Time frame: Week 54
Angiographic subtype assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Number of Participants With Angiographic Subtype Reported at Last Visit
Time frame: Month 24 or early termination
Angiographic subtype assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). Last Visit: last available postbaseline value.

Results and safety

Results posted to the registry on 7 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Macugen	1,001	188

Primary outcome: Visual Acuity (VA)

Time frame: Baseline, every 6 weeks up to Month 24 or early termination. Mean (Standard Deviation). Unit: lines of VA

Measure	Macugen n = 812
Visit 1, Baseline (N=812)	8.51 (5.03)
Visit 2, Week 0, first injection (N=812)	8.72 (5.19)
Visit 3, Week 6 (N=785)	8.67 (4.90)
Visit 4, Week 12 (N=684)	8.93 (4.97)
Visit 5, Week 18 (N=537)	9.06 (4.81)
Visit 6, Week 24 (N=253)	8.83 (5.32)
Visit 7, Week 30 (N=203)	8.60 (4.69)
Visit 8, Week 36 (N=133)	8.07 (3.81)

Population analysed: Full Analysis Set (FAS):participants who received at least 1 Macugen (pegaptanib) injection and had at least 1 VA measurement postbaseline. Participants with light perception or no light perception any time during study were excluded from FAS; N=participants with evaluable data; Last Visit: last available postbaseline value.

Primary outcome: Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score

Time frame: Baseline, every 6 months up to Month 24 or early termination. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Macugen n = 485
Visit 1, Baseline (N=485)	54.05 (23.50)
Visit 2, Month 6 (N=219)	55.56 (22.17)
Visit 3, Month 12 (N=167)	57.13 (21.60)
Visit 4, Month 18 (N=135)	56.95 (20.58)
Visit 5, Month 24 (N=338)	56.09 (23.73)
Last Visit (N=410)	54.90 (23.86)

Population analysed: FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.

Primary outcome: Number of Participants With Investigator Assessments of Efficacy

Time frame: Month 24 or early termination. Number. Unit: Participants

Measure	Macugen n = 604
Very Good	36
Good	226
Moderate	168
Poor	174

Population analysed: FAS; N = number of participants with evaluable data.

Primary outcome: Lesion Size (Number of Optic Disc Areas)

Time frame: Baseline, every 6 weeks up to Month 24 or early termination. Mean (Standard Deviation). Unit: number of optic disc areas

Measure	Macugen n = 712
Visit 1, Baseline (N=712)	2.4 (1.6)
Visit 3, Week 6 (N=190)	2.1 (1.2)
Visit 4, Week 12 (N=173)	2.3 (1.7)
Visit 5, Week 18 (N=316)	2.2 (2.0)
Visit 6, Week 24 (N=45)	2.3 (1.3)
Visit 7, Week 30 (N=45)	3.2 (2.1)
Visit 8, Week 36 (N=78)	2.8 (2.0)
Visit 9, Week 42 (N=15)	2.5 (1.3)

Population analysed: FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Macugen	16 of 816 (2%)	12 of 816 (1.5%)	Not reported

Limitations and caveats (from the sponsor): Time to first AE not estimated due to insufficient number of events. Visit numbers for NEI-VFQ-25 deviated from numbering used in other analyses; it represents the sequence number of questionaries administered (Visit 1=first assessment, etc.).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Macular Degeneration and Age-related Macular Degeneration, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Acuity (VA) (time frame: Baseline, every 6 weeks up to Month 24 or early termination). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01245387.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2011.