Neovascular Age-related Macular DegenerationMACULANCT00858208
Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.
An observational study of Neovascular Age-related Macular Degeneration, run by Pfizer at 8 sites in Greece.
Trial summary
Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- pegaptanib sodium
- Type of treatment
- Injection or infusion
- How many people
- 86 participants
- Where
- 8 sitesGreece
- Study dates
- Mar 2008to Apr 2011
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Age-related Macula degeneration
Who may be able to join
- adults with neovascular age-related macula degeneration
Who cannot join
- according to SmPC
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Greece8 sites
Pfizer Investigational Site
Alexandroupoli
Pfizer Investigational Site
Athens, 12462
Pfizer Investigational Site
Athens
Pfizer Investigational Site
Larissa
Pfizer Investigational Site
Pátrai, Pellopoese
Pfizer Investigational Site
Pátrai
Pfizer Investigational Site
Thessaloniki
Pfizer Investigational Site
Xánthi
About this study
Official title: Long-Term Non-Interventional Study To Investigate The Efficacy And Safety Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice.
Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials.
Read the detailed description
Eligible patients in routine clinical practice
- Being tested
- pegaptanib sodium
- Keywords
- efficacy and safety of Macugen in routine clinical practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegaptanib sodiumDrug
pegaptanib sodium intravitreal injection every 6 weeks for 2 years
| Study group | Role | What they receive |
|---|---|---|
| Patients with neovascular Age-Related Macula Degeneration | Not described Receives: Drug: pegaptanib sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Visual Acuity (VA) at the Final Visit
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
Measured: Baseline, Week 102 or Early Termination (ET)
Secondary outcomes (5)
Change From Baseline VA at Each Visit
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
Measured: Baseline, every 6 weeks up to Week 102
Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the "Pigment Epithelial Detachment (PED) present" box ticked at Baseline Visit.
Measured: Baseline, Week 102 or ET
Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
Measured: Baseline, Month 6, 12, 18, and 24
Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
Measured: Baseline, Week 102 or ET
Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning.
Measured: Baseline, Week 102 or ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startMar 2008
- Primary completionApr 2011
- Study completionApr 2011
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 Neovascular Age-related 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858208
- Sponsor's protocol ID
- A5751028
- Acronym
- MACULA
- Status last verified
- Sep 2011
- First submitted
- 26 Feb 2009
- Last updated
- 11 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Non-Interventional 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
- NCT00858208
- Acronym / sponsor ID
- MACULA / A5751028
- Keywords
- efficacy and safety of Macugen in routine clinical practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Posted 11 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials.
Detailed description
Eligible patients in routine clinical practice
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with neovascular Age-Related Macula Degeneration | – | Drug: pegaptanib sodium |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Age-related Macula degeneration
Key inclusion criteria (1 listed)
- adults with neovascular age-related macula degeneration
Key exclusion criteria (1 listed)
- according to SmPC
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 |
|---|---|---|
| pegaptanib sodiumpegaptanib sodium intravitreal injection every 6 weeks for 2 years | Drug | Patients with neovascular Age-Related Macula Degeneration |
Primary outcome
Change From Baseline Visual Acuity (VA) at the Final Visit
Time frame: Baseline, Week 102 or Early Termination (ET)
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
5 secondary outcomes
Change From Baseline VA at Each Visit
Time frame: Baseline, every 6 weeks up to Week 102
Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)
Time frame: Baseline, Week 102 or ET
Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
Time frame: Baseline, Month 6, 12, 18, and 24
Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit
Time frame: Baseline, Week 102 or ET
Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Time frame: Baseline, Week 102 or ET
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
- 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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-related Macular Degeneration, run by Pfizer at 8 sites in Greece.
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 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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 11 Apr 2012). 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?
Change From Baseline Visual Acuity (VA) at the Final Visit (time frame: Baseline, Week 102 or Early Termination (ET)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2012; AzTrials last refreshed its copy on 8 Nov 2026.