Macular DegenerationNCT00460408

Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration

An observational study of Macular Degeneration, run by Pfizer at 68 sites in 13 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Macular Degeneration
What is being tested?: Macugen
Type of treatment: Injection or infusion
How many people: 501 participants
Where: 68 sitesin 13 countries
Study dates: Aug 2006to Feb 2012
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 age-related macular degeneration

Who may be able to join

Neovascular AMD patients who are eligible for Macugen therapy based on the approved label

Who cannot join

Active or suspected ocular or periocular infection. Known hypersensitivity to the active substance or any of its excipients.

Trial locations and contacts

68 sites in 13 countries.

Country

City, postcode or hospital

68 sites in 13 countries

Greece10 sites

Pfizer Investigational Site
Athens, 10672
Pfizer Investigational Site
Athens, 115 27
Pfizer Investigational Site
Athens, 11526
Pfizer Investigational Site
Heraklion, Crete, 71110
Pfizer Investigational Site
Heraklion, 71001
Pfizer Investigational Site
Ioannina, 45500
Pfizer Investigational Site
Kavala
Pfizer Investigational Site
Nikaia, Piraeus, 18454
Pfizer Investigational Site
Thessaloniki, 54636
Pfizer Investigational Site
Thessaloniki, 54642

Other trials in Greece

Slovakia9 sites

Pfizer Investigational Site
Banská Bystrica, 975 17
Pfizer Investigational Site
Bratislava, 826 06
Pfizer Investigational Site
Bratislava, 851 03
Pfizer Investigational Site
Košice, 041 66
Pfizer Investigational Site
Prešov, 08001
Pfizer Investigational Site
Prešov, 081 81
Pfizer Investigational Site
Ružomberok, 03426
Pfizer Investigational Site
Trenčín, 911 71
Pfizer Investigational Site
Žilina, 012 07

Other trials in Slovakia

Germany8 sites

Pfizer Investigational Site
Augsburg, 86156
Pfizer Investigational Site
Frankfurt, 60318
Pfizer Investigational Site
Karlsruhe, 76137
Pfizer Investigational Site
Konstanz, 78462
Pfizer Investigational Site
Ludwigshafen, 67063
Pfizer Investigational Site
München, 81675
Pfizer Investigational Site
Münster, 48145
Pfizer Investigational Site
Weilheim, 82362

Other trials in Germany

Italy8 sites

Pfizer Investigational Site
Arona, NO, 28041
Pfizer Investigational Site
Bologna, 40138
Pfizer Investigational Site
Cagliari, 09100
Pfizer Investigational Site
Monza, MI, 20052
Pfizer Investigational Site
Naples, 80131
Pfizer Investigational Site
Pisa, 56124
Pfizer Investigational Site
Rieti, 02100
Pfizer Investigational Site
Siena, 53100

Other trials in Italy

Spain8 sites

Pfizer Investigational Site
Alcalá de Henares, Madrid, 28805
Pfizer Investigational Site
Madrid, Madrid, 28040
Pfizer Investigational Site
Pamplona, Navarre, 31008
Pfizer Investigational Site
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010
Pfizer Investigational Site
Santiago de Compostela, A Coruña, 15706
Pfizer Investigational Site
Valencia, Valencia, 46014
Pfizer Investigational Site
Valencia, Valencia, 46015
Pfizer Investigational Site
Valladolid, Valladolid, 47010

Other trials in Spain

Czechia6 sites

Pfizer Investigational Site
Brno, 625 00
Pfizer Investigational Site
Hradec Králové, 500 05
Pfizer Investigational Site
Pilsen, 304 60
Pfizer Investigational Site
Prague, 10034
Pfizer Investigational Site
Prague, 128 08
Pfizer Investigational Site
Prague, 169 02

Other trials in Czechia

France6 sites

Pfizer Investigational Site
Argonay, 74370
Pfizer Investigational Site
Dijon, 21055
Pfizer Investigational Site
Grenoble, 38100
Pfizer Investigational Site
Le Golfe Juan, 06220
Pfizer Investigational Site
Marseille, 13285
Pfizer Investigational Site
Rennes, 35033

Other trials in France

Belgium5 sites

Pfizer Investigational Site
Brussels, 1200
Pfizer Investigational Site
Charleroi, 6000
Pfizer Investigational Site
Ieper, 8900
Pfizer Investigational Site
Lier, 2500
Pfizer Investigational Site
Turnhout, 2300

Other trials in Belgium

Poland3 sites

Pfizer Investigational Site
Bydgoszcz, 85 - 094
Pfizer Investigational Site
Szczecin, 70 - 111
Pfizer Investigational Site
Warsaw, 04-141

Other trials in Poland

Sweden2 sites

Pfizer Investigational Site
Stockholm, 118 83
Pfizer Investigational Site
Västerås, 721 89

Other trials in Sweden

Cyprus1 site

Pfizer Investigational Site
Limassol, 1430

Other trials in Cyprus

Denmark1 site

Pfizer Investigational Site
Sønderborg, 6400

Other trials in Denmark

Ireland1 site

Pfizer Investigational Site
Waterford

Other trials in Ireland

About this study

Official title: European Epidemiologic COHORT Study: A Prospective Epidemiologic COHORT Study Of Ocular Safety In Patients Receiving Macugen Injections For Neovascular Age-Related Macular Degeneration (AMD) In Europe

The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.

Read the detailed description

No comparator Patients with age-related macular degeneration

Conditions: Macular Degeneration
Being tested: Macugen
Keywords: Macular degeneration, Safety, Non-interventional, Non-randomized
Medical subject headings: Macular Degeneration

What participants receive

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

MacugenDrug
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.

Study groups in NCT00460408
Study group	Role	What they receive
Observational study, no comparator		Observational study of patients with AMD treated with Macugen, no comparator Receives: Drug: Macugen

What is being measured

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

Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection
POAEs: primarily endophthalmitis, as well as increased intraocular pressure (IOP), vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection equals (=) number of specific POAEs divided by the total number of injections received.
Measured: Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Gender (Females)
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.
Measured: Baseline up to 2 years

Secondary outcomes (6)

Incidence of POAEs Per Injection Reported by Gender (Males)
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.
Measured: Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.
Measured: Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.
Measured: Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.
Measured: Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.
Measured: Baseline up to 2 years
Number of Participants With Serious Hypersensitivity Reactions
Hypersensitivity reactions include Hypersensitivity, Drug hypersensitivity, Anaphylactic shock, Anaphylactic reaction, Anaphylactoid shock, Angioedema Anaphylactoid reaction, Blepharitis allergic, Dermatitis contact, Dermatitis allergic, Toxic skin eruption, Toxic epidermal necrolysis, Drug eruption, Erythema, Erythema multiforme, Tongue oedema, Pharyngeal oedema, Laryngeal oedema, Latex allergy, Paraesthesia oral, Paraesthesia mucosal, Urticaria, Stevens-Johnson syndrome, Rash, Skin reaction, Acute generalised exanthematous pustulosis, Drug rash with eosinphilia and systemic symptoms.
Measured: Baseline up to 2 years

Timeline

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

Aug 2006Feb 2012

First posted16 Apr 2007 (estimated)
Study startAug 2006
Primary completionFeb 2012
Study completionFeb 2012

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
Time perspective: Prospective
Enrolment: 501 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00460408
Sponsor's protocol ID: A5751019
Status last verified: Nov 2012
First submitted: 13 Apr 2007
Last updated: 11 Dec 2012
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?

See locations

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 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: European Epidemiologic COHORT Study: A Prospective Epidemiologic COHORT Study Of Ocular Safety In Patients Receiving Macugen Injections For Neovascular Age-Related Macular Degeneration (AMD) In Europe
ClinicalTrials.gov ID: NCT00460408
Acronym / sponsor ID: A5751019
Conditions: Macular Degeneration
Keywords: Macular degeneration, Safety, Non-interventional, Non-randomized
Study type: Observational
Recruitment status: Completed
Enrolment: 501 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 16 Apr 2007 (estimated)
Results: Posted 11 Dec 2012

Clinical summary

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

Detailed description

No comparator Patients with age-related macular degeneration

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Observational study, no comparator	–	Drug: MacugenObservational study of patients with AMD treated with Macugen, no comparator

Who may qualify

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

Key inclusion criteria (1 listed)

Neovascular AMD patients who are eligible for Macugen therapy based on the approved label

Key exclusion criteria (1 listed)

Active or suspected ocular or periocular infection. Known hypersensitivity to the active substance or any of its excipients.

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
MacugenIntravitreal injection of Macugen 0.3mg/90ul every 6 weeks.	Drug	Observational study, no comparator

Primary outcome

Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection
Time frame: Baseline up to 2 years
POAEs: primarily endophthalmitis, as well as increased intraocular pressure (IOP), vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection equals (=) number of specific POAEs divided by the total number of injections received.
Incidence of POAEs Per Injection Reported by Gender (Females)
Time frame: Baseline up to 2 years
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.

6 secondary outcomes

Incidence of POAEs Per Injection Reported by Gender (Males)
Time frame: Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)
Time frame: Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)
Time frame: Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)
Time frame: Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)
Time frame: Baseline up to 2 years
Number of Participants With Serious Hypersensitivity Reactions
Time frame: Baseline up to 2 years

Results and safety

Results posted to the registry on 11 Dec 2012, 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	403	336
Macugen and Avastin	16	13
Macugen and Lucentis	75	69
Macugen and Other AMD Drugs	7	7

Primary outcome: Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection

Time frame: Baseline up to 2 years. Number. Unit: percent per injection

Measure	Macugen n = 403	Macugen and Avastin n = 16	Macugen and Lucentis n = 75	Macugen and Other AMD Drugs n = 7
Increased IOP	1.34	2.19	0.48	2.50
Vitreous hemorrhage	0.10	0.73	0	0
Traumatic cataract	0.13	0	0	0
Retinal detachment	0.03	0	0	0
Retinal tear	0.03	0	0	0
Endophthalmitis	0	0	0	0

Population analysed: Safety Population: participants who received at least 1 Macugen (pegaptanib sodium) injection; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.

Primary outcome: Incidence of POAEs Per Injection Reported by Gender (Females)

Time frame: Baseline up to 2 years. Number. Unit: percent per injection

Measure	Macugen n = 245	Macugen and Avastin n = 11	Macugen and Lucentis n = 46	Macugen and Other AMD Drugs n = 5
Increased IOP	1.12	3.19	0.78	3.70
Traumatic cataract	0.17	0	0	0
Endophthalmitis	0	0	0	0

Population analysed: Safety Population subset of female participants; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Macugen	21 of 403 (5.2%)	65 of 403 (16.1%)	Not reported
Macugen and Avastin	0 of 16 (0%)	4 of 16 (25%)	Not reported
Macugen and Lucentis	2 of 75 (2.7%)	14 of 75 (18.7%)	Not reported
Macugen and Other AMD Drugs	0 of 7 (0%)	4 of 7 (57.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 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.

Related trials for Macular Degeneration

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

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

68 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Macular Degeneration, run by Pfizer at 68 sites in 13 countries.

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 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in Greece, Slovakia, Germany, Italy, Spain and 8 more countries. 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 Dec 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?

Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection (time frame: Baseline up to 2 years). The study lists 2 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 NCT00460408.

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 Dec 2012.