Macular DegenerationPhase 4NCT00324116

Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions

A Phase 4 study testing pegaptanib sodium (Macugen) in people with Macular Degeneration, run by Pfizer at 34 sites in France.

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

To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal… Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Macular Degeneration
What is being tested?: pegaptanib sodium (Macugen)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 34 sitesFrance
Study dates: Jul 2006to Aug 2008
Phase: Phase 4
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical and angiographic evidence of juxtafoveal or subfoveal choroidal neovascularization secondary to AMD with a total lesion size of less than 2 MPS disc areas
Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS)
Women must be using 2 forms of effective contraception
Adequate hematological, renal and liver functions

Who cannot join

Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area
Any extrafoveal choroidal neovascularization
Any intraocular surgery or thermal laser to the study eye within 3 months of enrollment
Previous or concomitant therapy for AMD including PDT with verteporfin (Visudyne) or subfoveal/non-foveal thermal laser therapy, transpupillary thermotherapy, external beam radiation, submacular surgery.
Presence of other causes of choroidal neovascularization, including pathological myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

France34 sites

Pfizer Investigational Site
Angers, Cedex 09, 49933
Pfizer Investigational Site
Bayonne, 64100
Pfizer Investigational Site
Belfort, 90016
Pfizer Investigational Site
Besançon, Cedex, 25030
Pfizer Investigational Site
Bordeaux, 33076
Pfizer Investigational Site
Bordeaux, 33100
Pfizer Investigational Site
Brest, 29200
Pfizer Investigational Site
Créteil, Cedex, 94010
Pfizer Investigational Site
Dijon, 21033
Pfizer Investigational Site
La Rochefoucauld, 16110
Pfizer Investigational Site
La Tronche, 38700
Pfizer Investigational Site
Lille, 59800
Pfizer Investigational Site
Limoges, 87042
Pfizer Investigational Site
Lyon, Cedex 4, 69317
Pfizer Investigational Site
Lyon, 69003
Pfizer Investigational Site
Mâcon, Cedex, 71018
Pfizer Investigational Site
Marseille, 13008
Pfizer Investigational Site
Montpellier, 34000
Pfizer Investigational Site
Montpellier, 34070
Pfizer Investigational Site
Mulhouse, 68070
Pfizer Investigational Site
Nancy, 54000
Pfizer Investigational Site
Nantes, 44093
Pfizer Investigational Site
Paris, 75006
Pfizer Investigational Site
Paris, 75015
Pfizer Investigational Site
Paris, 75557
Pfizer Investigational Site
Paris, 75940
Pfizer Investigational Site
Poitiers, Cedex, 86021
Pfizer Investigational Site
Rives, 38140
Pfizer Investigational Site
Rouen, 76000
Pfizer Investigational Site
Saint-Herblain, 44819
Pfizer Investigational Site
Strasbourg, 67000
Pfizer Investigational Site
Strasbourg, 67091
Pfizer Investigational Site
Toulouse, 31054
Pfizer Investigational Site
Toulouse, 31200

Other trials in France

About this study

Official title: A Prospective, Open-Label Multi Center Trial Evaluating The Safety And Efficacy Of 0.3 Mg/Eye Pegaptanib Sodium (Macugen) Intravitreous Injection Given Every 6 Weeks For 54 Weeks In Patients With Small Neovascular Age-Related Macular Degeneration (AMD) Lesions

Conditions: Macular Degeneration
Being tested: pegaptanib sodium (Macugen)
Medical subject headings: Macular Degeneration

What participants receive

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

pegaptanib sodium (Macugen)Drug
Also called MACUGEN
0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.

Study groups in NCT00324116
Study group	Role	What they receive
Active	Experimental	Not described Receives: Drug: pegaptanib sodium (Macugen)

What is being measured

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

Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)
Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.
Measured: Baseline, 54 Weeks

Secondary outcomes (6)

Change From Baseline in Visual Acuity
Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline.
Measured: Baseline, 6 weeks, 12 weeks, 54 weeks
Number of Subjects Gaining Vision
Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
Measured: 54 weeks or at early termination
Number of Subjects Maintaining Vision
Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
Measured: 54 weeks or at early termination
Number of Subjects With Severe Visual Loss
Subjects with severe visual loss: loss from baseline of >= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
Measured: 54 weeks or at early termination
Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)
Subjects with improving scores are those with > 20/200 at Baseline and progressing to =< 20/200 at Week 54.
Subjects with no change are those with > 20/200 at Baseline and remaining at > 20/200 at Week 54.
Measured: 54 weeks
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).
Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; 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, 54 weeks or at early termination

Timeline

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

Jul 2006Aug 2008

First posted10 May 2006 (estimated)
Study startJul 2006
Primary completionAug 2008
Study completionAug 2008

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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00324116
Sponsor's protocol ID: A5751016
Status last verified: Mar 2010
First submitted: 8 May 2006
Last updated: 23 Mar 2010
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

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A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
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Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
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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
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RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
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All Macular Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Open-Label Multi Center Trial Evaluating The Safety And Efficacy Of 0.3 Mg/Eye Pegaptanib Sodium (Macugen) Intravitreous Injection Given Every 6 Weeks For 54 Weeks In Patients With Small Neovascular Age-Related Macular Degeneration (AMD) Lesions
ClinicalTrials.gov ID: NCT00324116
Acronym / sponsor ID: A5751016
Conditions: Macular Degeneration
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: ITEC GROUP 3
Study start: Jul 2006
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 10 May 2006 (estimated)
Results: Posted 2 Oct 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Active	Experimental	Drug: pegaptanib sodium (Macugen)

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Clinical and angiographic evidence of juxtafoveal or subfoveal choroidal neovascularization secondary to AMD with a total lesion size of less than 2 MPS disc areas
Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS)
Women must be using 2 forms of effective contraception
Adequate hematological, renal and liver functions

Key exclusion criteria (5 listed)

Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area
Any extrafoveal choroidal neovascularization
Any intraocular surgery or thermal laser to the study eye within 3 months of enrollment
Previous or concomitant therapy for AMD including PDT with verteporfin (Visudyne) or subfoveal/non-foveal thermal laser therapy, transpupillary thermotherapy, external beam radiation, submacular surgery.
Presence of other causes of choroidal neovascularization, including pathological myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis

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 sodium (Macugen)Also: MACUGEN0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.	Drug	Active

Primary outcome

Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)
Time frame: Baseline, 54 Weeks
Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.

6 secondary outcomes

Change From Baseline in Visual Acuity
Time frame: Baseline, 6 weeks, 12 weeks, 54 weeks
Number of Subjects Gaining Vision
Time frame: 54 weeks or at early termination
Number of Subjects Maintaining Vision
Time frame: 54 weeks or at early termination
Number of Subjects With Severe Visual Loss
Time frame: 54 weeks or at early termination
Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)
Time frame: 54 weeks
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).
Time frame: Baseline, 54 weeks or at early termination

Results and safety

Results posted to the registry on 2 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pegaptanib Sodium	81	49

Primary outcome: Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)

Time frame: Baseline, 54 Weeks. Number. Unit: participants

Measure	Pegaptanib Sodium n = 80
Responders	40 (76 to 95)
Non-Responders	7
Censored (subjects with missing data)	33

Pegaptanib Sodium: percent responders: 85 (95% CI 76 to 95)

Population analysed: The full analysis set (FAS) was derived from the set of all enrolled subjects who 1) were administered the study medication AND 2) had post-baseline documentation of efficacy available. In the case of missing data post-baseline, the subject was considered censored at the time of the last available data for the score.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pegaptanib Sodium	8 of ?	28 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2010.
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

34 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing pegaptanib sodium (Macugen) in people with Macular Degeneration, run by Pfizer at 34 sites in France.

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 4 inclusion and 5 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 23 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in France. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2009). 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?

Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) (time frame: Baseline, 54 Weeks). 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 NCT00324116.

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 23 Mar 2010.