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

March 15, 2010 updated by: Pfizer

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

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 neovascularization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bayonne, France, 64100
        • Pfizer Investigational Site
      • Belfort Cedex, France, 90016
        • Pfizer Investigational Site
      • Bordeaux, France, 33076
        • Pfizer Investigational Site
      • Bordeaux, France, 33100
        • Pfizer Investigational Site
      • Brest, France, 29200
        • Pfizer Investigational Site
      • DIJON Cedex, France, 21033
        • Pfizer Investigational Site
      • La Rochefoucauld, France, 16110
        • Pfizer Investigational Site
      • La Tronche, France, 38700
        • Pfizer Investigational Site
      • Lille, France, 59800
        • Pfizer Investigational Site
      • Limoges Cedex 1, France, 87042
        • Pfizer Investigational Site
      • Lyon, France, 69003
        • Pfizer Investigational Site
      • MULHOUSE Cedex 1, France, 68070
        • Pfizer Investigational Site
      • Marseille, France, 13008
        • Pfizer Investigational Site
      • Montpellier, France, 34000
        • Pfizer Investigational Site
      • Montpellier, France, 34070
        • Pfizer Investigational Site
      • Nancy, France, 54000
        • Pfizer Investigational Site
      • Nantes Cedex 1, France, 44093
        • Pfizer Investigational Site
      • PARIS Cedex 19, France, 75940
        • Pfizer Investigational Site
      • Paris, France, 75015
        • Pfizer Investigational Site
      • Paris, France, 75006
        • Pfizer Investigational Site
      • Paris cedex 12, France, 75557
        • Pfizer Investigational Site
      • Rives, France, 38140
        • Pfizer Investigational Site
      • Rouen, France, 76000
        • Pfizer Investigational Site
      • Saint-Herblain, France, 44819
        • Pfizer Investigational Site
      • Strasbourg, France, 67000
        • Pfizer Investigational Site
      • Strasbourg Cedex, France, 67091
        • Pfizer Investigational Site
      • Toulouse, France, 31054
        • Pfizer Investigational Site
      • Toulouse, France, 31200
        • Pfizer Investigational Site
    • Cedex
      • Besancon, Cedex, France, 25030
        • Pfizer Investigational Site
      • Creteil, Cedex, France, 94010
        • Pfizer Investigational Site
      • Macon, Cedex, France, 71018
        • Pfizer Investigational Site
      • Poitiers, Cedex, France, 86021
        • Pfizer Investigational Site
    • Cedex 09
      • Angers, Cedex 09, France, 49933
        • Pfizer Investigational Site
    • Cedex 4
      • Lyon, Cedex 4, France, 69317
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Drug: pegaptanib sodium (Macugen)
0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.
Other Names:
  • MACUGEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 54 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Visual Acuity
Time Frame: Baseline, 6 weeks, 12 weeks, 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. Change: mean score at observation minus mean score at baseline.
Baseline, 6 weeks, 12 weeks, 54 weeks
Number of Subjects Gaining Vision
Time Frame: 54 weeks or at early termination
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.
54 weeks or at early termination
Number of Subjects Maintaining Vision
Time Frame: 54 weeks or at early termination
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.
54 weeks or at early termination
Number of Subjects With Severe Visual Loss
Time Frame: 54 weeks or at early termination
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.
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

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.
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
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.
Baseline, 54 weeks or at early termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

ITEC GROUP 3

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria

May 9, 2006

First Posted (Estimate)

May 10, 2006

Study Record Updates

Last Update Posted (Estimate)

March 23, 2010

Last Update Submitted That Met QC Criteria

March 15, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5751016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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