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

Sponsor:	Pfizer
Collaborator:	ITEC GROUP 3
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00324116

Purpose

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.

Condition	Intervention	Phase
Macular Degeneration	Drug: pegaptanib sodium (Macugen)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Pegaptanib sodium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) [ Time Frame: Baseline, 54 Weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Change From Baseline in Visual Acuity [ Time Frame: Baseline, 6 weeks, 12 weeks, 54 weeks ] [ Designated as safety issue: No ]
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.
Number of Subjects Gaining Vision [ Time Frame: 54 weeks or at early termination ] [ Designated as safety issue: No ]
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.
Number of Subjects Maintaining Vision [ Time Frame: 54 weeks or at early termination ] [ Designated as safety issue: No ]
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.
Number of Subjects With Severe Visual Loss [ Time Frame: 54 weeks or at early termination ] [ Designated as safety issue: No ]
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.
Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200) [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
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.

Enrollment:	81
Study Start Date:	July 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active	Drug: pegaptanib sodium (Macugen) 0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks. Other Name: MACUGEN

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324116

Locations

France
Pfizer Investigational Site
Angers, Cedex 09, France, 49933
Pfizer Investigational Site
Lyon, Cedex 4, France, 69317
Pfizer Investigational Site
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
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
Marseille, France, 13008
Pfizer Investigational Site
Montpellier, France, 34000
Pfizer Investigational Site
Montpellier, France, 34070
Pfizer Investigational Site
MULHOUSE Cedex 1, France, 68070
Pfizer Investigational Site
Nancy, France, 54000
Pfizer Investigational Site
Nantes Cedex 1, France, 44093
Pfizer Investigational Site
Paris, France, 75006
Pfizer Investigational Site
Paris, France, 75015
Pfizer Investigational Site
Paris cedex 12, France, 75557
Pfizer Investigational Site
PARIS Cedex 19, France, 75940
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

Sponsors and Collaborators

Pfizer

ITEC GROUP 3

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00324116 History of Changes
Other Study ID Numbers:	A5751016
Study First Received:	May 8, 2006
Results First Received:	August 25, 2009
Last Updated:	March 15, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 12, 2012