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

Phase 4

Completed

Conditions: Macular Degeneration

Interventions: Drug: pegaptanib sodium (Macugen)

Registration Number: NCT00324116

Lead Sponsor: Pfizer

Brief 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 neovascularization.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 81

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	pegaptanib sodium (Macugen)	-

Primary Outcome Measures

Name	Time	Method
Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Visual Acuity	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.
Number of Subjects Gaining Vision	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.
Number of Subjects Maintaining Vision	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.
Number of Subjects With Severe Visual Loss	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.
Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)	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.
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).	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.