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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Macular Degeneration

Treatments

Drug: pegaptanib sodium (Macugen)

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00324116

A5751016

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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