Phase II/III Study of Anti-VEGF in Neovascular AMD

Eyetech Pharmaceuticals540 enrolled

Overview

The purpose of the study is to determine whether the anti-VEGF drug is effective at stabilizing and/or improving vision in patients with the wet form of AMD

This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center, by percentage of classic CNV vessels: \[predominantly classic (\>50%) vs. minimally classic (1-49%) vs. purely occult (0%)\], and according to whether, or not, they have received prior PDT with Visudyne (no more than once). All patients will be re-randomized after 54 weeks of treatment to either, continue or discontinue therapy for further 48 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

540

Conditions

Macular Degeneration Choroidal Neovascularization

Interventions

EYE001 anti-VEGF aptamerDRUG

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Patients of either gender, aged 50 years or above, diagnosed with subfoveal CNV secondary to AMD and with best corrected visual acuity of 20/40 to 20/320 in the absence of subfoveal atrophy or scarring in the study eye, and better or equal to 20/800 in the fellow eye, may be enrolled. Clinically significant concomitant diseases will be excluded.

Locations (1)

Foundation for Fighting Blindness

Baltimore, Maryland, United States

Data from ClinicalTrials.gov

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