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

Phase 2

Completed

• Conditions: Macular Degeneration; Choroidal Neovascularization

• Registration Number: NCT00021736
• Lead Sponsor: Eyetech Pharmaceuticals

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2001-07
• Study First Submitted: 2001-08-03
• Study First Submitted QC: 2001-08-04
• Study First Posted: 2001-08-06
• Status Verified: 2002-07
• Study Completion: 2002-07
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Foundation for Fighting Blindness; 🇺🇸 Baltimore, Maryland, United States