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

Macular Degeneration Clinical Trial

Official title:

Phase II/III Randomized, Double-Masked, Trial, to Establish the Safety and Efficacy of Intravitreal Injections of EYE001 (Anti-VEGF Pegylated Aptamer) Given Every 6 Weeks for 54 Weeks, in Patients With Exudative AMD).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00021736
• Other study ID #: EOP1004B
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 3, 2001
• Last updated: June 23, 2005
• Start date: July 2001
• Est. completion date: July 2002

Study information

• Verified date: July 2002
• Source: Eyetech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• EYE001 anti-VEGF aptamer

Locations

Country	Name	City	State
United States	Foundation for Fighting Blindness	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Eyetech Pharmaceuticals

Country where clinical trial is conducted

United States,