Back to resultsPhase II/III Study of Anti-VEGF in Neovascular AMD
Primary Purpose
Macular Degeneration, Choroidal Neovascularization
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EYE001 anti-VEGF aptamer
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring choroidal neovascularization (CNV), subretinal neovascularization
Eligibility Criteria
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.
Sites / Locations
- Foundation for Fighting Blindness
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00021736
Brief Title
Phase II/III Study of Anti-VEGF in Neovascular AMD
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).
Study Type
Interventional
2. Study Status
Record Verification Date
July 2002
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eyetech Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Choroidal Neovascularization
Keywords
choroidal neovascularization (CNV), subretinal neovascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
540 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
EYE001 anti-VEGF aptamer
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Foundation for Fighting Blindness
City
Baltimore
State/Province
Maryland
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II/III Study of Anti-VEGF in Neovascular AMD
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