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

This study has been completed.
Sponsor:
Information provided by:
Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00021736
First received: August 3, 2001
Last updated: June 23, 2005
Last verified: July 2002
History of Changes
  Purpose

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


Condition Intervention Phase
Macular Degeneration
Choroidal Neovascularization
 Drug: EYE001 anti-VEGF aptamer
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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).

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Eyetech Pharmaceuticals:

Estimated Enrollment: 540
Study Start Date: July 2001
Estimated Study Completion Date: July 2002
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00021736

Locations
United States, Maryland
Foundation for Fighting Blindness
Baltimore, Maryland, United States
Sponsors and Collaborators
Eyetech Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00021736     History of Changes
Other Study ID Numbers: EOP1004B
Study First Received: August 3, 2001
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Eyetech Pharmaceuticals:
choroidal neovascularization (CNV)
subretinal neovascularization

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
 Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013