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Efficacy and Safety Study of rhuFab V2 (Ranibizumab) to Treat Age-Related Macular Degeneration



Efficacy and Safety Study of rhuFab V2 (Ranibizumab) to Treat Age-Related Macular Degeneration

For Condition: Age-Related Maculopathy
Status: No longer recruiting
Sponsor(s): Genentech ,
Synopsis: The purpose of this study is to determine whether injections of rhuFab into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 50 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA - Subjects aged 50 years or older, with wet age-related macular degeneration (AMD) involving the center of the fovea ("subfoveal"), and best corrected visual acuity of equal to or worse than 20/40 but no worse than 20/320 in the study eye are potentially eligible. - The wet subfoveal AMD must be of a specific type: active, minimally classic or occult choroidal neovascularization (CNV) due to AMD and not another cause. - Subjects who have had laser treatment in the study eye may be eligible if the center of the fovea was not treated and other conditions are met. EXCLUSION CRITERIA - Subjects are ineligible if they have undergone laser treatment involving the center of the fovea, verteporfin photodynamic therapy, or experimental treatments for wet AMD (including drugs, surgery, external beam radiation, or transpupillary thermotherapy).
Total Enrollment: 720

Location and Contact Information:

Trial Information Support Center
Denver,  Colorado, 
United States
 


Additional Information:
Study ID Numbers:  FVF2598g; 
Study Start Date: March 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056836

Other Age-Related Maculopathy Studies:
1. Safety & Efficacy Study of rhuFab V2 in Combination with Verteporfin for treatment of Age-related Macular Degeneration

2. Efficacy and Safety Study of rhuFab V2 (Ranibizumab) to Treat Age-Related Macular Degeneration

3. An evaluation of safety and efficacy of Anecortave Acetate vs. placebo in patients with subfoveal choroidal neovascularization(CNV) due to wet age-related macular degeneration(AMD)

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