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Safety & Efficacy Study of rhuFab V2 in Combination with Verteporfin for treatment of Age-related Macular Degeneration



Safety & Efficacy Study of rhuFab V2 in Combination with Verteporfin for treatment of Age-related Macular Degeneration

For Condition: Age-Related Maculopathy
Status: No longer recruiting
Sponsor(s): Genentech ,
Synopsis: The primary purpose of this study is to determine if injections of rhuFab V2 into the eye in combination with verteporfin photodynamic therapy is a safe and efficacious treatment for patients with age-related macular degeneration.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Dose Comparison, Crossover 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: predominantly classic choroidal neovascularization (CNV) due to AMD and not another cause. The CNV lesion size must be eligible for photodynamic therapy (PDT) with verteporfin according to the product labeling. - Subjects who have already had verteporfin PDT in the study eye may be eligible provided the interval since the last treatment is 3 months or more and other conditions are met. 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 had laser treatment involving the center of the fovea or undergone experimental treatments for wet AMD (including drugs, surgery, external beam radiation, or transpupillary thermotherapy).
Total Enrollment: 168

Location and Contact Information:

Trial Information Support Center
Denver,  Colorado, 
United States
 


Additional Information:
Study ID Numbers:
  FVF2428g; 
Study Start Date: March 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056823

Other Age-Related Maculopathy Studies:
1. Efficacy and Safety Study of rhuFab V2 (Ranibizumab) to Treat Age-Related Macular Degeneration

2. Safety & Efficacy Study of rhuFab V2 in Combination with Verteporfin for treatment of 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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