Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Safety and Efficacy of Ranibizumab in Glaucoma Patients Treated With Filtration Tubes"|
- Tube Success at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Criteria for success at 6 months postoperatively was intraocular pressure (IOP) < 18mmHg without the necessity for adjunctive medication for pressure or IOP < 15mmHg with <=1 adjunctive medication.
- Significant Ocular Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: No ]Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment
|Study Start Date:||April 2008|
|Study Completion Date:||January 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Ranibizumab
Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections
Other Name: Lucentis
No Intervention: Usual care
Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
This is a randomized, open-label, Phase I/II study of intravitreally administered ranibizumab for the treatment of tube patency in glaucoma patients.
Thirty (30) patients with severe glaucoma requiring tubes will be randomized (2:1) to either ranibizumab or observation.
Consented, enrolled subjects assigned to the treatment group will receive open-label intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections Sham intravitreal injections for the observation group will NOT be performed.
Study start date: May 1st, 2007 (estimated) Enrollment period: 6-8 months (estimated) Follow-up period: 6 months Study end Date: December 1st, 2010 (estimated)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644280
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143-0730|
|Study Chair:||Robert Bhisitkul, M.D. , Ph.D.||University of California, San Francisco|
|Study Chair:||Rajen U Desai||Stanford University|
|Study Director:||Patricia Tam||University of California, San Francisco|