Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery
To determine whether ranibizumab therapy before and after tube insertion for glaucoma surgeries can maintain the patency of the tube and prevent scar formation, and increase the chances for a successful procedure compared to observation.
|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)
|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|