Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab
Trabeculectomy with mitomycin C remains the standard surgery for glaucoma. This surgery involves creating a door in the eye wall in order to improve fluid outflow and decrease intraocular pressure. However, success rates range from 70% to 90% depending on the criteria used and tend to decrease with time. The failure of the surgery is associated with inflammation, new blood vessel formation and scarring which can cause closure of the door. Molecules which inhibit new blood vessel formation such as inhibitors of vascular endothelial growth factor have been used successfully to decrease scarring in animal eyes where little doors were created and significantly improve survival. Furthermore, they have shown promise when used during trabeculectomy. Ranibizumab, a vascular endothelial growth factor, has also been used safely in intraocular surgery to treat other diseases which involve new blood vessel formation such as macular degeneration and diabetes.
The investigators hypothesize that ranibizumab may decrease the failure rate of trabeculectomy with mitomycin C by decreasing scarring.
The aim of the study is to evaluate the difference in failure rates and bleb morphology at one year post-operatively in eyes having undergone sub-conjunctival injections of ranibizumab in addition to primary trabeculectomy with mitomycin C compared to eyes having undergone trabeculectomy with mitomycin C alone.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab|
- Failure rates of the surgery as defined by intraocular pressure reductions [ Time Frame: one year ] [ Designated as safety issue: No ]Complete success: post-operative IOP between 5-18 mm Hg and at least a 20% reduction in IOP from baseline without the use of glaucoma medications. Qualified success: similar definition with the use of glaucoma medications.
- Bleb morphology using Moorfields bleb grading system [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||March 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Trabeculectomy with mitomycin C associated with 2 subconjunctival injections of ranibizumab: 1 intraoperatively and 1 at 2 weeks post-operatively
Two ranibizumab subconjunctival injections (0.5 mg ∕ 0.05 mL). The first injection at the end of the surgery (intraoperative) and the second two weeks post-operatively.
Active Comparator: standard care
Trabeculectomy with mitomycin C and standard post-operative care
Procedure: standard care
standard post-operative care after trabeculectomy with mitomycin C
Prospective, randomized, unblinded clinical trial. Two groups of patients with glaucoma undergoing primary trabeculectomy or phaco-trabeculectomy with MMC between March 2009 and September 2012. The ranibizumab group (RAN) received 2 subconjunctival injections of 0.5 mg of ranibizumab (intraoperatively and on day 14) and he control group did not receive ranibizumab.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892398
|Montreal, Quebec, Canada, H1T2M4|
|Principal Investigator:||Gisele Li, M.D.||Maisonneuve-Rosemont Hospital|