Use of Ranibizumab With Mitomycin C During Trabeculectomy (OCTOPUS)
Drug: Ranibizumab and MMC
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Occlusion Prevention for Trabeculectomy Procedures Using Combination Ranibizumab and Mitomycin C (MMC) During Surgery (OCTOPUS Study)|
- Assessment of Ocular Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months
- Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]To determine percent of subjects with a qualified success and viable bleb at 6 months (IOP between 6mm Hg and 22 mm Hg with pressure controlled with and without adjunctive medications)
- Mean Change in in Intraocular Pressure. [ Time Frame: 6 months ] [ Designated as safety issue: No ]Mean change in in intraocular pressure at 3 months and at 6 months
- Mean Change in Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]Mean change in visual acuity in logMAR.
|Study Start Date:||April 2008|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Ranibizumab alone
Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
Experimental: Ranibizumab and MMC
Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Drug: Ranibizumab and MMC
Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
Other Name: Ranibizumab and Mitomycin C
Active Comparator: MMC alone
MMC therapy alone (n=10)
MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.
Other Name: Mitomycin C
A common problem after undergoing trabeculectomy surgery to create a bleb (blister or bubble) to reduce intraocular pressure, is scarring of the opening. This scarring prevents fluid drainage and interferes with the proper functioning of the bleb. MMC (Mitomycin C) is usually administered intraoperatively, to reduce scarring and increase filtration. However, the failure rate of trabeculectomy remains high. Anti-VEGF (Vascular endothelial growth factor) agents have been used successfully in cases requiring bleb needling. The purpose of the study is to determine the safety of the combination of ranibizumab and MMC vs monotherapy MMC in patients with glaucoma.
This is an open-label, Phase I/II safety study of 30 patients randomized to either treatment with ranibizumab 0.5 mg intravitreally injected (n=10), combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10) or MMC therapy alone (n=10).
For the ranibizumab groups, a repeat injection of ranibizumab 0.5mg may be given PRN (as needed) at 1 month if hypervascularity or neovascularization of the conjunctiva exists.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661583
|United States, Colorado|
|Rocky Mountain Lions Eye Institute|
|Aurora, Colorado, United States, 80045|
|Study Director:||Malik Y. Kahook, MD||Rocky Mountain Lions Eye institute|