Use of Ranibizumab With Mitomycin C During Trabeculectomy (OCTOPUS)
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|ClinicalTrials.gov Identifier: NCT00661583|
Recruitment Status : Completed
First Posted : April 18, 2008
Results First Posted : October 13, 2016
Last Update Posted : October 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: Ranibizumab Drug: Ranibizumab and MMC Drug: MMC||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Occlusion Prevention for Trabeculectomy Procedures Using Combination Ranibizumab and Mitomycin C (MMC) During Surgery (OCTOPUS Study)|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
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
- Assessment of Ocular Adverse Events [ Time Frame: 6 months ]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 ]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 ]Mean change in in intraocular pressure at 3 months and at 6 months
- Mean Change in Visual Acuity [ Time Frame: 6 months ]Mean change in visual acuity in logMAR.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|