Use of Ranibizumab With Mitomycin C During Trabeculectomy

Study Overview
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Brief Summary
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The purpose of the study is to study the safety of the combination of ranibizumab and MMC vs monotherapy MMC vs intravitreal ranibizumab injection in patients with glaucoma.

Detailed Description
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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.

Official Title
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Occlusion Prevention for Trabeculectomy Procedures Using Combination Ranibizumab and Mitomycin C (MMC) During Surgery (OCTOPUS Study)

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Ranibizumab
* Drug: Ranibizumab and MMC
* Drug: MMC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: glaucoma undergoing trabeculectomy 21 years of age or older Exclusion Criteria: pregnancy or lactation any condition the investigator believes would impose a significant hazard to the patient if investigational therapy were initiated history of ocular surface disease cataract surgery in the past 6 months history of active inflammatory, infectious or idiopathic keratitis

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranibizumab alone<br>Treatment with ranibizumab 0.5 mg intravitreally injected (n=10) | Drug: Ranibizumab<br>* 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed<br>|
| Experimental: Ranibizumab and MMC<br>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<br>* Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy<br>* Other names: Ranibizumab and Mitomycin C;|
| Active Comparator: MMC alone<br>MMC therapy alone (n=10) | Drug: MMC<br>* MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.<br>* Other names: Mitomycin C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Ocular Adverse Events | To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects With a Qualified Success and Viable Bleb at 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) | 6 months | 
| Mean Change in in Intraocular Pressure. | Mean change in in intraocular pressure at 3 months and at 6 months | 6 months | 
| Mean Change in Visual Acuity | Mean change in visual acuity in logMAR. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trabeculectomy, glaucoma, ranibizumab