Use of Ranibizumab With Mitomycin C During Trabeculectomy

Phase 1

Completed

• Conditions: Glaucoma
• Interventions: Drug: Ranibizumab and MMC; Drug: Ranibizumab; Drug: MMC

• Registration Number: NCT00661583
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-18
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2016-07-01
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-19
• Last Update Submitted: 2016-08-19
• Results First Posted: 2016-10-13
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab and MMC	Ranibizumab and MMC	Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab alone	Ranibizumab	Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
MMC alone	MMC	MMC therapy alone (n=10)

Primary Outcome Measures

Name	Time	Method
Assessment of Ocular Adverse Events	6 months	To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months

Secondary Outcome Measures

Name	Time	Method
Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months.	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.	6 months	Mean change in in intraocular pressure at 3 months and at 6 months
Mean Change in Visual Acuity	6 months	Mean change in visual acuity in logMAR.

Trial Locations

Locations (1)

Rocky Mountain Lions Eye Institute; 🇺🇸 Aurora, Colorado, United States