Use of Ranibizumab With Mitomycin C During Trabeculectomy

Glaucoma Clinical Trial

— OCTOPUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661583
• Other study ID #: 07-0921
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 15, 2008
• Last updated: April 18, 2016
• Start date: April 2008
• Est. completion date: September 2014

Study information

• Verified date: April 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 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 at 1 month if hypervascularity or neovascularization of the conjunctiva exists.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Ranibizumab
0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
• Ranibizumab and MMC
Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
• MMC
MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.

Locations

Country	Name	City	State
United States	Rocky Mountain Lions Eye Institute	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months		6 months	Yes
Secondary	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	No
Secondary	to determine mean change in in intraocular pressure and in visual acuity at 3 months and at 6 months		6 months	No