Use of Ranibizumab With Mitomycin C During Trabeculectomy

Phase 1/2 Completed 30 enrolled University of Colorado, Denver Genentech, Inc. · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2008-04
Primary completion: 2014-09
Completion: 2014-09

Outcome

Met primary endpoint

paper There were statistically significant differences in peripheral bleb area (P = .02), peripheral bleb vascularity (P = .02), PMID 20570237 ↗

paper with Group B exhibiting more diffuse blebs with a lower degree of vascularity. PMID 20570237 ↗

Publications

Kahook MY. Bleb morphology and vascularity after trabeculectomy with intravitreal ranibizumab: a pilot study. Am J Ophthalmol. 2010 Sep;150(3):399-403.e1. doi: 10.1016/j.ajo.2010.03.025. Epub 2010 Jun 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	MMC	Unknown	0.4 mg/ml	Topical
Subject	Ranibizumab	Monoclonal antibody	0.5 mg	Intravitreal