Clinical trial NCT00661583: Use of Ranibizumab With Mitomycin C During Trabeculectomy
Official title: Occlusion Prevention for Trabeculectomy Procedures Using Combination Ranibizumab and Mitomycin C (MMC) During Surgery (OCTOPUS Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glaucoma
Keywords: trabeculectomy
glaucoma
ranibizumab
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2008-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Ocular Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months.
timeFrame: 6 months
measure: Mean Change in in Intraocular Pressure.
timeFrame: 6 months
measure: Mean Change in Visual Acuity
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Lions Eye Institute
state: Colorado
Study officials:
affiliation: Rocky Mountain Lions Eye institute
name: Malik Y. Kahook, MD
role: STUDY_DIRECTOR
References:
citation: 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.