Use of Ranibizumab With Mitomycin C During Trabeculectomy (OCTOPUS)

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glaucoma

Treatments: Drug: MMC; Drug: Ranibizumab; Drug: Ranibizumab and MMC

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00661583

07-0921

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

Ranibizumab alone

Experimental group

Description:

Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)

Treatment:

Drug: Ranibizumab

Ranibizumab and MMC

Experimental group

Description:

Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)

Treatment:

Drug: Ranibizumab and MMC

MMC alone

Active Comparator group

Description:

MMC therapy alone (n=10)

Treatment:

Drug: MMC