Bevacizumab Versus Mitomycin C as Trabeculectomy Adjuvant in Uncontrolled Glaucoma

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Refractory glaucoma often requires vision-sparing trabeculectomy. To increase surgical success, adjunctive pharmacotherapy is utilized albeit the risk of adverse events. This prospective trial randomizes adults with uncontrolled glaucoma to assess an emerging healing modulatory strategy. Over a 1-year follow-up, trabeculectomy complemented with intracameral delivery of anti-angiogenic bevacizumab (1.25 mg) is compared to standard trabeculectomy with anti-fibrotic mitomycin-C (0.02%; applied for 2 minutes).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Athens Vision Eye Institute
• Treatments: Antimetabolites; Bevacizumab; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• adult patients

• primary or secondary open angle or angle closure glaucoma

• preoperative intraocular pressure > 21 mmHg on maximally tolerated medical therapy at least on 2 occasions prior to randomization

• ability to attend regular follow-up

Exclusion Criteria:

• age (< 18 years)

• pregnancy

• severe ocular surface disease

• need for combined phacotrabeculectomy

• uveitic or neovascular glaucoma

• any prior intraocular surgery except for uncomplicated phacoemulsification

• a history of a systemic thromboembolic event within 6 months before surgery