Subconjunctival Bevacizumab to Prevent Bleb Failure After Glaucoma Filtration Surgery

• Status: Unknown status
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study analyzes the safety and efficacy of off-label Subconjunctival Injection of bevacizumab (Avastin) versus 0.02% mitomycin C (MMC) for preventing bleb failure following glaucoma filtration surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grewal Eye Institute
• Treatments: Bevacizumab; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

1. Age 40 years or over.

2. Patient with uncontrolled intraocular pressure on maximum tolerated medical therapy (both primary open angle and primary angle closure glaucoma), requiring trabeculectomy.

3. Indications for surgery are based on our own practice patterns: (1) IOP values that are associated with high probability of glaucoma progression and (2) deterioration of the visual field or changes of the optic disk that is compatible with progressive glaucomatous damage, as judged by the examining physician.

4. No history of prior surgical procedure like trabeculectomy, cataract surgery, posterior segment surgery etc.

5. Subject able and willing to cooperate with investigation plan.

6. Subject able and willing to complete postoperative follow-up requirements.

7. Subject willing to sign informed consent form.

Exclusion Criteria:

1. Known allergic reaction to mitomycin-C/ bevacizumab.

2. Subject is on warfarin and discontinuation is not recommended.

3. Normal tension glaucoma.

4. Participation in an investigational study during the 30 days preceding trabeculectomy

5. Patients who had undergone major surgery utpo 28 days before.

6. Ocular infection within 14 days prior to trabeculectomy.

7. Pregnant or breast-feeding women.

8. Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications