Does Adding Bevacizumab Therapy in Glaucoma Surgery Improve the Success of Needle Bleb Revisions? (Avastin)

Wills Eye

Status and phase: Completed; Phase 3; Phase 2

Conditions: Glaucoma

Treatments: Other: balanced salt solution; Drug: bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00853073

08-867

Details and patient eligibility

About

The purpose of this study is to see if a new add on (or adjunctive) therapy used in glaucoma surgery improves the success of needle bleb revisions.

Full description

To investigate the efficacy of needle bleb revisions with mitomycin C with subconjunctival bevacizumab in promoting both filtering success and favorable bleb morphologic features.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• require glaucoma bleb needle revision with Mitomycin-C

Exclusion criteria

• pregnant, nursing, or not using adequate contraception
• other glaucoma eye surgery involving tube shunts
• prior retinal detachments surgery with scleral buckle
• infection, inflammation, or any abnormality preventing eye pressure measurement
• enrolled in another investigational study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups, including a placebo group

Bevacizumab

Active Comparator group

Description:

subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.

Treatment:

Drug: bevacizumab

balanced salt solution

Placebo Comparator group

Description:

patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.

Treatment:

Other: balanced salt solution