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

Wills Eye63 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma

Interventions

bevacizumabDRUG

1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure

balanced salt solutionOTHER

0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Wills Eye Institute, Glaucoma Service

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Intraocular Pressure (IOP)

mmHg (millimeters of mercury)

Time frame: 6 months

Secondary Outcomes

Number of Participants With Surgical Success

Surgery was rated as complete success, qualified success or failure. Complete success was defined as 20% (percent) reduction in eye pressure (IOP) without any IOP lowering medications. Qualified success was defined as 20% reduction of IOP with IOP lowering medications. Failure was defined as IOP greater than 21 mmHG (millimeters of mercury), less than 20% IOP reduction or need for additional surgery.

Time frame: 6 months

Data from ClinicalTrials.gov

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