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

Study Overview
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Brief Summary
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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.

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

Official Title
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Does a New Add on (or Adjunctive) Therapy Used in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: bevacizumab
* Other: balanced salt solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bevacizumab<br>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. | Drug: bevacizumab<br>* 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure<br>* Other names: Avastin;|
| Placebo Comparator: balanced salt solution<br>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. | Other: balanced salt solution<br>* 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | mmHg (millimeters of mercury) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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failing blebs, failing express shunt, avastin, bevacizumab, glaucoma, prior trabeculectomy, Express shunt placed under a scleral flap, subsequent filtration failure