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

Phase 2

Completed

• Conditions: Glaucoma
• Interventions: Other: balanced salt solution; Drug: bevacizumab

• Registration Number: NCT00853073
• Lead Sponsor: Wills Eye

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Study First Posted: 2009-02-27
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2015-01-30
• Results First Submitted QC: 2015-03-11
• Results First Posted: 2015-03-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-07
• Last Update Posted: 2018-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• require glaucoma bleb needle revision with Mitomycin-C

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
balanced salt solution	balanced salt solution	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.
Bevacizumab	bevacizumab	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.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	6 months	mmHg (millimeters of mercury)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Surgical Success	6 months	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.

Trial Locations

Locations (1)

Wills Eye Institute, Glaucoma Service; 🇺🇸 Philadelphia, Pennsylvania, United States