Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

Study Overview
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Brief Summary
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To determine whether ranibizumab therapy before and after tube insertion for glaucoma surgeries can maintain the patency of the tube and prevent scar formation, and increase the chances for a successful procedure compared to observation.

Detailed Description
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This is a randomized, open-label, Phase I/II study of intravitreally administered ranibizumab for the treatment of tube patency in glaucoma patients. Thirty (30) patients with severe glaucoma requiring tubes will be randomized (2:1) to either ranibizumab or observation. Consented, enrolled subjects assigned to the treatment group will receive open-label intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections Sham intravitreal injections for the observation group will NOT be performed. Study periods: Study start date: May 1st, 2007 (estimated) Enrollment period: 6-8 months (estimated) Follow-up period: 6 months Study end Date: December 1st, 2010 (estimated)

Official Title
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Evaluation of Safety and Efficacy of Ranibizumab in Glaucoma Patients Treated With Filtration Tubes

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ability to provide written informed consent and comply with study assessment for the full duration of the study. age ≥ 21 diagnosis of glaucoma and determined to be candidate for therapy with tube insertion. Exclusion Criteria: pregnant or lactating females Persons on oral contraceptives and women of child-bearing age prior enrollment in the study any conditions the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated participation in another simultaneous medical investigation or trial history of active inflammatory, infectious, or idiopathic keratitis precluding view of anterior segment structures previous injections of ranibizumab in either eye. Persons on Plavix (clopidogrel bisulfate) and coumadin Persons with uncontrolled high blood pressure Persons with renal or liver disease

Ages Eligible for Study
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Minimum Age: 21 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: Ranibizumab<br>Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery | Drug: Ranibizumab<br>* intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections<br>* Other names: Lucentis;|
| No Intervention: Usual care<br>Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tube Success at 6 Months | Criteria for success at 6 months postoperatively was intraocular pressure (IOP) < 18mmHg without the necessity for adjunctive medication for pressure or IOP < 15mmHg with <=1 adjunctive medication. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant Ocular Adverse Events | Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma,Ahmed Valve