Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

University of California, San Francisco11 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma

Interventions

RanibizumabDRUG

intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ability to provide written informed consent and comply with study assessment for the full duration of the study. 2. age ≥ 21 3. diagnosis of glaucoma and determined to be candidate for therapy with tube insertion. Exclusion Criteria: 1. pregnant or lactating females 2. Persons on oral contraceptives and women of child-bearing age 3. prior enrollment in the study 4. any conditions the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated 5. participation in another simultaneous medical investigation or trial 6. history of active inflammatory, infectious, or idiopathic keratitis precluding view of anterior segment structures 7. previous injections of ranibizumab in either eye. 8. Persons on Plavix (clopidogrel bisulfate) and coumadin 9. Persons with uncontrolled high blood pressure 10. Persons with renal or liver disease

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Significant Ocular Adverse Events

Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment

Time frame: 6 months

Data from ClinicalTrials.gov

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