Expired Study
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San Francisco, California 94143


Purpose:

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.


Study summary:

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)


Criteria:

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


NCT ID:

NCT00644280


Primary Contact:

Study Chair
Robert Bhisitkul, M.D. , Ph.D.
University of California, San Francisco


Backup Contact:

N/A


Location Contact:

San Francisco, California 94143
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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