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