Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery
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|ClinicalTrials.gov Identifier: NCT00644280|
Recruitment Status : Terminated (low recruitment)
First Posted : March 26, 2008
Results First Posted : July 26, 2013
Last Update Posted : July 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: Ranibizumab||Not Applicable|
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 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 (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Safety and Efficacy of Ranibizumab in Glaucoma Patients Treated With Filtration Tubes"|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||January 2011|
Active Comparator: Ranibizumab
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
intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections
Other Name: Lucentis
No Intervention: Usual care
Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
- Tube Success at 6 Months [ Time Frame: 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.
- Significant Ocular Adverse Events [ Time Frame: 6 months ]Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644280
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143-0730|
|Study Chair:||Robert Bhisitkul, M.D. , Ph.D.||University of California, San Francisco|
|Study Chair:||Rajen U Desai||Stanford University|
|Study Director:||Patricia Tam||University of California, San Francisco|