Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery
This study has been completed.
Sponsor:
University of California, San Francisco
Collaborator:
Genentech
Information provided by (Responsible Party):
Shan Lin, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00644280
First received: March 24, 2008
Last updated: November 14, 2012
Last verified: November 2012
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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.
| Condition | Intervention |
|---|---|
|
Glaucoma |
Drug: Ranibizumab |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Safety and Efficacy of Ranibizumab in Glaucoma Patients Treated With Filtration Tubes" |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
Drug Information available for:
Ranibizumab
U.S. FDA Resources
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- The primary outcome measure is % of subjects with a tube success at 6 months (IOP of < 22mmHg and no adjunctive meds for pressure) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Ocular adverse events at 6 months including endophthalmitis, rhegmatogenous retinal detachment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | April 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Injection of Ranibizumab pre and post operative.
|
Drug: Ranibizumab
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: 2
Standard of care without injections of Ranibizumab
|
Detailed Description:
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)
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644280
Locations
| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143-0730 | |
Sponsors and Collaborators
University of California, San Francisco
Genentech
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Shan Lin, Professor, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00644280 History of Changes |
| Other Study ID Numbers: | LinLucentis, NIH Grant # FVF4191S |
| Study First Received: | March 24, 2008 |
| Last Updated: | November 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, San Francisco:
|
Glaucoma,Ahmed Valve |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 16, 2013