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| ID | Type | Description | Link |
|---|---|---|---|
| NIH Grant # FVF4191S |
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low recruitment
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Active Comparator | 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 |
|
| Usual care | No Intervention | Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Significant Ocular Adverse Events | Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bhisitkul, M.D., Ph.D. | University of California, San Francisco | Study Chair |
| Rajen U Desai | Stanford University | Study Chair |
| Patricia Tam | University of California, San Francisco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143-0730 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22712537 | Result | Desai RU, Singh K, Lin SC. Intravitreal ranibizumab as an adjunct for Ahmed valve surgery in open-angle glaucoma: a pilot study. Clin Exp Ophthalmol. 2013 Mar;41(2):155-8. doi: 10.1111/j.1442-9071.2012.02836.x. Epub 2012 Sep 4. |
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Patients were recruited from the University of California, San Francisco (UCSF) Glaucoma Service
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Usual Care | Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participants | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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IOP reduction may be attributable to cataract surgery instead of or in addition to ranibizumab use. Further studies, with larger sample size and longer follow-up, are needed to evaluate safety and potential efficacy of intravitreal ranibizumab.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shan C. Lin, MD | University of California San Francisco | 415-353-2608 | lins@vision.ucsf.edu |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Significant Ocular Adverse Events | Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment | Posted | Number | participants | 6 months |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Usual Care | Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab | 0 | 5 | 0 | 5 |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |