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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The object of the study is to compare treatment of iris/angle neovascularization with panretinal photocoagulation (laser) to treatment with panretinal photocoagulation and an anti-angiogenic drug: ranibizumab.
A.To obtain preliminary data on the safety and tolerability of ranibizumab (0.5 mg)in patients with new or progressive neovascularization of the iris or angle due to retinal ischemic diseases in addition to treatment with PRP using the incidence and severity of adverse events identified by subjenc reporting vital signs, and ocular examition.
B.To assess the proportion of patients who fail to experience regression of iris and angle neovascularization documented by the clinical examination, iris florescein angiography and gonioscopic evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Panretinal Photocoagulation |
|
| 2 | Active Comparator | Ranibizumab Supplementing Panretinal Laser Photocoagulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panretinal Photocoagulation | Procedure | Panretinal Photocoagulation treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events identified by subject reporting, vital signs, and ocular exam. | 1 to 12 months | |
| The proportion of patients who fail to maintain regression of iris and angle neovascularization documented by the clinical examination iris fluorescein angiography and gonioscopic evaluation. | 1 to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change in best corrected visual acuity score | 1 to 12 months | |
| The percentage/number of patients that experience vision loss of 30 letters or less | 1 to 12 months | |
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Inclusion Criteria:
All subjects must meet the following criteria to be eligible for study entry:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magdalena G Krzystolik, MD | Southern New England Retina Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern New England Retina Associates | Providence | Rhode Island | 02904 | United States |
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| Panretinal Photocoagulation and intravitreal injection of ranibizumab |
| Procedure |
Panretinal photocoagulation and ranibizumab |
|
|
| The percentage number of patients that experience vision improvement of more than 15 letters |
| 1 to 12 months |
| The percentage/number of patients whose vision progressed to no light perception | 1 to 12 months |
| The mean change in macular thickness on OCT | 1 to 12 months |
| The percentage/number of eyes that will require surgical intervention to maintain the intraocular pressure or useful vision | 1 to 12 months |
| The percentage/ number of eyes that will require anti-glaucoma medications to control intraocular pressure | 1 to 12 months |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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