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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
The primary objective of this study is to determine the safety & efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration.
This study will be a phase I/II open label interventional case series. Twenty patients with retinal angiomatous proliferation will be randomized to receive intravitreal ranibizumab at a dose of 0.3mg/0.05 ml or 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 12 months. Patients will be followed for a complete 12-month treatment course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Lucentis 0.3mg/0.05 ml |
|
| 2 | Active Comparator | Lucentis 0.5mg/0.05 ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucentis | Drug | 0.3mg/0.05 ml or 0.5mg/0.05 ml |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters | 2 years | |
| Proportion of subjects who gain at least 15 letters in the best corrected visual acuity score at 6 and 12 months compared to baseline | 12 months | |
| Incidence and severity of ocular adverse events | 12 months | |
| Incidence and severity of non-ocular adverse events | 12 months | |
| Changes in vital signs | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the systemic and local safety of ranibizumab (0.3mg or 0.5mg) in patients with RAP lesions | 12 months | |
| Assess the impact of ranibizumab (0.3mg or 0.5mg) on time to improvement in retinal thickness by OCT | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas M Johnson, MD | National Retina Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Retina Institute | Chevy Chase | Maryland | 20815 | United States | ||
| National Retina Institute |
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| Ranibizumab | Drug | 0.3mg/0.05 ml or 0.5mg/0.05 ml |
|
|
| Ranibizumab (Lucentis) | Drug | 0.3mg/0.05 ml intravitreally |
|
|
| Ranibizumab (Lucentis) | Drug | 0.5mg/0.05 ml |
|
|
| Assess the impact of ranibizumab (0.3mg or 0.5 mg) on leakage from RAP lesions by Fluorescein angiography | 2 years |
| Static / high speed ICG appearance to assess the impact of ranibizumab (0.3mg or 0.5mg) on persistence / recurrence of RAP lesion and monitor for development of retinal-choroidal anastomoses | 2 years |
| Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of retinal-choroidal anastomoses as determined on clinical examination and high speed ICG | 2 years |
| Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of subretinal fibrosis as determined by clinical examination | 2 years |
| Towson |
| Maryland |
| 21204 |
| United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| 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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