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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
The purpose of this study is to examine the effects of Lucentis for active Central Retinal Vein Occlusion with Macular Edema
This is an open-label, Phase I study of intravitreally administered ranibizumab in 20 subjects with macular edema associated with CRVO. Patients will be evaluated at baseline with ophthalmic examination, fluorescein angiography, optical coherence tomography, and color photography. Subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered every 28 ± 2 days for a total of 3 injections. Thereafter they are to be evaluated every month until month 12. If the patients have signs of increased intraretinal hemorrhage or a persistence / increase in central macular edema as determined by optical coherence tomography when compared to their last visit, are eligible for re-injection at that monthly visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label ranibizumab | Other | Subjects will receive open-label intravitreal injections of ranibizumab administered every 28 ± 7 days for a total of 3 injections. Thereafter they are to be evaluated monthly for re-treatment until Month 48. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab (Lucentis ) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of Macular Edema associated with CRVO | 72 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3, 6, 12, 24, 36, 48, 60 and 72 | Months 3, 6, 12, 24, 36, 48, 60 and 72 | |
| Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3, 6, 12, 24, 36, 48, 60 and 72. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard F. Spaide, M.D. | Vitreous Retina Macula Consultants of New York, P.C. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitreous Retina Macula Consultants of New York, P.C. | New York | New York | 10022 | United States |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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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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| Months 3, 6, 12, 24, 36, 48, 60 and 72 |
| Change in central retinal thickness as measured by OCT at months 3, 6, 9, 12, 24, 36, 48, 60 and 72 compared to baseline | Months 3, 6, 12, 24, 36, 48, 60 and 72 |
| Proportion of subjects losing ≥ 30 letters as measured by ETDRS visual refraction at month 6, 12, 24, 36, 48, 60 and 72 | Months 6, 12, 24, 36, 48, 60 and 72 |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |