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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.
Patients will be followed with spectral oct, 4m BCVA, ICG, FA and monthly eye examinations for one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously Treated | Experimental | With prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial |
|
| Treatment-Naive | Experimental | Treatment-Naive: no previous treatment for PCV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab 2.0mg | Drug | Monthly, intravitreal injection 0.05ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss | To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss, as measured by calculating the mean change in VA from baseline to Month 12 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly | To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly | 1 year |
| To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline F Shen | Contact | (808) 380-8060 | jshen@retinahi.com |
| Name | Affiliation | Role |
|---|---|---|
| Gregg T Kokame, MD, MMM | Retina Consultants of Hawaii | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Hawaii, Inc | Recruiting | Honolulu | Hawaii | 96819 | United States |
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| ID | Term |
|---|---|
| D000092342 | Polypoidal Choroidal Vasculopathy |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D015862 | Choroid Diseases |
| D014603 | Uveal 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 |
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To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss as measured by the following: mean change from baseline in VA at 6 and 12 months, and the proportion of subjects who lose less than 5 letters of vision at Month 6 and Month 12. |
| 1 year |
| To investigate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab on clinical findings associated with PCV | the mean change from baseline at M6 to M12 of subretinal hemorrhage and/or exudates via fundus photographs and fundus exams, decrease and/or complete resolution of branching vascular network from PCV at M3, M6, and M12 as assessed by FA and ICG, decrease and/or complete resolution of the branching vascular network (BVN) from PCV at M3, M6, and M12, as assessed by FA and ICG, mean change in central foveal thickness and/or peripapillary edema as measured by SD-OCT in central and/or paracentral fields from baseline, M3, M6 and M12, incidence of ocular AEs | 1 year |
| Retina Consultants of Hawaii | Recruiting | ‘Aiea | Hawaii | 96701 | United States |
|
| D009389 |
| Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002318 | Cardiovascular Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |