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| Name | Class |
|---|---|
| Bay Area Retina Associates | OTHER |
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The primary objective of this proposed research study is to evaluate the safety of intravitreal ranibizumab in combination with intravitreal dexamethasone in comparison to intravitreal ranibizumab alone in the treatment of wet ARMD. The addition of the broad spectrum anti-inflammatory activity of dexamethasone may augment the anti-VEGF activity of ranibizumab by amelioration of inflammation existing in the microenvironment of the choroidal neovascularization. While the anti-VEGF agents have proven to be very efficacious in the treatment of exudative ARMD, their narrow target and window of activity may limit their overall durability of action.
A prospective, single masked comparative trial using either combination therapy (group 1): same day combination therapy with 0.05cc intravitreal dexamethasone injection (10mg/ml vial) and a single 0.5 mg intravitreal ranibizumab injection for four consecutive months will be compared to monotherapy (group 2): one intravitreal injection of 0.5 mg ranibizumab also given for four consecutive months. These treatments will then be followed by PRN treatment based on clinical exam, angiographic studies, and OCT evidence of residual subretinal fluid, CME, subretinal hemorrhage, or pigment epithelial detachment. Fluorescein angiography and fundus photography will be performed at baseline and at the 1, 3, 6, and 12 month follow-up visits. Only OCT testing will be performed at all follow-up visits. Both groups will be re-evaluated for safety at 12 and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy | Experimental | Combination therapy (group 1): same day combination therapy with 0.05cc dose intravitreal dexamethasone injection (10mg/ml vial) and a single 0.5 mg intravitreal ranibizumab injection |
|
| Monotherapy | Active Comparator | intravitreal injection of 0.5 mg ranibizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab and dexamethasone | Drug | Combination therapy (group 1): same day combination therapy with 0.05cc dose intravitreal dexamethasone injection (10mg/ml vial) and a single 0.5 mg intravitreal ranibizumab injection |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of ocular adverse events and visual acuity | 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of treatments required | 12 months |
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Inclusion Criteria:
• Best Corrected Visual Acuity at 4 meters using ETDRS Charts between 20/32 and 20/400 (Snellen Equivalent) in the study eye with evidence of neovascular ARMD.
(Only one eye will be eligible for study. If both eyes are eligible, the one with the better visual acuity will be selected for treatment unless, based on medical reasons, the investigator deems the other eye to be more appropriate for treatment and study.)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Subhransu K Ray, M.D., Ph.D. | Bay Area Retina Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bay Area Retina Associates | Walnut Creek | California | 94598 | United States |
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| Ranibizumab | Drug | intravitreal injection of 0.5 mg ranibizumab |
|
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D003907 | Dexamethasone |
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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