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To establish the tolerability and preliminary efficacy of Cand5 by a single intravitreal injection in patients with wet age-related macular degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 0.1 mg bevasiranib in the study eye |
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| 2 | Experimental | 0.33 mg bevasiranib in the study eye, |
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| 3 | Experimental | 1.0 mg bevasiranib in the study eye |
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| 4 | Experimental | 1.5 mg bevasiranib in the study eye |
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| 5 | Experimental | 3.0 mg bevasiranib in the study eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevasiranib | Drug |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Complications, including those related to the intravitreal injection, and adverse events, and loss of lines of best-corrected visual acuity, slit lamp findings, lens opacification, intraocular pressure, fundus findings, and laboratory findings. |
| Measure | Description | Time Frame |
|---|---|---|
| Stabilization of visual acuity (prevention of loss of three or more lines on the ETDRS chart), stabilization of lesion size, lack of leakage of lesion, or decrease in subretinal fluid |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OPKO site | Morristown | New Jersey | United States |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C554088 | bevasiranib |
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| bevasiranib |
| Drug |
The first three patients enrolled will receive 0.1 mg Cand5 in the study eye, the next three patients enrolled will receive 0.33 mg Cand5 in the study eye, the following three patients enrolled will receive 1.0 mg Cand5 in the study eye, the following three patients enrolled will receive 1.5 mg Cand5 in the study eye, and the remaining three patients enrolled will receive 3.0 mg Cand5 in the study eye. The third patient enrolled at each dose level will complete their two-week visit before the next dose level group may be treated. |
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