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The purpose of this study is to determine the efficacy in the use of topical Squalamine Lactate Ophthalmic Solution, 0.2% in the treatment of retinal neovascularization resulting from proliferative diabetic retinopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Squalamine | Experimental | Study eyes will be assigned to receive Squalamine. The dose will be one drop twice daily. If neovascularization fails to regress at week one or if neovascularization returns within the study, the dose will be increased to four times daily. In that case, a one day and one week visit will be added after increasing the dose. Patients will continue administering study drug until week 20. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Squalamine Lactate ophthalmic solution 0.2% | Drug | Patients will start with Squalamine one drop twice daily to the affected eye. If at one week the neovascularization shows no sign of regression, then the dose will be doubled to four times daily with a follow up at one day and one week following the increased dose frequency, then resuming the schedule at four weeks. If neovascularization returns within the study, the dose will be doubled to four times daily. In that case, a one day and one week visit will be added after increasing the dose. Squalamine treatment will discontinue after the week 20 visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion with complete regression of neovascularization on fundus photography at one month | 1 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Visual Acuity from Baseline to 5 Months | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion with partial regression of neovascularization on fundus photography | 1 month |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elman Retina Group, P.A. | Baltimore | Maryland | 21237 | United States |
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| ID | Term |
|---|---|
| D015861 | Retinal Neovascularization |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
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|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |