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Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of blindness among adults age 50 or older in the Western world. AMD presents in two different types: "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will evaluate the safety and efficacy of Squalamine lactate in the treatment of AMD in patients, the exact number of which will be determined based on data from the sponsor's ongoing Phase 2 trials.
The trial objective is to evaluate the safety and efficacy of two doses of Squalamine lactate for Injection administered as intravenous infusions weekly for 4 weeks followed by maintenance doses every 4 weeks through week 104 compared with the safety and efficacy in the control group.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Squalamine Lactate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Loss in best corrected visual acuity (BCVA) of greater than or equal to 15 letters (ETDRS) at 52 weeks in the study eye compared to baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in retinal thickness in the study eye at 52 and 104 weeks compared to baseline, as measured by OCT, in a subset of subjects | ||
| Change in area of CNV in the study eye at 52 and 104 weeks compared to baseline, as measured by fluorescein angiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States | ||
| Eldorado Retina Associates |
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| Gain or loss in BCVA of greater than or equal to 15 letters (ETDRS) at 52 and 104 weeks in the fellow eye compared to baseline in the subgroup of subjects whose fellow eye is affected with wet AMD |
| Loss in binocular visual acuity of greater than or equal to 15 letters at 52 and 104 weeks compared to baseline, using a modified ETDRS protocol. |
| Louisville |
| Colorado |
| 80027 |
| United States |
| Florida Eye Microsurgical Institute | Boynton Beach | Florida | 33426 | United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| University of Florida | Jacksonville | Florida | 32256 | United States |
| Magruder Eye Institute | Orlando | Florida | 32803 | United States |
| East Florida Eye Institute | Stuart | Florida | 34994 | United States |
| Retina Associates of Florida | Tampa | Florida | 33609 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46280 | United States |
| Retina Associates, PA | Shawnee Mission | Kansas | 66204 | United States |
| Cumberland Valley Retina Consultants, PC | Hagerstown | Maryland | 21740 | United States |
| Delaware Valley Retina Associates | Lawrenceville | New Jersey | 08648 | United States |
| Retina Associates of New Jersey | Teaneck | New Jersey | 07666 | United States |
| MaculaCare | New York | New York | 10021 | United States |
| Charlotte Eye, Ear, Nose & Throat Associates | Charlotte | North Carolina | 28210 | United States |
| Horizon Eye Care | Charlotte | North Carolina | 28211 | United States |
| The Ohio State University, Havener Eye Institute | Columbus | Ohio | 43210 | United States |
| Penn State Ophthalmology | Hershey | Pennsylvania | 17033 | United States |
| Retina Vitreous Consultants | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Genaera Corporation | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Carolina Retina Center | Columbia | South Carolina | 29223 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Southeastern Retina Associates | Kingsport | Tennessee | 37660 | United States |
| Retina Research Center | Austin | Texas | 78705 | United States |
| Garcia & Associates, MD, PA | Houston | Texas | 77002 | United States |
| John Moran Eye Center | Salt Lake City | Utah | 84132 | United States |
| Virginia Retina Center | Leesburg | Virginia | 20176 | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C488568 | squalamine lactate |
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