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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 legal 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 test the safety and efficacy of Squalamine in the treatment of AMD.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSI-1256F (Squalamine Lactate) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by optical coherence tomography | ||
| To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by fluorescein angiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randy Katz, MD | Florida Eye Microsurgical Institute, Inc. | Principal Investigator |
| Alexander Eaton, MD | Retina Health Center | Principal Investigator |
| Thomas Ciulla, MD | Midwest Eye Institute | Principal Investigator |
| Raymond Sjaarda, MD | Retina Specialists | Principal Investigator |
| Nelson Sabates, MD | Eye Foundation of Kansas City | Principal Investigator |
| Charles Garcia, MD | Charles Garcia, MD, P.A. | Principal Investigator |
| Glenn Stoller, MD | Ophthalmic Consultants of Long Island | Principal Investigator |
| Phillip Rosenfeld, MD | Bascom Palmer Eye Institute | Principal Investigator |
| Steven Rose, MD | Retina Associates of Western New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Eye Microsurgical Institute | Boynton Beach | Florida | 33426 | United States | ||
| Retina Health Center |
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| Fort Meyers |
| Florida |
| 33907 |
| United States |
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46280 | United States |
| Retina Specialists | Towson | Maryland | 21204 | United States |
| Eye Foundation of Kansas City | Kansas City | Missouri | 64108 | United States |
| Ophthalmic Consultants of Long Island | Long Island City | New York | 11563 | United States |
| Retina Associates of Western New York | Rochester | New York | 14618 | United States |
| Charles Garcia, MD, P.A. | Houston | Texas | 77002 | 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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