A Study of MSI-1256F (Squalamine Lactate) To Treat "Wet" Age-Related Macular Degeneration
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
- To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate []
Secondary Outcome Measures
- 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 []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult subjects ≥ 50 years of age.
-
minimally classic or active occult choroidal neovascularization associated with age-related macular degeneration in one or both eyes.
-
baseline best corrected visual acuity score between 35 to 65 letters according to the Early Treatment of Diabetic Retinopathy Study protocol.
-
central retinal thickness by optical coherence tomography of > 250 microns.
-
lesions > 9 disc areas.
-
25% fibrosis in the lesion.
Exclusion Criteria:
-
Previous history of triamcinolone, bevacizumab, ranibizumab, or pegaptanib sodium injection therapy in the study eye.
-
retinal or optic nerve disease.
-
uncontrolled diabetes.
-
ongoing malignancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida Eye Microsurgical Institute | Boynton Beach | Florida | United States | 33426 |
| 2 | Retina Health Center | Fort Meyers | Florida | United States | 33907 |
| 3 | Bascom Palmer Eye Institute | Miami | Florida | United States | 33136 |
| 4 | Midwest Eye Institute | Indianapolis | Indiana | United States | 46280 |
| 5 | Retina Specialists | Towson | Maryland | United States | 21204 |
| 6 | Eye Foundation of Kansas City | Kansas City | Missouri | United States | 64108 |
| 7 | Ophthalmic Consultants of Long Island | Long Island | New York | United States | 11563 |
| 8 | Retina Associates of Western New York | Rochester | New York | United States | 14618 |
| 9 | Charles Garcia, MD, P.A. | Houston | Texas | United States | 77002 |
Sponsors and Collaborators
- Genaera Corporation
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MSI-1256F-212