A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration
- Conditions
- "Wet" Age-Related Macular Degeneration
- Registration Number
- NCT00139282
- Lead Sponsor
- Genaera Corporation
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
- Patients with a diagnosis of "wet" age-related macular degeneration
- Prior treatment for "wet" age-related macular degeneration in the affected eye in the past 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (29)
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Penn State Ophthalmology
🇺🇸Hershey, Pennsylvania, United States
Retina Associates, PA
🇺🇸Shawnee Mission, Kansas, United States
Virginia Retina Center
🇺🇸Leesburg, Virginia, United States
Retina Research Center
🇺🇸Austin, Texas, United States
Genaera Corporation
🇺🇸Plymouth Meeting, Pennsylvania, United States
Eldorado Retina Associates
🇺🇸Louisville, Colorado, United States
Midwest Eye Institute
🇺🇸Indianapolis, Indiana, United States
Cumberland Valley Retina Consultants, PC
🇺🇸Hagerstown, Maryland, United States
Retina Vitreous Consultants
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Southeastern Retina Associates
🇺🇸Kingsport, Tennessee, United States
Garcia & Associates, MD, PA
🇺🇸Houston, Texas, United States
John Moran Eye Center
🇺🇸Salt Lake City, Utah, United States
Retina Associates of Florida
🇺🇸Tampa, Florida, United States
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Retina Associates of New Jersey
🇺🇸Teaneck, New Jersey, United States
MaculaCare
🇺🇸New York, New York, United States
Charlotte Eye, Ear, Nose & Throat Associates
🇺🇸Charlotte, North Carolina, United States
Horizon Eye Care
🇺🇸Charlotte, North Carolina, United States
The Ohio State University, Havener Eye Institute
🇺🇸Columbus, Ohio, United States
University of Florida
🇺🇸Jacksonville, Florida, United States
East Florida Eye Institute
🇺🇸Stuart, Florida, United States
Delaware Valley Retina Associates
🇺🇸Lawrenceville, New Jersey, United States
Florida Eye Microsurgical Institute
🇺🇸Boynton Beach, Florida, United States
Carolina Retina Center
🇺🇸Columbia, South Carolina, United States
Magruder Eye Institute
🇺🇸Orlando, Florida, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States