A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration

Stopped early · Phase 3

Conditions studied: "Wet" Age-Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00139282

Run by

Genaera Corporation

Starts

2005-06-01

Last updated by the study team

2007-11-28

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a diagnosis of "wet" age-related macular degeneration

You may not qualify if…

• Prior treatment for "wet" age-related macular degeneration in the affected eye in the past 3 months

Where it is running

• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• Eldorado Retina Associates — Louisville, Colorado, United States
• Florida Eye Microsurgical Institute — Boynton Beach, Florida, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• University of Florida — Jacksonville, Florida, United States
• Magruder Eye Institute — Orlando, Florida, United States
• East Florida Eye Institute — Stuart, Florida, United States
• Retina Associates of Florida — Tampa, Florida, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• Retina Associates, PA — Shawnee Mission, Kansas, United States
• Cumberland Valley Retina Consultants, PC — Hagerstown, Maryland, United States
• Delaware Valley Retina Associates — Lawrenceville, New Jersey, 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
• Penn State Ophthalmology — Hershey, Pennsylvania, United States
• Retina Vitreous Consultants — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Genaera Corporation — Plymouth Meeting, Pennsylvania, United States
• Carolina Retina Center — Columbia, South Carolina, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States
• Southeastern Retina Associates — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.