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

Condition(s) targeted: "Wet" Age-Related Macular Degeneration

Intervention: Squalamine Lactate (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Genaera Corporation

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.

Official title: A Phase 3, Multicenter, Randomized, Double-Masked, Controlled Study of Squalamine Lactate (MSI-1256F) for Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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:

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.

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- Prior treatment for "wet" age-related macular degeneration in the affected eye in the

past 3 months

Retina-Vitreous Associates Medical Group, Beverly Hills, California 90211, United States

Eldorado Retina Associates, Louisville, Colorado 80027, United States

National Ophthalmic Research Institute, Fort Myers, Florida 33912, United States

Center for Retina and Macular Disease, Winter Haven, Florida 33880, United States

Magruder Eye Institute, Orlando, Florida 32803, United States

East Florida Eye Institute, Stuart, Florida 34994, United States

Florida Eye Microsurgical Institute, Boynton Beach, Florida 33426, United States

University of Florida, Jacksonville, Florida 32256, United States

Retina Associates of Florida, Tampa, Florida 33609, 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

Retina Associates of New Jersey, Teaneck, New Jersey 07666, United States

Delaware Valley Retina Associates, Lawrenceville, New Jersey 08648, 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

Genaera Corporation, Plymouth Meeting, Pennsylvania 19462, United States

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States

Penn State Ophthalmology, Hershey, Pennsylvania 17033, United States

Retina Vitreous Consultants, Pittsburgh, Pennsylvania 15213, 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

Garcia & Associates, MD, PA, Houston, Texas 77002, United States

Retina Research Center, Austin, Texas 78705, United States

John Moran Eye Center, Salt Lake City, Utah 84132, United States

Virginia Retina Center, Leesburg, Virginia 20176, United States

Starting date: June 2005
Last updated: November 27, 2007