A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration
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
1 other identifier
interventional
N/A
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 29, 2005
CompletedFirst Posted
Study publicly available on registry
August 31, 2005
CompletedNovember 28, 2007
November 1, 2007
August 29, 2005
November 27, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Eldorado Retina Associates
Louisville, Colorado, 80027, United States
Florida Eye Microsurgical Institute
Boynton Beach, Florida, 33426, United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912, United States
University of Florida
Jacksonville, Florida, 32256, United States
Magruder Eye Institute
Orlando, Florida, 32803, United States
East Florida Eye Institute
Stuart, Florida, 34994, United States
Retina Associates of Florida
Tampa, Florida, 33609, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, 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
Delaware Valley Retina Associates
Lawrenceville, New Jersey, 08648, United States
Retina Associates of New Jersey
Teaneck, New Jersey, 07666, 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
Penn State Ophthalmology
Hershey, Pennsylvania, 17033, United States
Retina Vitreous Consultants
Pittsburgh, Pennsylvania, 15213, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Genaera Corporation
Plymouth Meeting, Pennsylvania, 19462, 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
Retina Research Center
Austin, Texas, 78705, United States
Garcia & Associates, MD, PA
Houston, Texas, 77002, United States
John Moran Eye Center
Salt Lake City, Utah, 84132, United States
Virginia Retina Center
Leesburg, Virginia, 20176, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 29, 2005
First Posted
August 31, 2005
Study Start
June 1, 2005
Last Updated
November 28, 2007
Record last verified: 2007-11