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

Wet Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00139282
• Other study ID #: MSI-1256F-301
• Status: Terminated
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: November 27, 2007
• Start date: June 2005

Study information

• Verified date: November 2007
• Source: Genaera Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Wet Age-Related Macular Degeneration

Intervention

Drug:
• Squalamine Lactate

Locations

Country	Name	City	State
United States	Retina Research Center	Austin	Texas
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Florida Eye Microsurgical Institute	Boynton Beach	Florida
United States	Charlotte Eye, Ear, Nose & Throat Associates	Charlotte	North Carolina
United States	Horizon Eye Care	Charlotte	North Carolina
United States	Carolina Retina Center	Columbia	South Carolina
United States	The Ohio State University, Havener Eye Institute	Columbus	Ohio
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	Cumberland Valley Retina Consultants, PC	Hagerstown	Maryland
United States	Penn State Ophthalmology	Hershey	Pennsylvania
United States	Garcia & Associates, MD, PA	Houston	Texas
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	University of Florida	Jacksonville	Florida
United States	Southeastern Retina Associates	Kingsport	Tennessee
United States	Delaware Valley Retina Associates	Lawrenceville	New Jersey
United States	Virginia Retina Center	Leesburg	Virginia
United States	Eldorado Retina Associates	Louisville	Colorado
United States	MaculaCare	New York	New York
United States	Magruder Eye Institute	Orlando	Florida
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	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	John Moran Eye Center	Salt Lake City	Utah
United States	Retina Associates, PA	Shawnee Mission	Kansas
United States	East Florida Eye Institute	Stuart	Florida
United States	Retina Associates of Florida	Tampa	Florida
United States	Retina Associates of New Jersey	Teaneck	New Jersey
United States	Center for Retina and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genaera Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in area of CNV in the study eye at 52 and 104 weeks compared to baseline, as measured by fluorescein angiography
Secondary	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
Secondary	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.

External Links

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