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

Phase 3

Terminated

• 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

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-31
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-27
• Last Update Posted: 2007-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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

• 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

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

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