Clinical trial NCT00139282: A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: "Wet" Age-Related Macular Degeneration
Keywords: wet AMD
macular degeneration
Lead sponsor: Genaera Corporation
Sponsor class: INDUSTRY
First posted: 2005-08-31
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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:
measure: 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
measure: Change in area of CNV in the study eye at 52 and 104 weeks compared to baseline, as measured by fluorescein angiography
measure: 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
measure: 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.
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Louisville
country: United States
facility: Eldorado Retina Associates
state: Colorado
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Orlando
country: United States
facility: Magruder Eye Institute
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Tampa
country: United States
facility: Retina Associates of Florida
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Shawnee Mission
country: United States
facility: Retina Associates, PA
state: Kansas
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants, PC
state: Maryland
city: Lawrenceville
country: United States
facility: Delaware Valley Retina Associates
state: New Jersey
city: Teaneck
country: United States
facility: Retina Associates of New Jersey
state: New Jersey
city: New York
country: United States
facility: MaculaCare
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose & Throat Associates
state: North Carolina
city: Charlotte
country: United States
facility: Horizon Eye Care
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University, Havener Eye Institute
state: Ohio
city: Hershey
country: United States
facility: Penn State Ophthalmology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Retina Vitreous Consultants
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Genaera Corporation
state: Pennsylvania
city: Columbia
country: United States
facility: Carolina Retina Center
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Kingsport
country: United States
facility: Southeastern Retina Associates
state: Tennessee
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: Houston
country: United States
facility: Garcia & Associates, MD, PA
state: Texas
city: Salt Lake City
country: United States
facility: John Moran Eye Center
state: Utah
city: Leesburg
country: United States
facility: Virginia Retina Center
state: Virginia
Study officials:
References: