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

Sponsor:	Genaera Corporation
Information provided by:	Genaera Corporation
ClinicalTrials.gov Identifier:	NCT00139282

Purpose

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.

Condition	Intervention	Phase
"Wet" Age-Related Macular Degeneration	Drug: Squalamine Lactate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Lactic acid Squalamine Squalamine lactate Ammonium lactate

U.S. FDA Resources

Further study details as provided by Genaera Corporation:

Primary Outcome Measures:

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:

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.

Study Start Date:

June 2005

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139282

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Locations

United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
United States, Colorado
Eldorado Retina Associates
Louisville, Colorado, United States, 80027
United States, Florida
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
Florida Eye Microsurgical Institute
Boynton Beach, Florida, United States, 33426
Magruder Eye Institute
Orlando, Florida, United States, 32803
East Florida Eye Institute
Stuart, Florida, United States, 34994
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
University of Florida
Jacksonville, Florida, United States, 32256
Retina Associates of Florida
Tampa, Florida, United States, 33609
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46280
United States, Kansas
Retina Associates, PA
Shawnee Mission, Kansas, United States, 66204
United States, Maryland
Cumberland Valley Retina Consultants, PC
Hagerstown, Maryland, United States, 21740
United States, New Jersey
Retina Associates of New Jersey
Teaneck, New Jersey, United States, 07666
Delaware Valley Retina Associates
Lawrenceville, New Jersey, United States, 08648
United States, New York
MaculaCare
New York, New York, United States, 10021
United States, North Carolina
Charlotte Eye, Ear, Nose & Throat Associates
Charlotte, North Carolina, United States, 28210
Horizon Eye Care
Charlotte, North Carolina, United States, 28211
United States, Ohio
The Ohio State University, Havener Eye Institute
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Retina Vitreous Consultants
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Penn State Ophthalmology
Hershey, Pennsylvania, United States, 17033
Genaera Corporation
Plymouth Meeting, Pennsylvania, United States, 19462
United States, South Carolina
Carolina Retina Center
Columbia, South Carolina, United States, 29223
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Southeastern Retina Associates
Kingsport, Tennessee, United States, 37660
United States, Texas
Garcia & Associates, MD, PA
Houston, Texas, United States, 77002
Retina Research Center
Austin, Texas, United States, 78705
United States, Utah
John Moran Eye Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
Virginia Retina Center
Leesburg, Virginia, United States, 20176

Sponsors and Collaborators

Genaera Corporation

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	MSI-1256F-301
Study First Received:	August 29, 2005
Last Updated:	November 27, 2007
ClinicalTrials.gov Identifier:	NCT00139282 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genaera Corporation:

wet AMD
macular degeneration

Additional relevant MeSH terms:

Anticarcinogenic Agents
Squalamine
Anti-Infective Agents
Uveal Diseases
Antineoplastic Agents
Growth Substances
Eye Diseases
Physiological Effects of Drugs
Choroid Diseases
Macular Degeneration
Retinal Degeneration
Angiogenesis Inhibitors

Protective Agents
Pharmacologic Actions
Choroidal Neovascularization
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Metaplasia
Growth Inhibitors
Angiogenesis Modulating Agents
Neovascularization, Pathologic
Retinal Diseases

ClinicalTrials.gov processed this record on November 27, 2009