A Study of MSI-1256F (Squalamine Lactate) To Treat "Wet" Age-Related Macular Degeneration - Full Text View

Sponsored by:	Genaera Corporation
Information provided by:	Genaera Corporation
ClinicalTrials.gov Identifier:	NCT00333476

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 legal 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 test the safety and efficacy of Squalamine in the treatment of AMD.

Condition	Intervention	Phase
Macular Degeneration	Drug: MSI-1256F (Squalamine Lactate)	Phase II

Study Type:	Interventional
Study Design:	Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Randomized, Open Label, Safety, and Pharmacodynamic Study of Squalamine Lactate for Injection for the Treatment of Minimally Classic or Active Occult 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:

To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate

Secondary Outcome Measures:

To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by optical coherence tomography
To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by fluorescein angiography

Estimated Enrollment:	140
Study Start Date:	May 2006

Eligibility

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

Criteria

Inclusion Criteria:

Adult subjects ≥ 50 years of age.
minimally classic or active occult choroidal neovascularization associated with age-related macular degeneration in one or both eyes.
baseline best corrected visual acuity score between 35 to 65 letters according to the Early Treatment of Diabetic Retinopathy Study protocol.
central retinal thickness by optical coherence tomography of > 250 microns.
lesions > 9 disc areas.
> 25% fibrosis in the lesion.

Exclusion Criteria:

Previous history of triamcinolone, bevacizumab, ranibizumab, or pegaptanib sodium injection therapy in the study eye.
retinal or optic nerve disease.
uncontrolled diabetes.
ongoing malignancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333476

Locations

United States, Florida
Florida Eye Microsurgical Institute
Boynton Beach, Florida, United States, 33426
Retina Health Center
Fort Meyers, Florida, United States, 33907
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46280
United States, Maryland
Retina Specialists
Towson, Maryland, United States, 21204
United States, Missouri
Eye Foundation of Kansas City
Kansas City, Missouri, United States, 64108
United States, New York
Ophthalmic Consultants of Long Island
Long Island, New York, United States, 11563
Retina Associates of Western New York
Rochester, New York, United States, 14618
United States, Texas
Charles Garcia, MD, P.A.
Houston, Texas, United States, 77002

Sponsors and Collaborators

Genaera Corporation

Investigators

Principal Investigator:	Randy Katz, MD	Florida Eye Microsurgical Institute, Inc.
Principal Investigator:	Alexander Eaton, MD	Retina Health Center
Principal Investigator:	Thomas Ciulla, MD	Midwest Eye Institute
Principal Investigator:	Raymond Sjaarda, MD	Retina Specialists
Principal Investigator:	Nelson Sabates, MD	Eye Foundation of Kansas City
Principal Investigator:	Charles Garcia, MD	Charles Garcia, MD, P.A.
Principal Investigator:	Glenn Stoller, MD	Ophthalmic Consultants of Long Island
Principal Investigator:	Phillip Rosenfeld, MD	Bascom Palmer Eye Institute
Principal Investigator:	Steven Rose, MD	Retina Associates of Western New York

More Information

No publications provided

Study ID Numbers:	MSI-1256F-212
Study First Received:	June 1, 2006
Last Updated:	November 27, 2007
ClinicalTrials.gov Identifier:	NCT00333476 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Squalamine
Anticarcinogenic Agents
Uveal Diseases
Eye Diseases
Choroid Diseases
Macular Degeneration
Retinal Degeneration

Angiogenesis Inhibitors
Choroidal Neovascularization
Anti-Bacterial Agents
Metaplasia
Neovascularization, Pathologic
Retinal Diseases

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 July 02, 2009