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

Condition(s) targeted: Macular Degeneration

Intervention: MSI-1256F (Squalamine Lactate) (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Genaera Corporation

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

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.

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

Study design: Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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.

Florida Eye Microsurgical Institute, Boynton Beach, Florida 33426, United States

Retina Health Center, Fort Meyers, Florida 33907, United States

Bascom Palmer Eye Institute, Miami, Florida 33136, United States

Midwest Eye Institute, Indianapolis, Indiana 46280, United States

Retina Specialists, Towson, Maryland 21204, United States

Eye Foundation of Kansas City, Kansas City, Missouri 64108, United States

Ophthalmic Consultants of Long Island, Long Island, New York 11563, United States

Retina Associates of Western New York, Rochester, New York 14618, United States

Charles Garcia, MD, P.A., Houston, Texas 77002, United States

Starting date: May 2006
Last updated: November 27, 2007