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

Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00333476
• Other study ID #: MSI-1256F-212
• Status: Terminated
• Phase: Phase 2
• First received: June 1, 2006
• Last updated: November 27, 2007
• Start date: May 2006

Study information

• Verified date: November 2007
• Source: Genaera Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration

Intervention

Drug:
• MSI-1256F (Squalamine Lactate)

Locations

Country	Name	City	State
United States	Florida Eye Microsurgical Institute	Boynton Beach	Florida
United States	Retina Health Center	Fort Meyers	Florida
United States	Charles Garcia, MD, P.A.	Houston	Texas
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	Eye Foundation of Kansas City	Kansas City	Missouri
United States	Ophthalmic Consultants of Long Island	Long Island	New York
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	Retina Associates of Western New York	Rochester	New York
United States	Retina Specialists	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Genaera Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate
Secondary	To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by optical coherence tomography
Secondary	To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by fluorescein angiography