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

Tracking Information

First Received Date ^ICMJE

June 1, 2006

Last Updated Date

November 27, 2007

Start Date ^ICMJE

May 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00333476 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Macular Degeneration

Intervention ^ICMJE

Drug: MSI-1256F (Squalamine Lactate)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

140

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00333476

Responsible Party

Study ID Numbers ^ICMJE

MSI-1256F-212

Study Sponsor ^ICMJE

Genaera Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Genaera Corporation

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP