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

November 27, 2007 updated by: Genaera Corporation

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Registration Dates

First Submitted

June 1, 2006

First Submitted That Met QC Criteria

June 1, 2006

First Posted (Estimate)

June 5, 2006

Study Record Updates

Last Update Posted (Estimate)

November 28, 2007

Last Update Submitted That Met QC Criteria

November 27, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSI-1256F-212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Macular Degeneration

Clinical Trials on MSI-1256F (Squalamine Lactate)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe