A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration

November 27, 2007 updated by: Genaera Corporation

A Phase 3, Multicenter, Randomized, Double-Masked, Controlled Study of Squalamine Lactate (MSI-1256F) for Injection for the Treatment of Subfoveal 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 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 evaluate the safety and efficacy of Squalamine lactate in the treatment of AMD in patients, the exact number of which will be determined based on data from the sponsor's ongoing Phase 2 trials.

The trial objective is to evaluate the safety and efficacy of two doses of Squalamine lactate for Injection administered as intravenous infusions weekly for 4 weeks followed by maintenance doses every 4 weeks through week 104 compared with the safety and efficacy in the control group.

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

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

    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
    • Colorado
      • Louisville, Colorado, United States, 80027
        • Eldorado Retina Associates
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Florida Eye Microsurgical Institute
      • Fort Myers, Florida, United States, 33912
        • National Ophthalmic Research Institute
      • Jacksonville, Florida, United States, 32256
        • University of Florida
      • Orlando, Florida, United States, 32803
        • Magruder Eye Institute
      • Stuart, Florida, United States, 34994
        • East Florida Eye Institute
      • Tampa, Florida, United States, 33609
        • Retina Associates of Florida
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macular Disease
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • Midwest Eye Institute
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Retina Associates, PA
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants, PC
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Delaware Valley Retina Associates
      • Teaneck, New Jersey, United States, 07666
        • Retina Associates of New Jersey
    • New York
      • New York, New York, United States, 10021
        • MaculaCare
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Charlotte Eye, Ear, Nose & Throat Associates
      • Charlotte, North Carolina, United States, 28211
        • Horizon Eye Care
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University, Havener Eye Institute
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Ophthalmology
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • Retina Vitreous Consultants
      • Plymouth Meeting, Pennsylvania, United States, 19462
        • Genaera Corporation
    • South Carolina
      • Columbia, South Carolina, United States, 29223
        • Carolina Retina Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Southeastern Retina Associates
    • Texas
      • Austin, Texas, United States, 78705
        • Retina Research Center
      • Houston, Texas, United States, 77002
        • Garcia & Associates, MD, PA
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • John Moran Eye Center
    • Virginia
      • Leesburg, Virginia, United States, 20176
        • Virginia Retina Center

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:

  • Patients with a diagnosis of "wet" age-related macular degeneration

Exclusion Criteria:

  • Prior treatment for "wet" age-related macular degeneration in the affected eye in the past 3 months

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Loss in best corrected visual acuity (BCVA) of greater than or equal to 15 letters (ETDRS) at 52 weeks in the study eye compared to baseline.

Secondary Outcome Measures

Outcome Measure
Change in retinal thickness in the study eye at 52 and 104 weeks compared to baseline, as measured by OCT, in a subset of subjects
Change in area of CNV in the study eye at 52 and 104 weeks compared to baseline, as measured by fluorescein angiography
Gain or loss in BCVA of greater than or equal to 15 letters (ETDRS) at 52 and 104 weeks in the fellow eye compared to baseline in the subgroup of subjects whose fellow eye is affected with wet AMD
Loss in binocular visual acuity of greater than or equal to 15 letters at 52 and 104 weeks compared to baseline, using a modified ETDRS protocol.

Collaborators and Investigators

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

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

June 1, 2005

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 31, 2005

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

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.

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