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

Primary Purpose

Macular Degeneration

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MSI-1256F (Squalamine Lactate)
Sponsored by
Genaera Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Subfoveal Choroidal Neovascularization, Squalamine Lactate

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with a diagnosis of "wet" age-related macular degeneration Exclusion Criteria: Prior treatment of "wet" age-related macular degeneration in the affected eye in the past 3 months

Sites / Locations

  • Genaera Corporation

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 16, 2004
Last Updated
November 27, 2007
Sponsor
Genaera Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00089830
Brief Title
A Safety and Efficacy Study of MSI-1256F (Squalamine Lactate) To Treat "Wet" Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Terminated
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genaera Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Subfoveal Choroidal Neovascularization, Squalamine Lactate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MSI-1256F (Squalamine Lactate)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis of "wet" age-related macular degeneration Exclusion Criteria: Prior treatment of "wet" age-related macular degeneration in the affected eye in the past 3 months
Facility Information:
Facility Name
Genaera Corporation
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States

12. IPD Sharing Statement

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

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