Back to resultsMSI-1256F (Squalamine Lactate) in Combination With Verteporfin in Patients With "Wet" Age-Related Macular Degeneration (AMD)
Primary Purpose
Macular Degeneration
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MSI-1256F (Squalamine Lactate)
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring Age-Related Macular Degeneration - Wet Type
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis of "wet" age-related macular degeneration Exclusion Criteria: Prior treatment for "wet" age-related macular degeneration
Sites / Locations
- Genaera Corporation
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00094120
Brief Title
MSI-1256F (Squalamine Lactate) in Combination With Verteporfin in Patients With "Wet" Age-Related Macular Degeneration (AMD)
Official Title
Safety and Efficacy of MSI-1256F (Squalamine Lactate) in Combination With Verteporfin in Patients With "Wet" Age-Related Macular Degeneration (AMD)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Terminated
Study Start Date
October 2004 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 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 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 when administered with verteporfin therapy in patients with "wet" AMD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Age-Related Macular Degeneration - Wet Type
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (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 for "wet" age-related macular degeneration
Facility Information:
Facility Name
Genaera Corporation
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MSI-1256F (Squalamine Lactate) in Combination With Verteporfin in Patients With "Wet" Age-Related Macular Degeneration (AMD)
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