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

Primary Purpose

"Wet" Age-Related Macular Degeneration

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Squalamine Lactate
Sponsored by
Genaera Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for "Wet" Age-Related Macular Degeneration focused on measuring wet AMD, macular degeneration

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

Sites / Locations

  • Retina-Vitreous Associates Medical Group
  • Eldorado Retina Associates
  • Florida Eye Microsurgical Institute
  • National Ophthalmic Research Institute
  • University of Florida
  • Magruder Eye Institute
  • East Florida Eye Institute
  • Retina Associates of Florida
  • Center for Retina and Macular Disease
  • Midwest Eye Institute
  • Retina Associates, PA
  • Cumberland Valley Retina Consultants, PC
  • Delaware Valley Retina Associates
  • Retina Associates of New Jersey
  • MaculaCare
  • Charlotte Eye, Ear, Nose & Throat Associates
  • Horizon Eye Care
  • The Ohio State University, Havener Eye Institute
  • Penn State Ophthalmology
  • Retina Vitreous Consultants
  • University of Pittsburgh Medical Center
  • Genaera Corporation
  • Carolina Retina Center
  • Black Hills Regional Eye Institute
  • Southeastern Retina Associates
  • Retina Research Center
  • Garcia & Associates, MD, PA
  • John Moran Eye Center
  • Virginia Retina Center

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
August 29, 2005
Last Updated
November 27, 2007
Sponsor
Genaera Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00139282
Brief Title
A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Terminated
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
"Wet" Age-Related Macular Degeneration
Keywords
wet AMD, macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Squalamine Lactate
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Change in area of CNV in the study eye at 52 and 104 weeks compared to baseline, as measured by fluorescein angiography
Title
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
Title
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.

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 in the affected eye in the past 3 months
Facility Information:
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Eldorado Retina Associates
City
Louisville
State/Province
Colorado
ZIP/Postal Code
80027
Country
United States
Facility Name
Florida Eye Microsurgical Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Magruder Eye Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
East Florida Eye Institute
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
Retina Associates of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
Retina Associates, PA
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Cumberland Valley Retina Consultants, PC
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Delaware Valley Retina Associates
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Retina Associates of New Jersey
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
MaculaCare
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Charlotte Eye, Ear, Nose & Throat Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Horizon Eye Care
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
The Ohio State University, Havener Eye Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Penn State Ophthalmology
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Retina Vitreous Consultants
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Genaera Corporation
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Carolina Retina Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29223
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Southeastern Retina Associates
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Garcia & Associates, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
John Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Retina Center
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States

12. IPD Sharing Statement

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

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