- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00139282
A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration
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
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Beverly Hills, California, United States, 90211
- Retina-Vitreous Associates Medical Group
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Colorado
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Louisville, Colorado, United States, 80027
- Eldorado Retina Associates
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Florida
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Boynton Beach, Florida, United States, 33426
- Florida Eye Microsurgical Institute
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Fort Myers, Florida, United States, 33912
- National Ophthalmic Research Institute
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Jacksonville, Florida, United States, 32256
- University of Florida
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Orlando, Florida, United States, 32803
- Magruder Eye Institute
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Stuart, Florida, United States, 34994
- East Florida Eye Institute
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Tampa, Florida, United States, 33609
- Retina Associates of Florida
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Winter Haven, Florida, United States, 33880
- Center for Retina and Macular Disease
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Indiana
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Indianapolis, Indiana, United States, 46280
- Midwest Eye Institute
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Kansas
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Shawnee Mission, Kansas, United States, 66204
- Retina Associates, PA
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Maryland
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Hagerstown, Maryland, United States, 21740
- Cumberland Valley Retina Consultants, PC
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New Jersey
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Lawrenceville, New Jersey, United States, 08648
- Delaware Valley Retina Associates
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Teaneck, New Jersey, United States, 07666
- Retina Associates of New Jersey
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New York
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New York, New York, United States, 10021
- MaculaCare
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North Carolina
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Charlotte, North Carolina, United States, 28210
- Charlotte Eye, Ear, Nose & Throat Associates
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Charlotte, North Carolina, United States, 28211
- Horizon Eye Care
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University, Havener Eye Institute
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Ophthalmology
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States, 15213
- Retina Vitreous Consultants
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Plymouth Meeting, Pennsylvania, United States, 19462
- Genaera Corporation
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South Carolina
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Columbia, South Carolina, United States, 29223
- Carolina Retina Center
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Black Hills Regional Eye Institute
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Tennessee
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Kingsport, Tennessee, United States, 37660
- Southeastern Retina Associates
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Texas
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Austin, Texas, United States, 78705
- Retina Research Center
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Houston, Texas, United States, 77002
- Garcia & Associates, MD, PA
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Utah
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Salt Lake City, Utah, United States, 84132
- John Moran Eye Center
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Virginia
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Leesburg, Virginia, United States, 20176
- Virginia Retina Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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
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Change in area of CNV in the study eye at 52 and 104 weeks compared to baseline, as measured by fluorescein angiography
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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
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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.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Protective Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Anticarcinogenic Agents
- Squalamine
Other Study ID Numbers
- MSI-1256F-301
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 "Wet" Age-Related Macular Degeneration
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Sam Chun Dang Pharm. Co. Ltd.CompletedNeovascular Age-related Macular Degeneration | Wet Age-related Macular DegenerationUnited States, Australia, Bulgaria, Czechia, Hungary, India, Israel, Japan, Korea, Republic of, Latvia, Poland, Russian Federation, Slovakia, Spain
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Novartis PharmaceuticalsWithdrawnWet Age-related Macular Degeneration (Wet AMD)
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Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationChina
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Hoffmann-La RocheWithdrawnNeovascular Age-Related Macular DegenerationDenmark, Argentina, Hong Kong, Thailand, Portugal, Greece, Spain
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Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationSpain, Italy, Germany, Canada, Ireland
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Novartis PharmaceuticalsTerminatedNeovascular Age-Related Macular Degeneration
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Regeneron PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States
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Caregen Co. Ltd.CBCC Global ResearchNot yet recruitingAge-related Wet Macular DegenerationUnited States
-
AbbVieAbbVieEnrolling by invitationGene Therapy | AMD | nAMD | Wet AMD | Neovascular Age-Related Macular Degeneration (nAMD) | wAMDUnited States
Clinical Trials on Squalamine Lactate
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Starr MuscleOhr Pharmaceutical Inc.WithdrawnDiabetic RetinopathyUnited States
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Genaera CorporationTerminatedMacular DegenerationUnited States
-
Genaera CorporationTerminatedMacular DegenerationUnited States
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Unknown
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Ohr Pharmaceutical Inc.CompletedNeovascular Age Related Macular DegenerationUnited States
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Genaera CorporationTerminatedMacular DegenerationUnited States
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Elman Retina GroupCompletedRetinal NeovascularizationUnited States
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Ohr Pharmaceutical Inc.Cumberland Valley Retina Consultants, PCCompletedMacular Edema | Retinal Vein Occlusion
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Ohr Pharmaceutical Inc.WithdrawnAge-Related Macular DegenerationUnited States
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Nantes University HospitalCompleted