Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD
NCT ID: NCT02727881
Last Updated: 2017-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
230 participants
INTERVENTIONAL
2016-04-12
2017-12-31
Brief Summary
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Detailed Description
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(Screening/Baseline to Week 36): Patients will be randomly assigned to one of 2 treatment groups in a 1:1 ratio:
* Squalamine lactate ophthalmic solution, 0.2% BID + ranibizumab every 4 weeks
* Placebo ophthalmic solution BID + monthly ranibizumab every 4 weeks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Squalamine solution, 0.2% BID
Squalamine lactate ophthalmic solution, 0.2% bis in die (BID) + ranibizumab every 4 weeks
Squalamine lactate ophthalmic solution, 0.2%
Squalamine lactate ophthalmic solution, 0.2%
ranibizumab
ranibizumab
Placebo solution BID
Placebo ophthalmic solution BID + ranibizumab every 4 weeks
Placebo Ophthalmic solution
Placebo Ophthalmic solution
ranibizumab
ranibizumab
Interventions
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Squalamine lactate ophthalmic solution, 0.2%
Squalamine lactate ophthalmic solution, 0.2%
Placebo Ophthalmic solution
Placebo Ophthalmic solution
ranibizumab
ranibizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising at least 50% of the total lesion area on fluorescein angiography (FA)
* Central subfield thickness (spectral domain (SD)-OCT central 1 mm) of ≥ 300 μm
* Best-corrected visual acuity (BCVA) 20/40 to 20/320 (73- to 24-letter score on the Early Treatment of Diabetic Retinopathy Study \[ETDRS\] chart)
Exclusion Criteria
* Pigment epithelial detachment (PED) without associated subretinal fluid and/or cystic retinal changes
* Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye
* Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease)
* Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement
* Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye
50 Years
110 Years
ALL
No
Sponsors
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Ohr Pharmaceutical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Avner Ingerman, MD
Role: STUDY_DIRECTOR
Ohr Pharmaceutical
Locations
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Investigational Site
Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Arcadia, California, United States
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Beverly Hills, California, United States
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Campbell, California, United States
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Fullerton, California, United States
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Glendale, California, United States
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Glendora, California, United States
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La Jolla, California, United States
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Laguna Hills, California, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Palm Desert, California, United States
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Palo Alto, California, United States
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Pasadena, California, United States
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Poway, California, United States
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Redlands, California, United States
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Sacramento, California, United States
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Bridgeport, Connecticut, United States
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Hamden, Connecticut, United States
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New London, Connecticut, United States
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Altamonte Springs, Florida, United States
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Boynton Beach, Florida, United States
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Fort Myers, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Sarasota, Florida, United States
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Stuart, Florida, United States
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Augusta, Georgia, United States
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‘Aiea, Hawaii, United States
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Berwyn, Illinois, United States
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Bloomington, Illinois, United States
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Chicago, Illinois, United States
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Sycamore, Illinois, United States
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New Albany, Indiana, United States
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Leawood, Kansas, United States
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Louisville, Kentucky, United States
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Paducah, Kentucky, United States
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Portland, Maine, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Glen Burnie, Maryland, United States
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Hagerstown, Maryland, United States
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Pikesville, Maryland, United States
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Rockville, Maryland, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Jackson, Michigan, United States
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Royal Oak, Michigan, United States
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Southfield, Michigan, United States
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Traverse City, Michigan, United States
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Biloxi, Mississippi, United States
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Chesterfield, Missouri, United States
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Florissant, Missouri, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Portsmouth, New Hampshire, United States
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Bloomfield, New Jersey, United States
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Lawrenceville, New Jersey, United States
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New Brunswick, New Jersey, United States
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Northfield, New Jersey, United States
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Ramsey, New Jersey, United States
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Teaneck, New Jersey, United States
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Toms River, New Jersey, United States
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Brooklyn, New York, United States
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Great Neck, New York, United States
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Hauppauge, New York, United States
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Lynbrook, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Rockville Centre, New York, United States
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Syracuse, New York, United States
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Charlotte, North Carolina, United States
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Concord, North Carolina, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Toledo, Ohio, United States
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Youngstown, Ohio, United States
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Ashland, Oregon, United States
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Camp Hill, Pennsylvania, United States
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Kingston, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Rapid City, South Dakota, United States
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Kingsport, Tennessee, United States
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Nashville, Tennessee, United States
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Fort Worth, Texas, United States
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Grapevine, Texas, United States
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Harlingen, Texas, United States
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Houston, Texas, United States
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Katy, Texas, United States
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Kingwood, Texas, United States
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McAllen, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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The Woodlands, Texas, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Fairfax, Virginia, United States
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Warrenton, Virginia, United States
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Bellevue, Washington, United States
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Spokane, Washington, United States
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Morgantown, West Virginia, United States
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Madison, Wisconsin, United States
Countries
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Other Identifiers
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OHR-1601
Identifier Type: -
Identifier Source: org_study_id
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