Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD

Last updated: April 25, 2017
Sponsor: Ohr Pharmaceutical Inc.
Overall Status: Trial Status Unknown

Phase

3

Condition

Myopic Macular Degeneration

Aging

Macular Degeneration

Treatment

N/A

Clinical Study ID

NCT02727881
OHR-1601
  • Ages 50-110
  • All Genders

Study Summary

A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will receive injections of ranibizumab. In addition, patients will receive either Squalamine lactate 0.2% eye drops or Placebo eye drops. The study duration is approximately 9 months to primary endpoint

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 50 years

  • A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprisingat 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 theEarly Treatment of Diabetic Retinopathy Study [ETDRS] chart)

Exclusion

Exclusion Criteria:

  • Neovascularization secondary to any other condition than AMD in the study eye; Bloodoccupying greater than 50% of the AMD lesion, or blood > 1.0 sq. mm underlying thefovea

  • Pigment epithelial detachment (PED) without associated subretinal fluid and/or cysticretinal 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 ofOCT, 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 studyeye or any condition preventing VA improvement

  • Uncontrolled glaucoma in the study eye, or currently receiving topical glaucomamedication in the study eye

Study Design

Total Participants: 230
Study Start date:
April 12, 2016
Estimated Completion Date:
December 31, 2017

Study Description

Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration Methodology: Phase III, multicenter, randomized, double-masked, placebo-controlled study conducted over 9 months

(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

Connect with a study center

  • Investigational Site

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Investigational Site

    Phoenix, Arizona 85014
    United States

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  • Investigational Site

    Tucson, Arizona 85704
    United States

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  • Investigational Site

    Arcadia, California 91007
    United States

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  • Investigational Site

    Beverly Hills, California 90211
    United States

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  • Investigational Site

    Campbell, California 95008
    United States

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  • Investigational Site

    Fullerton, California 92835
    United States

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  • Investigational Site

    Glendale, California 91203
    United States

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  • Investigational Site

    Glendora, California 91741
    United States

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  • Investigational Site

    La Jolla, California 92093
    United States

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  • Investigational Site

    Laguna Hills, California 92653
    United States

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  • Investigational Site

    Loma Linda, California 92354
    United States

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  • Investigational Site

    Los Angeles, California 90017
    United States

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  • Investigational Site

    Oceanside, California 92056
    United States

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  • Investigational Site

    Orange, California 92868
    United States

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  • Investigational Site

    Palm Desert, California 92260
    United States

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    Palo Alto, California 94303
    United States

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  • Investigational Site

    Pasadena, California 91107
    United States

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  • Investigational Site

    Poway, California 92064
    United States

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  • Investigational Site

    Redlands, California 92374
    United States

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  • Investigational Site

    Sacramento, California 91007
    United States

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  • Investigational Site

    Bridgeport, Connecticut 06606
    United States

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  • Investigational Site

    Hamden, Connecticut 06518
    United States

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  • Investigational Site

    New London, Connecticut 06320
    United States

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  • Investigational Site

    Altamonte Springs, Florida 32701
    United States

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  • Investigational Site

    Boynton Beach, Florida 33426
    United States

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    Fort Myers, Florida 33901
    United States

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  • Investigational Site

    Ft. Myers, Florida 33901
    United States

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    Miami, Florida 33143
    United States

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    Naples, Florida 34103
    United States

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    Sarasota, Florida 34233
    United States

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    Stuart, Florida 34994
    United States

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  • Investigational Site

    Augusta, Georgia 30909
    United States

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  • Investigational Site

    'Aiea, Hawaii 96701
    United States

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  • Investigational Site

    Aiea, Hawaii 96701
    United States

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    Berwyn, Illinois 60402
    United States

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    Bloomington, Illinois 61704
    United States

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    Chicago, Illinois 60612
    United States

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    Sycamore, Illinois 60178
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    New Albany, Indiana 47150
    United States

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    Leawood, Kansas 66211
    United States

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    Louisville, Kentucky 40202
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    Paducah, Kentucky 42001
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    Portland, Maine 04102
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    Baltimore, Maryland 21209
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    Glen Burnie, Maryland 21061
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    Hagerstown, Maryland 21740
    United States

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    Pikesville, Maryland 21208
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    Rockville, Maryland 20877
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  • Investigational Site

    Detroit, Michigan 48201
    United States

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    Grand Rapids, Michigan 49546
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    Jackson, Michigan 49202
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    Royal Oak, Michigan 48073
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    Southfield, Michigan 48304
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    Traverse City, Michigan 49686
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    Biloxi, Mississippi 39532
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    Chesterfield, Missouri 63017
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    Florissant, Missouri 63031
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    Henderson, Nevada 89052
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  • Investigational Site

    Las Vegas, Nevada 89144
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    Portsmouth, New Hampshire 03801
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    Bloomfield, New Jersey 07003
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    Lawrenceville, New Jersey 08648
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  • Investigational Site

    New Brunswick, New Jersey 08901
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    Northfield, New Jersey 08225
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  • Investigational Site

    Ramsey, New Jersey 07446
    United States

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  • Investigational Site

    Teaneck, New Jersey 07666
    United States

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  • Investigational Site

    Toms River, New Jersey 07083
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  • Investigational Site

    Brooklyn, New York 11223
    United States

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  • Investigational Site

    Great Neck, New York 11021
    United States

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    Hauppauge, New York 11788
    United States

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  • Investigational Site

    Lynbrook, New York 11563
    United States

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  • Investigational Site

    New York, New York 10032
    United States

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    Rochester, New York 14620
    United States

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    Rockville Centre, New York 11570
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    Syracuse, New York 13224
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    Charlotte, North Carolina 28210
    United States

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    Concord, North Carolina 28025
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    Cleveland, Ohio 44130
    United States

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    Toledo, Ohio 43615
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    Youngstown, Ohio 44505
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    Ashland, Oregon 97520
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    Camp Hill, Pennsylvania 17011
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    Kingston, Pennsylvania 18704
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    Lancaster, Pennsylvania 17601
    United States

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    Philadelphia, Pennsylvania 19116
    United States

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    Pittsburgh, Pennsylvania 15213
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  • Investigational Site

    Columbia, South Carolina 29223
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  • Investigational Site

    Greenville, South Carolina 29605
    United States

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  • Investigational Site

    Mount Pleasant, South Carolina 29464
    United States

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  • Investigational Site

    Mt. Pleasant, South Carolina 29464
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  • Investigational Site

    Rapid City, South Dakota 57701
    United States

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  • Investigational Site

    Kingsport, Tennessee 37660
    United States

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  • Investigational Site

    Nashville, Tennessee 37203
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  • Investigational Site

    Fort Worth, Texas 76107
    United States

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  • Investigational Site

    Ft. Worth, Texas 76107
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    Grapevine, Texas 76051
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    Harlingen, Texas 78550
    United States

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    Houston, Texas 77030
    United States

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    Katy, Texas 77494
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    Kingwood, Texas 77339
    United States

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    McAllen, Texas 78503
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  • Investigational Site

    Plano, Texas 75075
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  • Investigational Site

    San Antonio, Texas 78240
    United States

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  • Investigational Site

    The Woodlands, Texas 77384
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  • Investigational Site

    Woodlands, Texas 77384
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  • Investigational Site

    Salt Lake City, Utah 84107
    United States

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  • Investigational Site

    Burlington, Vermont 05401
    United States

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  • Investigational Site

    Fairfax, Virginia 22031
    United States

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  • Investigational Site

    Warrenton, Virginia 20186
    United States

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  • Investigational Site

    Bellevue, Washington 98004
    United States

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  • Investigational Site

    Spokane, Washington 99204
    United States

    Site Not Available

  • Investigational Site

    Morgantown, West Virginia 26501
    United States

    Site Not Available

  • Investigational Site

    Madison, Wisconsin 53705
    United States

    Site Not Available

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