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

April 25, 2017 updated by: Ohr Pharmaceutical Inc.

OHR-1601: A Phase III Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects With Neovascular Age-Related Macular Degeneration (AMD)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Investigational Site
      • Phoenix, Arizona, United States, 85021
        • Investigational Site
      • Phoenix, Arizona, United States, 85014
        • Investigational Site
      • Tucson, Arizona, United States, 85704
        • Investigational Site
    • California
      • Arcadia, California, United States, 91007
        • Investigational Site
      • Beverly Hills, California, United States, 90211
        • Investigational Site
      • Campbell, California, United States, 95008
        • Investigational Site
      • Fullerton, California, United States, 92835
        • Investigational Site
      • Glendale, California, United States, 91203
        • Investigational Site
      • Glendora, California, United States, 91741
        • Investigational Site
      • La Jolla, California, United States, 92093
        • Investigational Site
      • Laguna Hills, California, United States, 92653
        • Investigational Site
      • Loma Linda, California, United States, 92354
        • Investigational Site
      • Los Angeles, California, United States, 90017
        • Investigational Site
      • Oceanside, California, United States, 92056
        • Investigational Site
      • Orange, California, United States, 92868
        • Investigational Site
      • Palm Desert, California, United States, 92260
        • Investigational Site
      • Palo Alto, California, United States, 94303
        • Investigational Site
      • Pasadena, California, United States, 91107
        • Investigational Site
      • Poway, California, United States, 92064
        • Investigational Site
      • Redlands, California, United States, 92374
        • Investigational Site
      • Sacramento, California, United States, 91007
        • Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Investigational Site
      • Hamden, Connecticut, United States, 06518
        • Investigational Site
      • New London, Connecticut, United States, 06320
        • Investigational Site
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Investigational Site
      • Boynton Beach, Florida, United States, 33426
        • Investigational Site
      • Fort Myers, Florida, United States, 33901
        • Investigational Site
      • Miami, Florida, United States, 33143
        • Investigational Site
      • Miami, Florida, United States, 33136
        • Investigational Site
      • Naples, Florida, United States, 34103
        • Investigational Site
      • Sarasota, Florida, United States, 34233
        • Investigational Site
      • Stuart, Florida, United States, 34994
        • Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Investigational Site
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Investigational Site
    • Illinois
      • Berwyn, Illinois, United States, 60402
        • Investigational Site
      • Bloomington, Illinois, United States, 61704
        • Investigational Site
      • Chicago, Illinois, United States, 60612
        • Investigational Site
      • Sycamore, Illinois, United States, 60178
        • Investigational Site
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Investigational Site
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Investigational Site
      • Paducah, Kentucky, United States, 42001
        • Investigational Site
    • Maine
      • Portland, Maine, United States, 04102
        • Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Investigational Site
      • Baltimore, Maryland, United States, 21209
        • Investigational Site
      • Glen Burnie, Maryland, United States, 21061
        • Investigational Site
      • Hagerstown, Maryland, United States, 21740
        • Investigational Site
      • Pikesville, Maryland, United States, 21208
        • Investigational Site
      • Rockville, Maryland, United States, 20877
        • Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Investigational Site
      • Grand Rapids, Michigan, United States, 49546
        • Investigational Site
      • Jackson, Michigan, United States, 49202
        • Investigational Site
      • Royal Oak, Michigan, United States, 48073
        • Investigational Site
      • Southfield, Michigan, United States, 48304
        • Investigational Site
      • Traverse City, Michigan, United States, 49686
        • Investigational Site
    • Mississippi
      • Biloxi, Mississippi, United States, 39532
        • Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Investigational Site
      • Florissant, Missouri, United States, 63031
        • Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Investigational Site
      • Las Vegas, Nevada, United States, 89144
        • Investigational Site
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Investigational Site
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Investigational Site
      • Lawrenceville, New Jersey, United States, 08648
        • Investigational Site
      • New Brunswick, New Jersey, United States, 08901
        • Investigational Site
      • Northfield, New Jersey, United States, 08225
        • Investigational Site
      • Ramsey, New Jersey, United States, 07446
        • Investigational Site
      • Teaneck, New Jersey, United States, 07666
        • Investigational Site
      • Toms River, New Jersey, United States, 07083
        • Investigational Site
    • New York
      • Brooklyn, New York, United States, 11223
        • Investigational Site
      • Great Neck, New York, United States, 11021
        • Investigational Site
      • Hauppauge, New York, United States, 11788
        • Investigational Site
      • Lynbrook, New York, United States, 11563
        • Investigational Site
      • New York, New York, United States, 10003
        • Investigational Site
      • New York, New York, United States, 10032
        • Investigational Site
      • Rochester, New York, United States, 14620
        • Investigational Site
      • Rockville Centre, New York, United States, 11570
        • Investigational Site
      • Syracuse, New York, United States, 13224
        • Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Investigational Site
      • Concord, North Carolina, United States, 28025
        • Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Investigational Site
      • Cleveland, Ohio, United States, 44130
        • Investigational Site
      • Toledo, Ohio, United States, 43615
        • Investigational Site
      • Youngstown, Ohio, United States, 44505
        • Investigational Site
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Investigational Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Investigational Site
      • Kingston, Pennsylvania, United States, 18704
        • Investigational Site
      • Lancaster, Pennsylvania, United States, 17601
        • Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Investigational Site
      • Philadelphia, Pennsylvania, United States, 19116
        • Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29223
        • Investigational Site
      • Greenville, South Carolina, United States, 29605
        • Investigational Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Investigational Site
    • Texas
      • Fort Worth, Texas, United States, 76107
        • Investigational Site
      • Grapevine, Texas, United States, 76051
        • Investigational Site
      • Harlingen, Texas, United States, 78550
        • Investigational Site
      • Houston, Texas, United States, 77030
        • Investigational Site
      • Katy, Texas, United States, 77494
        • Investigational Site
      • Kingwood, Texas, United States, 77339
        • Investigational Site
      • McAllen, Texas, United States, 78503
        • Investigational Site
      • Plano, Texas, United States, 75075
        • Investigational Site
      • San Antonio, Texas, United States, 78240
        • Investigational Site
      • The Woodlands, Texas, United States, 77384
        • Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Investigational Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Investigational Site
      • Warrenton, Virginia, United States, 20186
        • Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Investigational Site
      • Spokane, Washington, United States, 99204
        • Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26501
        • Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 110 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 50 years
  • 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Squalamine solution, 0.2% BID
Squalamine lactate ophthalmic solution, 0.2% bis in die (BID) + ranibizumab every 4 weeks
Drug: Squalamine lactate ophthalmic solution, 0.2%
Squalamine lactate ophthalmic solution, 0.2%
Other Names:
  • active
Drug: ranibizumab
ranibizumab
Other Names:
  • Lucentis
PLACEBO_COMPARATOR: Placebo solution BID
Placebo ophthalmic solution BID + ranibizumab every 4 weeks
Drug: ranibizumab
ranibizumab
Other Names:
  • Lucentis
Drug: Placebo Ophthalmic solution
Placebo Ophthalmic solution
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional change in visual acuity
Time Frame: 9 months
Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional changes in visual acuity
Time Frame: 9 months
Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration
9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment emergent Adverse Event (AE) monitoring
Time Frame: 9 months
Adverse and Serious Adverse Events in subjects receiving combination therapy of ranibizumab intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% assessed by adverse event reporting and Ophthalmic examinations
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohr Pharmaceutical Inc.

Investigators

  • Study Director: Avner Ingerman, MD, Ohr Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 12, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (ESTIMATE)

April 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHR-1601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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