Clincosm LogoSign in Get a demo

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

Sponsor
Ohr Pharmaceutical Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02727881
Collaborator
(none)
230
Enrollment
118
Locations
2
Arms
19.6
Anticipated Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: Squalamine lactate ophthalmic solution, 0.2%
  • Drug: Placebo Ophthalmic solution
  • Drug: ranibizumab
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
230 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date :
Apr 12, 2016
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

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: Placebo Ophthalmic solution
    Placebo Ophthalmic solution
    Other Names:
  • placebo

    • Drug: ranibizumab
    ranibizumab
    Other Names:
  • Lucentis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Functional change in visual acuity [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

    Secondary Outcome Measures

    1. Functional changes in visual acuity [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

    Other Outcome Measures

    1. Treatment emergent Adverse Event (AE) monitoring [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 110 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Mobile Alabama United States 36608
    2 Investigational Site Phoenix Arizona United States 85014
    3 Investigational Site Phoenix Arizona United States 85020
    4 Investigational Site Phoenix Arizona United States 85021
    5 Investigational Site Tucson Arizona United States 85704
    6 Investigational Site Arcadia California United States 91007
    7 Investigational Site Beverly Hills California United States 90211
    8 Investigational Site Campbell California United States 95008
    9 Investigational Site Fullerton California United States 92835
    10 Investigational Site Glendale California United States 91203
    11 Investigational Site Glendora California United States 91741
    12 Investigational Site La Jolla California United States 92093
    13 Investigational Site Laguna Hills California United States 92653
    14 Investigational Site Loma Linda California United States 92354
    15 Investigational Site Los Angeles California United States 90017
    16 Investigational Site Oceanside California United States 92056
    17 Investigational Site Orange California United States 92868
    18 Investigational Site Palm Desert California United States 92260
    19 Investigational Site Palo Alto California United States 94303
    20 Investigational Site Pasadena California United States 91107
    21 Investigational Site Poway California United States 92064
    22 Investigational Site Redlands California United States 92374
    23 Investigational Site Sacramento California United States 91007
    24 Investigational Site Bridgeport Connecticut United States 06606
    25 Investigational Site Hamden Connecticut United States 06518
    26 Investigational Site New London Connecticut United States 06320
    27 Investigational Site Altamonte Springs Florida United States 32701
    28 Investigational Site Boynton Beach Florida United States 33426
    29 Investigational Site Fort Myers Florida United States 33901
    30 Investigational Site Miami Florida United States 33136
    31 Investigational Site Miami Florida United States 33143
    32 Investigational Site Naples Florida United States 34103
    33 Investigational Site Sarasota Florida United States 34233
    34 Investigational Site Stuart Florida United States 34994
    35 Investigational Site Augusta Georgia United States 30909
    36 Investigational Site 'Aiea Hawaii United States 96701
    37 Investigational Site Berwyn Illinois United States 60402
    38 Investigational Site Bloomington Illinois United States 61704
    39 Investigational Site Chicago Illinois United States 60612
    40 Investigational Site Sycamore Illinois United States 60178
    41 Investigational Site New Albany Indiana United States 47150
    42 Investigational Site Leawood Kansas United States 66211
    43 Investigational Site Louisville Kentucky United States 40202
    44 Investigational Site Paducah Kentucky United States 42001
    45 Investigational Site Portland Maine United States 04102
    46 Investigational Site Baltimore Maryland United States 21209
    47 Investigational Site Baltimore Maryland United States 21237
    48 Investigational Site Glen Burnie Maryland United States 21061
    49 Investigational Site Hagerstown Maryland United States 21740
    50 Investigational Site Pikesville Maryland United States 21208
    51 Investigational Site Rockville Maryland United States 20877
    52 Investigational Site Detroit Michigan United States 48201
    53 Investigational Site Grand Rapids Michigan United States 49546
    54 Investigational Site Jackson Michigan United States 49202
    55 Investigational Site Royal Oak Michigan United States 48073
    56 Investigational Site Southfield Michigan United States 48304
    57 Investigational Site Traverse City Michigan United States 49686
    58 Investigational Site Biloxi Mississippi United States 39532
    59 Investigational Site Chesterfield Missouri United States 63017
    60 Investigational Site Florissant Missouri United States 63031
    61 Investigational Site Henderson Nevada United States 89052
    62 Investigational Site Las Vegas Nevada United States 89144
    63 Investigational Site Portsmouth New Hampshire United States 03801
    64 Investigational Site Bloomfield New Jersey United States 07003
    65 Investigational Site Lawrenceville New Jersey United States 08648
    66 Investigational Site New Brunswick New Jersey United States 08901
    67 Investigational Site Northfield New Jersey United States 08225
    68 Investigational Site Ramsey New Jersey United States 07446
    69 Investigational Site Teaneck New Jersey United States 07666
    70 Investigational Site Toms River New Jersey United States 07083
    71 Investigational Site Brooklyn New York United States 11223
    72 Investigational Site Great Neck New York United States 11021
    73 Investigational Site Hauppauge New York United States 11788
    74 Investigational Site Lynbrook New York United States 11563
    75 Investigational Site New York New York United States 10003
    76 Investigational Site New York New York United States 10032
    77 Investigational Site Rochester New York United States 14620
    78 Investigational Site Rockville Centre New York United States 11570
    79 Investigational Site Syracuse New York United States 13224
    80 Investigational Site Charlotte North Carolina United States 28210
    81 Investigational Site Concord North Carolina United States 28025
    82 Investigational Site Cleveland Ohio United States 44122
    83 Investigational Site Cleveland Ohio United States 44130
    84 Investigational Site Cleveland Ohio United States 44195
    85 Investigational Site Toledo Ohio United States 43615
    86 Investigational Site Youngstown Ohio United States 44505
    87 Investigational Site Ashland Oregon United States 97520
    88 Investigational Site Camp Hill Pennsylvania United States 17011
    89 Investigational Site Kingston Pennsylvania United States 18704
    90 Investigational Site Lancaster Pennsylvania United States 17601
    91 Investigational Site Philadelphia Pennsylvania United States 19104
    92 Investigational Site Philadelphia Pennsylvania United States 19107
    93 Investigational Site Philadelphia Pennsylvania United States 19116
    94 Investigational Site Pittsburgh Pennsylvania United States 15213
    95 Investigational Site Columbia South Carolina United States 29223
    96 Investigational Site Greenville South Carolina United States 29605
    97 Investigational Site Mount Pleasant South Carolina United States 29464
    98 Investigational Site Rapid City South Dakota United States 57701
    99 Investigational Site Kingsport Tennessee United States 37660
    100 Investigational Site Nashville Tennessee United States 37203
    101 Investigational Site Fort Worth Texas United States 76107
    102 Investigational Site Grapevine Texas United States 76051
    103 Investigational Site Harlingen Texas United States 78550
    104 Investigational Site Houston Texas United States 77030
    105 Investigational Site Katy Texas United States 77494
    106 Investigational Site Kingwood Texas United States 77339
    107 Investigational Site McAllen Texas United States 78503
    108 Investigational Site Plano Texas United States 75075
    109 Investigational Site San Antonio Texas United States 78240
    110 Investigational Site The Woodlands Texas United States 77384
    111 Investigational Site Salt Lake City Utah United States 84107
    112 Investigational Site Burlington Vermont United States 05401
    113 Investigational Site Fairfax Virginia United States 22031
    114 Investigational Site Warrenton Virginia United States 20186
    115 Investigational Site Bellevue Washington United States 98004
    116 Investigational Site Spokane Washington United States 99204
    117 Investigational Site Morgantown West Virginia United States 26501
    118 Investigational Site Madison Wisconsin United States 53705

    Sponsors and Collaborators

    • Ohr Pharmaceutical Inc.

    Investigators

    • Study Director: Avner Ingerman, MD, Ohr Pharmaceutical

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ohr Pharmaceutical Inc.
    ClinicalTrials.gov Identifier:
    NCT02727881
    Other Study ID Numbers:
    • OHR-1601
    First Posted:
    Apr 5, 2016
    Last Update Posted:
    Apr 27, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Ohr Pharmaceutical Inc.
    AMD, CNV, choroidal neovascularization, retinal eye disease
    Additional relevant MeSH terms:
    Macular Degeneration
    Squalamine
    Ranibizumab
    Pharmaceutical Solutions
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Apr 27, 2017