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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02727881
Recruitment Status : Unknown
Verified April 2017 by Ohr Pharmaceutical Inc..
Recruitment status was:  Active, not recruiting
First Posted : April 5, 2016
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ohr Pharmaceutical Inc.

Study Description
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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
Age-related Macular Degeneration 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
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Study Type : Interventional  (Clinical Trial)
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 : April 12, 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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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 Name: active

Drug: ranibizumab
ranibizumab
Other Name: Lucentis
Placebo Comparator: Placebo solution BID
Placebo ophthalmic solution BID + ranibizumab every 4 weeks
 Drug: Placebo Ophthalmic solution
Placebo Ophthalmic solution
Other Name: placebo

Drug: ranibizumab
ranibizumab
Other Name: Lucentis


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727881


Locations
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Sponsors and Collaborators
Ohr Pharmaceutical Inc.
Investigators
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Study Director: Avner Ingerman, MD Ohr Pharmaceutical
More Information
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Responsible Party: Ohr Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT02727881    
Other Study ID Numbers: OHR-1601
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ohr Pharmaceutical Inc.:
AMD, CNV, choroidal neovascularization, retinal eye disease
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Squalamine
Ranibizumab
Pharmaceutical Solutions
Ophthalmic Solutions
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anticarcinogenic Agents
Protective Agents