We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02727881
First Posted: April 5, 2016
Last Update Posted: April 27, 2017
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.
Information provided by (Responsible Party):
Ohr Pharmaceutical Inc.
  Purpose
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 Intervention Phase
Age-related Macular Degeneration Drug: Squalamine lactate ophthalmic solution, 0.2% Drug: Placebo Ophthalmic solution Drug: ranibizumab Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Ohr Pharmaceutical Inc.:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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


Enrollment: 230
Actual Study Start Date: April 12, 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 110 Years   (Adult, Senior)
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
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


  Show 118 Study Locations
Sponsors and Collaborators
Ohr Pharmaceutical Inc.
Investigators
Study Director: Avner Ingerman, MD Ohr Pharmaceutical
  More Information

Responsible Party: Ohr Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT02727881     History of Changes
Other Study ID Numbers: OHR-1601
First Submitted: March 28, 2016
First Posted: April 5, 2016
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:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pharmaceutical Solutions
Ranibizumab
Squalamine
Ophthalmic Solutions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anticarcinogenic Agents
Protective Agents