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

NCT02727881 | Unknown Phase 3 DMC

• 1 other identifier: OHR-1601
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 118

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

Conditions

Age-related Macular Degeneration

Keywords

AMD, CNV, choroidal neovascularization, retinal eye disease

Outcome Measures

Primary Outcomes (1)

• Functional change in visual acuity

  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 Outcomes (1)

• Functional changes in visual acuity

  9 months

Other Outcomes (1)

• Treatment emergent Adverse Event (AE) monitoring

  9 months

Study Arms (2)

Squalamine solution, 0.2% BID

EXPERIMENTAL

Squalamine lactate ophthalmic solution, 0.2% bis in die (BID) + ranibizumab every 4 weeks

Drug: Squalamine lactate ophthalmic solution, 0.2%; Drug: ranibizumab

Placebo solution BID

PLACEBO COMPARATOR

Placebo ophthalmic solution BID + ranibizumab every 4 weeks

Drug: Placebo Ophthalmic solution; Drug: ranibizumab

Interventions

Squalamine lactate ophthalmic solution, 0.2% DRUG

Squalamine lactate ophthalmic solution, 0.2%

Also known as: active

Squalamine solution, 0.2% BID

Placebo Ophthalmic solution DRUG

Placebo Ophthalmic solution

Also known as: placebo

Placebo solution BID

ranibizumab DRUG

ranibizumab

Also known as: Lucentis

Placebo solution BID; Squalamine solution, 0.2% BID

Eligibility Criteria

• Age: 50 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohr Pharmaceutical Inc.: lead

Study Sites (118)

Investigational Site

Mobile, Alabama, 36608, United States

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Investigational Site

Phoenix, Arizona, 85014, United States

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Phoenix, Arizona, 85020, United States

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Phoenix, Arizona, 85021, United States

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Tucson, Arizona, 85704, United States

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Arcadia, California, 91007, United States

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Beverly Hills, California, 90211, United States

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Campbell, California, 95008, United States

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Fullerton, California, 92835, United States

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Glendale, California, 91203, United States

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Glendora, California, 91741, United States

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La Jolla, California, 92093, United States

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Laguna Hills, California, 92653, United States

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Loma Linda, California, 92354, United States

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Los Angeles, California, 90017, United States

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Oceanside, California, 92056, United States

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Orange, California, 92868, United States

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Palm Desert, California, 92260, United States

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Palo Alto, California, 94303, United States

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Pasadena, California, 91107, United States

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Poway, California, 92064, United States

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Redlands, California, 92374, United States

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Sacramento, California, 91007, United States

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Bridgeport, Connecticut, 06606, United States

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Hamden, Connecticut, 06518, United States

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New London, Connecticut, 06320, United States

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Altamonte Springs, Florida, 32701, United States

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Boynton Beach, Florida, 33426, United States

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Fort Myers, Florida, 33901, United States

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Miami, Florida, 33136, 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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Augusta, Georgia, 30909, United States

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‘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, United States

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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, United States

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Paducah, Kentucky, 42001, United States

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Portland, Maine, 04102, United States

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Baltimore, Maryland, 21209, United States

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Baltimore, Maryland, 21237, United States

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Glen Burnie, Maryland, 21061, United States

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Hagerstown, Maryland, 21740, United States

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Pikesville, Maryland, 21208, United States

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Rockville, Maryland, 20877, United States

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Detroit, Michigan, 48201, United States

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Grand Rapids, Michigan, 49546, United States

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Jackson, Michigan, 49202, United States

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Royal Oak, Michigan, 48073, United States

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Southfield, Michigan, 48304, United States

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Traverse City, Michigan, 49686, United States

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Biloxi, Mississippi, 39532, United States

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Chesterfield, Missouri, 63017, United States

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Florissant, Missouri, 63031, United States

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Henderson, Nevada, 89052, United States

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Las Vegas, Nevada, 89144, United States

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Portsmouth, New Hampshire, 03801, United States

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Bloomfield, New Jersey, 07003, United States

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Lawrenceville, New Jersey, 08648, United States

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New Brunswick, New Jersey, 08901, United States

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Northfield, New Jersey, 08225, United States

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Ramsey, New Jersey, 07446, United States

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Teaneck, New Jersey, 07666, United States

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Toms River, New Jersey, 07083, United States

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Brooklyn, New York, 11223, United States

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Great Neck, New York, 11021, United States

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Hauppauge, New York, 11788, United States

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Lynbrook, New York, 11563, United States

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New York, New York, 10003, United States

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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, United States

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Syracuse, New York, 13224, United States

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Charlotte, North Carolina, 28210, United States

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Concord, North Carolina, 28025, United States

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Cleveland, Ohio, 44122, United States

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Cleveland, Ohio, 44130, United States

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Cleveland, Ohio, 44195, United States

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Toledo, Ohio, 43615, United States

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Youngstown, Ohio, 44505, United States

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Ashland, Oregon, 97520, United States

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Camp Hill, Pennsylvania, 17011, United States

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Kingston, Pennsylvania, 18704, United States

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Lancaster, Pennsylvania, 17601, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19116, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Columbia, South Carolina, 29223, United States

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Greenville, South Carolina, 29605, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Rapid City, South Dakota, 57701, United States

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Kingsport, Tennessee, 37660, United States

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Nashville, Tennessee, 37203, United States

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Fort Worth, Texas, 76107, United States

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Grapevine, Texas, 76051, United States

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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, United States

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Kingwood, Texas, 77339, United States

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McAllen, Texas, 78503, United States

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Plano, Texas, 75075, United States

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San Antonio, Texas, 78240, United States

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The Woodlands, Texas, 77384, United States

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Salt Lake City, Utah, 84107, United States

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Burlington, Vermont, 05401, United States

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Fairfax, Virginia, 22031, United States

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Warrenton, Virginia, 20186, United States

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Bellevue, Washington, 98004, United States

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Spokane, Washington, 99204, United States

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Morgantown, West Virginia, 26501, United States

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Madison, Wisconsin, 53705, United States

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MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

Exercise; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Avner Ingerman, MD

  Ohr Pharmaceutical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 5, 2016
• Study Start: April 12, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 27, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (118)