Clinical trial NCT02727881: Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Age-related Macular Degeneration
Keywords: AMD, CNV, choroidal neovascularization, retinal eye disease
Lead sponsor: Ohr Pharmaceutical Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-05
Enrollment: 230
Sex: ALL
Minimum age (years): 50
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Functional change in visual acuity
timeFrame: 9 months
Secondary outcomes:
measure: Functional changes in visual acuity
timeFrame: 9 months
Other outcomes:
measure: Treatment emergent Adverse Event (AE) monitoring
timeFrame: 9 months
Locations:
city: Mobile
country: United States
facility: Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Investigational Site
state: Arizona
city: Arcadia
country: United States
facility: Investigational Site
state: California
city: Beverly Hills
country: United States
facility: Investigational Site
state: California
city: Campbell
country: United States
facility: Investigational Site
state: California
city: Fullerton
country: United States
facility: Investigational Site
state: California
city: Glendale
country: United States
facility: Investigational Site
state: California
city: Glendora
country: United States
facility: Investigational Site
state: California
city: La Jolla
country: United States
facility: Investigational Site
state: California
city: Laguna Hills
country: United States
facility: Investigational Site
state: California
city: Loma Linda
country: United States
facility: Investigational Site
state: California
city: Los Angeles
country: United States
facility: Investigational Site
state: California
city: Oceanside
country: United States
facility: Investigational Site
state: California
city: Orange
country: United States
facility: Investigational Site
state: California
city: Palm Desert
country: United States
facility: Investigational Site
state: California
city: Palo Alto
country: United States
facility: Investigational Site
state: California
city: Pasadena
country: United States
facility: Investigational Site
state: California
city: Poway
country: United States
facility: Investigational Site
state: California
city: Redlands
country: United States
facility: Investigational Site
state: California
city: Sacramento
country: United States
facility: Investigational Site
state: California
city: Bridgeport
country: United States
facility: Investigational Site
state: Connecticut
city: Hamden
country: United States
facility: Investigational Site
state: Connecticut
city: New London
country: United States
facility: Investigational Site
state: Connecticut
city: Altamonte Springs
country: United States
facility: Investigational Site
state: Florida
city: Boynton Beach
country: United States
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state: Florida
city: Fort Myers
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Naples
country: United States
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state: Florida
city: Sarasota
country: United States
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state: Florida
city: Stuart
country: United States
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state: Florida
city: Augusta
country: United States
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state: Georgia
city: 'Aiea
country: United States
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state: Hawaii
city: Berwyn
country: United States
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state: Illinois
city: Bloomington
country: United States
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state: Illinois
city: Chicago
country: United States
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state: Illinois
city: Sycamore
country: United States
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state: Illinois
city: New Albany
country: United States
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state: Indiana
city: Leawood
country: United States
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state: Kansas
city: Louisville
country: United States
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state: Kentucky
city: Paducah
country: United States
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state: Kentucky
city: Portland
country: United States
facility: Investigational Site
state: Maine
city: Baltimore
country: United States
facility: Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Investigational Site
state: Maryland
city: Glen Burnie
country: United States
facility: Investigational Site
state: Maryland
city: Hagerstown
country: United States
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state: Maryland
city: Pikesville
country: United States
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state: Maryland
city: Rockville
country: United States
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state: Maryland
city: Detroit
country: United States
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state: Michigan
city: Grand Rapids
country: United States
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state: Michigan
city: Jackson
country: United States
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state: Michigan
city: Royal Oak
country: United States
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state: Michigan
city: Southfield
country: United States
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state: Michigan
city: Traverse City
country: United States
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state: Michigan
city: Biloxi
country: United States
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state: Mississippi
city: Chesterfield
country: United States
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state: Missouri
city: Florissant
country: United States
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state: Missouri
city: Henderson
country: United States
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state: Nevada
city: Las Vegas
country: United States
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state: Nevada
city: Portsmouth
country: United States
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state: New Hampshire
city: Bloomfield
country: United States
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state: New Jersey
city: Lawrenceville
country: United States
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state: New Jersey
city: New Brunswick
country: United States
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state: New Jersey
city: Northfield
country: United States
facility: Investigational Site
state: New Jersey
city: Ramsey
country: United States
facility: Investigational Site
state: New Jersey
city: Teaneck
country: United States
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state: New Jersey
city: Toms River
country: United States
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state: New Jersey
city: Brooklyn
country: United States
facility: Investigational Site
state: New York
city: Great Neck
country: United States
facility: Investigational Site
state: New York
city: Hauppauge
country: United States
facility: Investigational Site
state: New York
city: Lynbrook
country: United States
facility: Investigational Site
state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
facility: Investigational Site
state: New York
city: Rochester
country: United States
facility: Investigational Site
state: New York
city: Rockville Centre
country: United States
facility: Investigational Site
state: New York
city: Syracuse
country: United States
facility: Investigational Site
state: New York
city: Charlotte
country: United States
facility: Investigational Site
state: North Carolina
city: Concord
country: United States
facility: Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Investigational Site
state: Ohio
city: Cleveland
country: United States
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state: Ohio
city: Toledo
country: United States
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state: Ohio
city: Youngstown
country: United States
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state: Ohio
city: Ashland
country: United States
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state: Oregon
city: Camp Hill
country: United States
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state: Pennsylvania
city: Kingston
country: United States
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state: Pennsylvania
city: Lancaster
country: United States
facility: Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Columbia
country: United States
facility: Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Investigational Site
state: South Carolina
city: Rapid City
country: United States
facility: Investigational Site
state: South Dakota
city: Kingsport
country: United States
facility: Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Investigational Site
state: Tennessee
city: Fort Worth
country: United States
facility: Investigational Site
state: Texas
city: Grapevine
country: United States
facility: Investigational Site
state: Texas
city: Harlingen
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: Katy
country: United States
facility: Investigational Site
state: Texas
city: Kingwood
country: United States
facility: Investigational Site
state: Texas
city: McAllen
country: United States
facility: Investigational Site
state: Texas
city: Plano
country: United States
facility: Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Investigational Site
state: Texas
city: The Woodlands
country: United States
facility: Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Investigational Site
state: Utah
city: Burlington
country: United States
facility: Investigational Site
state: Vermont
city: Fairfax
country: United States
facility: Investigational Site
state: Virginia
city: Warrenton
country: United States
facility: Investigational Site
state: Virginia
city: Bellevue
country: United States
facility: Investigational Site
state: Washington
city: Spokane
country: United States
facility: Investigational Site
state: Washington
city: Morgantown
country: United States
facility: Investigational Site
state: West Virginia
city: Madison
country: United States
facility: Investigational Site
state: Wisconsin
Study officials:
affiliation: Ohr Pharmaceutical
name: Avner Ingerman, MD
role: STUDY_DIRECTOR
References: