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

Age-related Macular Degeneration Clinical Trial

— MAKO  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02727881
• Other study ID #: OHR-1601
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 28, 2016
• Last updated: April 25, 2017
• Start date: April 12, 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Ohr Pharmaceutical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 230
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Squalamine lactate ophthalmic solution, 0.2%
Squalamine lactate ophthalmic solution, 0.2%
• Placebo Ophthalmic solution
Placebo Ophthalmic solution
• ranibizumab
ranibizumab

Locations

Country	Name	City	State
United States	Investigational Site	'Aiea	Hawaii
United States	Investigational Site	Altamonte Springs	Florida
United States	Investigational Site	Arcadia	California
United States	Investigational Site	Ashland	Oregon
United States	Investigational Site	Augusta	Georgia
United States	Investigational Site	Baltimore	Maryland
United States	Investigational Site	Baltimore	Maryland
United States	Investigational Site	Bellevue	Washington
United States	Investigational Site	Berwyn	Illinois
United States	Investigational Site	Beverly Hills	California
United States	Investigational Site	Biloxi	Mississippi
United States	Investigational Site	Bloomfield	New Jersey
United States	Investigational Site	Bloomington	Illinois
United States	Investigational Site	Boynton Beach	Florida
United States	Investigational Site	Bridgeport	Connecticut
United States	Investigational Site	Brooklyn	New York
United States	Investigational Site	Burlington	Vermont
United States	Investigational Site	Camp Hill	Pennsylvania
United States	Investigational Site	Campbell	California
United States	Investigational Site	Charlotte	North Carolina
United States	Investigational Site	Chesterfield	Missouri
United States	Investigational Site	Chicago	Illinois
United States	Investigational Site	Cleveland	Ohio
United States	Investigational Site	Cleveland	Ohio
United States	Investigational Site	Cleveland	Ohio
United States	Investigational Site	Columbia	South Carolina
United States	Investigational Site	Concord	North Carolina
United States	Investigational Site	Detroit	Michigan
United States	Investigational Site	Fairfax	Virginia
United States	Investigational Site	Florissant	Missouri
United States	Investigational Site	Fort Myers	Florida
United States	Investigational Site	Fort Worth	Texas
United States	Investigational Site	Fullerton	California
United States	Investigational Site	Glen Burnie	Maryland
United States	Investigational Site	Glendale	California
United States	Investigational Site	Glendora	California
United States	Investigational Site	Grand Rapids	Michigan
United States	Investigational Site	Grapevine	Texas
United States	Investigational Site	Great Neck	New York
United States	Investigational Site	Greenville	South Carolina
United States	Investigational Site	Hagerstown	Maryland
United States	Investigational Site	Hamden	Connecticut
United States	Investigational Site	Harlingen	Texas
United States	Investigational Site	Hauppauge	New York
United States	Investigational Site	Henderson	Nevada
United States	Investigational Site	Houston	Texas
United States	Investigational Site	Jackson	Michigan
United States	Investigational Site	Katy	Texas
United States	Investigational Site	Kingsport	Tennessee
United States	Investigational Site	Kingston	Pennsylvania
United States	Investigational Site	Kingwood	Texas
United States	Investigational Site	La Jolla	California
United States	Investigational Site	Laguna Hills	California
United States	Investigational Site	Lancaster	Pennsylvania
United States	Investigational Site	Las Vegas	Nevada
United States	Investigational Site	Lawrenceville	New Jersey
United States	Investigational Site	Leawood	Kansas
United States	Investigational Site	Loma Linda	California
United States	Investigational Site	Los Angeles	California
United States	Investigational Site	Louisville	Kentucky
United States	Investigational Site	Lynbrook	New York
United States	Investigational Site	Madison	Wisconsin
United States	Investigational Site	McAllen	Texas
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Mobile	Alabama
United States	Investigational Site	Morgantown	West Virginia
United States	Investigational Site	Mount Pleasant	South Carolina
United States	Investigational Site	Naples	Florida
United States	Investigational Site	Nashville	Tennessee
United States	Investigational Site	New Albany	Indiana
United States	Investigational Site	New Brunswick	New Jersey
United States	Investigational Site	New London	Connecticut
United States	Investigational Site	New York	New York
United States	Investigational Site	New York	New York
United States	Investigational Site	Northfield	New Jersey
United States	Investigational Site	Oceanside	California
United States	Investigational Site	Orange	California
United States	Investigational Site	Paducah	Kentucky
United States	Investigational Site	Palm Desert	California
United States	Investigational Site	Palo Alto	California
United States	Investigational Site	Pasadena	California
United States	Investigational Site	Philadelphia	Pennsylvania
United States	Investigational Site	Philadelphia	Pennsylvania
United States	Investigational Site	Philadelphia	Pennsylvania
United States	Investigational Site	Phoenix	Arizona
United States	Investigational Site	Phoenix	Arizona
United States	Investigational Site	Phoenix	Arizona
United States	Investigational Site	Pikesville	Maryland
United States	Investigational Site	Pittsburgh	Pennsylvania
United States	Investigational Site	Plano	Texas
United States	Investigational Site	Portland	Maine
United States	Investigational Site	Portsmouth	New Hampshire
United States	Investigational Site	Poway	California
United States	Investigational Site	Ramsey	New Jersey
United States	Investigational Site	Rapid City	South Dakota
United States	Investigational Site	Redlands	California
United States	Investigational Site	Rochester	New York
United States	Investigational Site	Rockville	Maryland
United States	Investigational Site	Rockville Centre	New York
United States	Investigational Site	Royal Oak	Michigan
United States	Investigational Site	Sacramento	California
United States	Investigational Site	Salt Lake City	Utah
United States	Investigational Site	San Antonio	Texas
United States	Investigational Site	Sarasota	Florida
United States	Investigational Site	Southfield	Michigan
United States	Investigational Site	Spokane	Washington
United States	Investigational Site	Stuart	Florida
United States	Investigational Site	Sycamore	Illinois
United States	Investigational Site	Syracuse	New York
United States	Investigational Site	Teaneck	New Jersey
United States	Investigational Site	The Woodlands	Texas
United States	Investigational Site	Toledo	Ohio
United States	Investigational Site	Toms River	New Jersey
United States	Investigational Site	Traverse City	Michigan
United States	Investigational Site	Tucson	Arizona
United States	Investigational Site	Warrenton	Virginia
United States	Investigational Site	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohr Pharmaceutical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment emergent Adverse Event (AE) monitoring	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	9 months
Primary	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	Functional changes 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