Effect of Squalamine Lactate Ophthalmic Solution, 0.2% in Subjects With Neovascular Age-Related Macular Degeneration
NCT ID: NCT02511613
Last Updated: 2017-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2015-07-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution
Placebo Ophthalmic Solution
Placebo Ophthalmic Solution, administered BID
ranibizumab
ranibizumab intravitreal injection
Active
Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2%
Squalamine Lactate Ophthalmic Solution, 0.2%
Squalamine Lactate Ophthalmic Solution, 0.2% administered BID
ranibizumab
ranibizumab intravitreal injection
Interventions
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Squalamine Lactate Ophthalmic Solution, 0.2%
Squalamine Lactate Ophthalmic Solution, 0.2% administered BID
Placebo Ophthalmic Solution
Placebo Ophthalmic Solution, administered BID
ranibizumab
ranibizumab intravitreal injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A diagnosis of choroidal neovascularization secondary to age-related macular degeneration (AMD) with choroidal neovascularization (CNV) comprising at least 50% of the total lesion area in the study eye
* Central retinal thickness ≥ 300 μm and presence of subretinal fluid or cystoid edema by Optical Coherence Tomography (OCT)
* Best Corrected Visual Acuity (BCVA) of 20/40 to 20/320 by Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol
Exclusion Criteria
* Blood occupying greater than 50% of the AMD lesion, or blood \> 1.0 sq. mm underlying the fovea
* 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
50 Years
ALL
No
Sponsors
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Ohr Pharmaceutical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Avner Ingerman, MD
Role: STUDY_DIRECTOR
Ohr Pharmaceutical
Locations
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Investigational Site
Beverly Hills, California, United States
Investigational Site
Hagerstown, Maryland, United States
Investigational Site
New York, New York, United States
Investigational Site
Houston, Texas, United States
Countries
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Other Identifiers
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OHR-1501
Identifier Type: -
Identifier Source: org_study_id
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