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Effect of Squalamine Lactate Ophthalmic Solution, 0.2% in Subjects With Neovascular Age-Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT02511613
Recruitment Status : Withdrawn (Company decision)
First Posted : July 30, 2015
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ohr Pharmaceutical Inc.

Brief Summary:
The purpose of this study is to evaluate anatomical and functional effect of combination therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Squalamine Lactate Ophthalmic Solution, 0.2% Drug: Placebo Ophthalmic Solution Drug: ranibizumab Phase 2

Detailed Description:
Subjects with age-related macular degeneration who meet inclusion and exclusion criteria will be randomized to receive monthly intravitreal injections of ranibizumab (Lucentis®) with either Squalamine Lactate Ophthalmic solution 0.2% or placebo eye drops twice a day for 6 months. Subjects will be evaluated with clinical and imaging techniques.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study of Safety, Functional and Anatomical Effect of Squalamine Lactate Ophthalmic Solution, 0.2% Administered Twice Daily in Subjects With Neovascular Age-related Macular Degeneration
Study Start Date : July 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution
Drug: Placebo Ophthalmic Solution
Placebo Ophthalmic Solution, administered BID
Other Name: Placebo

Drug: ranibizumab
ranibizumab intravitreal injection
Other Name: Lucentis®

Active Comparator: Active
Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2%
Drug: Squalamine Lactate Ophthalmic Solution, 0.2%
Squalamine Lactate Ophthalmic Solution, 0.2% administered BID
Other Name: Squalamine

Drug: ranibizumab
ranibizumab intravitreal injection
Other Name: Lucentis®




Primary Outcome Measures :
  1. Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on anatomy and function as assessed by retinal imaging and ETDRS BCVA in subjects with Age-Related Macular Degeneration [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 50 years of age or older
  • 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:

  • 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
  • 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

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): NCT02511613


Locations
United States, California
Investigational Site
Beverly Hills, California, United States, 90211
United States, Maryland
Investigational Site
Hagerstown, Maryland, United States, 21740
United States, New York
Investigational Site
New York, New York, United States, 10022
United States, Texas
Investigational Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Ohr Pharmaceutical Inc.
Investigators
Study Director: Avner Ingerman, MD Ohr Pharmaceutical

Responsible Party: Ohr Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT02511613     History of Changes
Other Study ID Numbers: OHR-1501
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Squalamine
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pharmaceutical Solutions
Ranibizumab
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