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

Primary Purpose

Age-Related Macular Degeneration

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Squalamine Lactate Ophthalmic Solution, 0.2%
Placebo Ophthalmic Solution
ranibizumab
Sponsored by
Ohr Pharmaceutical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Active

Arm Description

Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution

Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2%

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 27, 2015
Last Updated
April 25, 2017
Sponsor
Ohr Pharmaceutical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02511613
Brief Title
Effect of Squalamine Lactate Ophthalmic Solution, 0.2% in Subjects With Neovascular Age-Related Macular Degeneration
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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Company decision
Study Start Date
July 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohr Pharmaceutical Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution
Arm Title
Active
Arm Type
Active Comparator
Arm Description
Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2%
Intervention Type
Drug
Intervention Name(s)
Squalamine Lactate Ophthalmic Solution, 0.2%
Other Intervention Name(s)
Squalamine
Intervention Description
Squalamine Lactate Ophthalmic Solution, 0.2% administered BID
Intervention Type
Drug
Intervention Name(s)
Placebo Ophthalmic Solution
Other Intervention Name(s)
Placebo
Intervention Description
Placebo Ophthalmic Solution, administered BID
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
ranibizumab intravitreal injection
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avner Ingerman, MD
Organizational Affiliation
Ohr Pharmaceutical
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Investigational Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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