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Efficacy and Safety of Squalamine Lactate Eye Drops in Subjects With Neovascular (Wet) Age-related Macular Degeneration (AMD)

Primary Purpose

Neovascular Age Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Squalamine lactate
Vehicle control
Sponsored by
Ohr Pharmaceutical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age Related Macular Degeneration focused on measuring Neovascular AMD, Wet AMD, AMD, Age related macular degeneration

Eligibility Criteria

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

Inclusion Criteria:

  • ≥50 years of age, male or female

  • Have the following criteria in the study eye:

    • A diagnosis of choroidal neovascularization secondary to AMD with total lesion area ≤ 12 disc areas with CNV affecting at least 50% of the total lesion area, in at least one eye confirmed by fluorescein angiography (via the reading center)
    • Central Retinal Thickness (SD- OCT central 1 mm) of ≥ 300 um
    • Presence of sub-retinal fluid or cystoid edema on OCT. Pigment epithelial detachments without subretinal fluid or cystoid edema will be excluded
    • BCVA 20/40 to 20/230 (25 to 70 letters ETDRS)
    • If both eyes qualify the eye with the greater CRT will be the study eye. If both equal the right eye will be selected as the study eye.
  • Female subjects must be 1-year postmenopausal or surgically sterilized, Women of childbearing potential must have a negative urine pregnancy test and must use an acceptable method of contraception throughout the study.
  • Be willing and able to provide signed informed consent prior to participation in any study-related procedures.

Exclusion Criteria:

  • Neovascularization secondary to any condition other than AMD in the study eye.
  • Blood occupying greater than 50% of the AMD lesion. Blood underlying the fovea.
  • Prior treatment in the study eye with bevacizumab, ranibizumab, aflibercept, PDT, submacular surgery, any antiangiogenic drug.
  • Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance eg: cataract.
  • Subjects with VA worse than 20/200 (less than 34 letters) in the fellow (non-study) eye.
  • Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement.
  • Prior ocular surgery in the study eye (Vitrectomy, scleral buckle, or glaucoma filter/shunt). Cataract surgery more than 3 months prior to enrollment is allowed so long as a posterior chamber intraocular lens is in place.
  • Wearing contact lenses.
  • Concomitant therapy with any drug that may affect VA, meds that may be toxic to the lens/retina or optic nerve.
  • Current ocular or periocular infection in the study eye.
  • Hypersensitivity to Lucentis.
  • Hypersensitivity to squalamine or any component of the ophthalmic formulation
  • Presence of a life threatening disease or currently on treatment for a malignancy.
  • Currently on chemotherapy.
  • Currently on systemic steroids.
  • Pregnant or lactating.
  • Investigational product use of any kind in the previous 30 days.
  • Subjects for whom attendance for monthly examinations may be unreliable eg: dependent on an elderly caregiver.
  • Glaucoma in the study eye (glaucomatous visual field defect and receiving treatment).
  • Myocardial infarction or cerebrovascular accident or transient ischemic attacks (TIA) within the past 6 months.
  • Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye.
  • Uncontrolled hypertension (Diastolic BP >105 mmHg) in spite of antihypertensive medications.
  • Subjects known to have HIV.
  • A history of drug or alcohol abuse.
  • Subjects unable to administer eye drops reliably.

Sites / Locations

  • Retina Associates SW
  • California Retinal Consultants
  • Retina-Vitreous Associates
  • Colorado Retina
  • Florida Eye Microsurgical Institute Inc.
  • Retina Health Center
  • Midwest Eye Institute
  • Elman Retina
  • Cumberland Valley Retina Consultants
  • Ophthalmic Consultants of Boston
  • Vision Research Foundation
  • Vision Research Foundation
  • Vision Research Foundation
  • Total Practice Management
  • Macula Care
  • Retina Associates of Cleveland
  • PA Retina
  • TN Retina
  • Medical Center Ophthalmology Associates
  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Squalamine

Vehicle Control

Arm Description

Squalamine eye drop 0.2%

Eye drop vehicle control

Outcomes

Primary Outcome Measures

Need for continued concomitant therapy
Lucentis (ranibizumab) is the current standard of care for the treatment of wet AMD. All patients will receive an initial injection of Lucentis prior to randomization and then be evaluated monthly for their need for further Lucentis injections using protocol defined retreatment criteria.

Secondary Outcome Measures

Best Corrected Visual Acuity (BCVA)
Evaluation of the effect of treatment on visual function (BCVA) as measured using the EDTRS chart measured at an initial distance of 4 meters.
Number of subjects with adverse events as a measure of safety and tolerability
The frequency, severity, seriousness of all adverse events including their relationship to study drug and effect on discontinuation from the study will be monitored, recorded and analysed.

Full Information

First Posted
August 27, 2012
Last Updated
June 11, 2015
Sponsor
Ohr Pharmaceutical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01678963
Brief Title
Efficacy and Safety of Squalamine Lactate Eye Drops in Subjects With Neovascular (Wet) Age-related Macular Degeneration (AMD)
Official Title
Phase II Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Formulation 0.2% BID in Subjects With Neovascular AMD.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

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 the safety and efficacy of topical ophthalmic squalamine lactate eye drops in treating patients with neovascular age-related macular degeneration (wet AMD), a degenerative retinal eye disease that causes a progressive, irreversible, severe loss of central vision.
Detailed Description
Age-related macular degeneration (AMD) is a degenerative retinal eye disease that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world and affects 25-30 million people globally. This number is expected to triple over the next 25 years. Central vision loss from AMD is caused by the degeneration of light-sensing cells in the macula called photoreceptors. The macula, the central portion of the retina, is responsible for perceiving fine visual detail. As photoreceptors begin to degenerate, so does the individual's central vision. The extent of vision loss varies widely and is related to the type of AMD, its severity and other individual characteristics. AMD presents itself in two different forms - a "dry" form and the more severe "wet" form. Dry AMD, the more common and milder form of AMD, accounts for 85% to 90% of all cases. It results in varying forms of sight loss and may or may not eventually develop into the wet form. Although the wet form of AMD accounts for only 10% to 15% of all AMD, the chance for severe sight loss is much greater. Wet AMD is responsible for 90% of severe vision loss associated with AMD. Approximately 500,000 new cases of wet AMD are diagnosed annually worldwide. In North America alone, approximately 200,000 new cases of wet AMD are diagnosed each year. Squalamine lactate has been found to be an inhibitor of new blood vessel formation (angiogenesis) induced by VEGF, PDGF or bFGF. Since angiogenesis is implicated in the growth and maintenance of choroidal neovascularization, squalamine lactate is potentially an attractive development candidate in the treatment of age-related macular degeneration (AMD), in which blood vessel proliferation has a role.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age Related Macular Degeneration
Keywords
Neovascular AMD, Wet AMD, AMD, Age related macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Squalamine
Arm Type
Experimental
Arm Description
Squalamine eye drop 0.2%
Arm Title
Vehicle Control
Arm Type
Placebo Comparator
Arm Description
Eye drop vehicle control
Intervention Type
Drug
Intervention Name(s)
Squalamine lactate
Intervention Description
Ophthalmic solution 0.2%
Intervention Type
Drug
Intervention Name(s)
Vehicle control
Intervention Description
Ophthalmic solution vehicle control
Primary Outcome Measure Information:
Title
Need for continued concomitant therapy
Description
Lucentis (ranibizumab) is the current standard of care for the treatment of wet AMD. All patients will receive an initial injection of Lucentis prior to randomization and then be evaluated monthly for their need for further Lucentis injections using protocol defined retreatment criteria.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Best Corrected Visual Acuity (BCVA)
Description
Evaluation of the effect of treatment on visual function (BCVA) as measured using the EDTRS chart measured at an initial distance of 4 meters.
Time Frame
9 months
Title
Number of subjects with adverse events as a measure of safety and tolerability
Description
The frequency, severity, seriousness of all adverse events including their relationship to study drug and effect on discontinuation from the study will be monitored, recorded and analysed.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥50 years of age, male or female Have the following criteria in the study eye: A diagnosis of choroidal neovascularization secondary to AMD with total lesion area ≤ 12 disc areas with CNV affecting at least 50% of the total lesion area, in at least one eye confirmed by fluorescein angiography (via the reading center) Central Retinal Thickness (SD- OCT central 1 mm) of ≥ 300 um Presence of sub-retinal fluid or cystoid edema on OCT. Pigment epithelial detachments without subretinal fluid or cystoid edema will be excluded BCVA 20/40 to 20/230 (25 to 70 letters ETDRS) If both eyes qualify the eye with the greater CRT will be the study eye. If both equal the right eye will be selected as the study eye. Female subjects must be 1-year postmenopausal or surgically sterilized, Women of childbearing potential must have a negative urine pregnancy test and must use an acceptable method of contraception throughout the study. Be willing and able to provide signed informed consent prior to participation in any study-related procedures. Exclusion Criteria: Neovascularization secondary to any condition other than AMD in the study eye. Blood occupying greater than 50% of the AMD lesion. Blood underlying the fovea. Prior treatment in the study eye with bevacizumab, ranibizumab, aflibercept, PDT, submacular surgery, any antiangiogenic drug. Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance eg: cataract. Subjects with VA worse than 20/200 (less than 34 letters) in the fellow (non-study) eye. Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement. Prior ocular surgery in the study eye (Vitrectomy, scleral buckle, or glaucoma filter/shunt). Cataract surgery more than 3 months prior to enrollment is allowed so long as a posterior chamber intraocular lens is in place. Wearing contact lenses. Concomitant therapy with any drug that may affect VA, meds that may be toxic to the lens/retina or optic nerve. Current ocular or periocular infection in the study eye. Hypersensitivity to Lucentis. Hypersensitivity to squalamine or any component of the ophthalmic formulation Presence of a life threatening disease or currently on treatment for a malignancy. Currently on chemotherapy. Currently on systemic steroids. Pregnant or lactating. Investigational product use of any kind in the previous 30 days. Subjects for whom attendance for monthly examinations may be unreliable eg: dependent on an elderly caregiver. Glaucoma in the study eye (glaucomatous visual field defect and receiving treatment). Myocardial infarction or cerebrovascular accident or transient ischemic attacks (TIA) within the past 6 months. Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye. Uncontrolled hypertension (Diastolic BP >105 mmHg) in spite of antihypertensive medications. Subjects known to have HIV. A history of drug or alcohol abuse. Subjects unable to administer eye drops reliably.
Facility Information:
Facility Name
Retina Associates SW
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
California Retinal Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Retina-Vitreous Associates
City
Beverly Hilss
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Colorado Retina
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Florida Eye Microsurgical Institute Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Retina Health Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Elman Retina
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Vision Research Foundation
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Vision Research Foundation
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Vision Research Foundation
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49686
Country
United States
Facility Name
Total Practice Management
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Macula Care
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Retina Associates of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
PA Retina
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
TN Retina
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

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Efficacy and Safety of Squalamine Lactate Eye Drops in Subjects With Neovascular (Wet) Age-related Macular Degeneration (AMD)

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