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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ohr Pharmaceutical Inc.
ClinicalTrials.gov Identifier:
NCT01678963
First received: August 27, 2012
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Neovascular Age Related Macular Degeneration
Drug: Squalamine lactate
Drug: Vehicle control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Formulation 0.2% BID in Subjects With Neovascular AMD.

Resource links provided by NLM:


Further study details as provided by Ohr Pharmaceutical Inc.:

Primary Outcome Measures:
  • Need for continued concomitant therapy [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Squalamine
Squalamine eye drop 0.2%
Drug: Squalamine lactate
Ophthalmic solution 0.2%
Placebo Comparator: Vehicle Control
Eye drop vehicle control
Drug: Vehicle control
Ophthalmic solution vehicle control

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678963

Locations
United States, Arizona
Retina Associates SW
Tucson, Arizona, United States, 85710
United States, California
California Retinal Consultants
Bakersfield, California, United States, 93309
Retina-Vitreous Associates
Beverly Hilss, California, United States, 90211
United States, Colorado
Colorado Retina
Golden, Colorado, United States, 80401
United States, Florida
Florida Eye Microsurgical Institute Inc.
Boynton Beach, Florida, United States, 33426
Retina Health Center
Fort Myers, Florida, United States, 33907
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
United States, Maryland
Elman Retina
Baltimore, Maryland, United States, 21237
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Michigan
Vision Research Foundation
Grand Rapids, Michigan, United States, 49546
Vision Research Foundation
Royal Oak, Michigan, United States, 48073
Vision Research Foundation
Traverse City, Michigan, United States, 49686
United States, New Jersey
Total Practice Management
New Brunswick, New Jersey, United States, 08901
United States, New York
Macula Care
New York, New York, United States, 10021
United States, Ohio
Retina Associates of Cleveland
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
PA Retina
Camp Hill, Pennsylvania, United States, 17011
United States, Tennessee
TN Retina
Nashville, Tennessee, United States, 37203
United States, Texas
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Ohr Pharmaceutical Inc.
  More Information

No publications provided

Responsible Party: Ohr Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT01678963     History of Changes
Other Study ID Numbers: OHR-002
Study First Received: August 27, 2012
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohr Pharmaceutical Inc.:
Neovascular AMD
Wet AMD
AMD
Age related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Eye Diseases
Squalamine
Retinal Degeneration
Retinal Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014