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

This study is currently recruiting participants.
Verified January 2013 by Ohr Pharmaceutical Inc.
Sponsor:
Information provided by (Responsible Party):
Ohr Pharmaceutical Inc.
ClinicalTrials.gov Identifier:
NCT01678963
First received: August 27, 2012
Last updated: January 21, 2013
Last verified: January 2013
  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: March 2014
Estimated Primary Completion Date: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678963

Contacts
Contact: Irach B Taraporewala, PhD 212-682-8452 itaraporewala@ohrpharmaceutical.com

Locations
United States, Arizona
Retina Associates SW Recruiting
Tucson, Arizona, United States, 85710
Contact: Rita Lennon    530-733-8584    research@retinatucson.com   
Principal Investigator: Mark Walsh, MD         
United States, California
California Retinal Consultants Recruiting
Bakersfield, California, United States, 93309
Contact: Jack Giust    661-325-4393    crcjgiust@yahoo.com   
Contact: Mel Rabena    805-963-1648    mdrabena@yahoo.com   
Principal Investigator: Alessandro Castellarin, MD         
Retina-Vitreous Associates Recruiting
Beverly Hilss, California, United States, 90211
Contact: Cassandra Gonzalez    310-289-2478 ext 3    CGonzalez@laretina.com   
Contact: Connie Hoang    310-289-2478 ext 1241    Choang@laretina.com   
Principal Investigator: David Boyer, MD         
United States, Colorado
Colorado Retina Recruiting
Golden, Colorado, United States, 80401
Contact: Cassandra Catlett    303-261-1600 ext 1429    ccatlett@retinacolorado.com   
Principal Investigator: David Johnson         
United States, Florida
Florida Eye Microsurgical Institute Inc. Recruiting
Boynton Beach, Florida, United States, 33426
Contact: Debbie Rankin, MD    561-736-5055    drankin@fleyedocs.com   
Principal Investigator: Randy Katz, MD         
Retina Health Center Recruiting
Fort Myers, Florida, United States, 33907
Contact: Christine Elkins    239-337-3337 ext 220    Christine.Elkins@retinahealthcenter.com   
Principal Investigator: Alex Eaton, MD         
United States, Indiana
Midwest Eye Institute Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Ashley Stephenson    317-805-2195    ashleys@midwesteye.com   
Contact: Bethany Sink    317-805-2150    bethanys@midwesteye.com   
Principal Investigator: Thomas Ciulla         
United States, Maryland
Elman Retina Recruiting
Baltimore, Maryland, United States, 21237
Contact: JoAnn Starr    410-686-3394    starr@elmanretina.com   
Principal Investigator: Michael Elman, MD         
Cumberland Valley Retina Consultants Recruiting
Hagerstown, Maryland, United States, 21740
Contact: Alison Carbaugh    301-665-1712 ext 205    alisonc@retinacare.net   
Principal Investigator: John Wroblewski, MD         
United States, Massachusetts
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jeremy Schindelheim    617-314-2608    jschindelheim@eyeboston.com   
Contact: Alison Nowak    617-723-7028    anowak@eyeboston.com   
Principal Investigator: Jeffrey S Heier         
United States, Michigan
Vision Research Foundation Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Deb Markus    616-942-2406 ext 1720    dmarkus@arcpc.net   
Principal Investigator: Alan Margherio, MD         
Vision Research Foundation Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Mary Zajechowski    248-288-9132 ext 1333    maryz@arcpc.net   
Principal Investigator: Antonio Capone, MD         
Sub-Investigator: Lisa Faia, MD         
Vision Research Foundation Recruiting
Traverse City, Michigan, United States, 49686
Contact: Julie Darling    231-938-0710    Jhammersley@arcpc.net   
Principal Investigator: Kean Oh, MD         
United States, New Jersey
Total Practice Management Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Robyn Rhams    732-220-1600    rrhams@retinanj.com   
Contact: Starr Muscle    732-220-1600    smuscle@retinanj.com   
Principal Investigator: Daniel Roth         
United States, New York
Macula Care Recruiting
New York, New York, United States, 10021
Contact: Miriam Madry    212-439-9600    miriam@maculacare.com   
Principal Investigator: Daniel Rosberger, MD         
United States, Ohio
Retina Associates of Cleveland Recruiting
Cleveland, Ohio, United States, 44122
Contact: Vivian Tanner    216-831-5704    vtanner@retina-assoc.com   
Principal Investigator: Larry Singerman         
United States, Pennsylvania
PA Retina Recruiting
Camp Hill, Pennsylvania, United States, 17011
Contact: Julia Teatsworth    717-761-8688 ext 212    Jateatsworth@paretina.com   
Principal Investigator: Jay Prensky, MD         
United States, Tennessee
TN Retina Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sarah Hines    615-983-6000    shines@tnretina.com   
Principal Investigator: Trent Wallace         
United States, Texas
Medical Center Ophthalmology Associates Recruiting
San Antonio, Texas, United States, 78240
Contact: Cathy Ellis    210-697-2036 ext 2270      
Contact: Beatrice Guajardo    210-697-2036 ext 2239      
Principal Investigator: Michael Singer, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Kris Dietzman    608-265-4659    kadietzman@ophth.wisc.edu   
Contact: Jennie Perry-Raymond    608-265-4659    jrperry@ophth.wisc.edu   
Principal Investigator: Michael Ip, MD         
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: January 21, 2013
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
Retinal Degeneration
Retinal Diseases
Eye Diseases
Squalamine
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 April 17, 2014