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:
Ohr Pharmaceutical Inc.
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
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
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 May 19, 2013