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

Completed · Phase 2

Conditions studied: Neovascular Age Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT01678963

Run by

Ohr Pharmaceutical Inc.

People needed

142

Starts

2012-11-01

Expected to finish

2015-03-01

Last updated by the study team

2015-06-12

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• 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.

Where it is running

• Retina Associates SW — Tucson, Arizona, United States
• California Retinal Consultants — Bakersfield, California, United States
• Retina-Vitreous Associates — Beverly Hilss, California, United States
• Colorado Retina — Golden, Colorado, United States
• Florida Eye Microsurgical Institute Inc. — Boynton Beach, Florida, United States
• Retina Health Center — Fort Myers, Florida, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• Elman Retina — Baltimore, Maryland, United States
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• Vision Research Foundation — Grand Rapids, Michigan, United States
• Vision Research Foundation — Royal Oak, Michigan, United States
• Vision Research Foundation — Traverse City, Michigan, United States
• Total Practice Management — New Brunswick, New Jersey, United States
• Macula Care — New York, New York, United States
• Retina Associates of Cleveland — Cleveland, Ohio, United States
• PA Retina — Camp Hill, Pennsylvania, United States
• TN Retina — Nashville, Tennessee, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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