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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohr Pharmaceutical Inc.
• Treatments: Ophthalmic Solutions; Squalamine; Tetrahydrozoline

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.