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

NCT01678963 | Completed Phase 2

• 1 other identifier: OHR-002
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Neovascular Age Related Macular Degeneration

Keywords

Neovascular AMD; Wet AMD; AMD; Age related macular degeneration

Outcome Measures

Primary Outcomes (1)

• Need for continued concomitant therapy

  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.

  9 months

Secondary Outcomes (2)

• Best Corrected Visual Acuity (BCVA)

  9 months

• Number of subjects with adverse events as a measure of safety and tolerability

  9 months

Study Arms (2)

Squalamine

EXPERIMENTAL

Squalamine eye drop 0.2%

Drug: Squalamine lactate

Vehicle Control

PLACEBO COMPARATOR

Eye drop vehicle control

Drug: Vehicle control

Interventions

Squalamine lactate DRUG

Ophthalmic solution 0.2%

Squalamine

Vehicle control DRUG

Ophthalmic solution vehicle control

Vehicle Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ohr Pharmaceutical Inc.: lead

Study Sites (20)

Retina Associates SW

Tucson, Arizona, 85710, United States

Location

California Retinal Consultants

Bakersfield, California, 93309, United States

Location

Retina-Vitreous Associates

Beverly Hilss, California, 90211, United States

Location

Colorado Retina

Golden, Colorado, 80401, United States

Location

Florida Eye Microsurgical Institute Inc.

Boynton Beach, Florida, 33426, United States

Location

Retina Health Center

Fort Myers, Florida, 33907, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

Elman Retina

Baltimore, Maryland, 21237, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Vision Research Foundation

Grand Rapids, Michigan, 49546, United States

Location

Vision Research Foundation

Royal Oak, Michigan, 48073, United States

Location

Vision Research Foundation

Traverse City, Michigan, 49686, United States

Location

Total Practice Management

New Brunswick, New Jersey, 08901, United States

Location

Macula Care

New York, New York, 10021, United States

Location

Retina Associates of Cleveland

Cleveland, Ohio, 44122, United States

Location

PA Retina

Camp Hill, Pennsylvania, 17011, United States

Location

TN Retina

Nashville, Tennessee, 37203, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

squalamine lactate

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: September 5, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 12, 2015

Record last verified: 2015-06

Locations

US (20)