Squalamine Lactate Ophthalmic Formulation for Neovascular Age-Related Macular Degeneration
This phase 2 study aims to evaluate how well Squalamine Lactate Ophthalmic Formulation reduces the need for continued concomitant therapy with Lucentis (ranibizumab), the current standard treatment for Neovascular Age-Related Macular Degeneration.
Eye Drops: Squalamine Lactate 0.2%
+ Vehicle Control Eye Drops
Eye Diseases+1
+ Retinal Degeneration
+ Retinal Diseases
Treatment Study
Summary
Study start date: November 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.142 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 20 locations
California Retinal Consultants
Bakersfield, United StatesRetina-Vitreous Associates
Beverly Hilss, United StatesColorado Retina
Golden, United States