Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 in Treating DryAge-Related Macular Degeneration

MacuCLEAR, Inc.60 enrolled

Overview

This is a Phase II/III,vehicle controlled, double masked, single center study. A single eye of 60 individuals with mild to moderate non-exudative Age-Related Macular Degeneration (AMD) will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2 years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for these patients. An analysis of the primary and secondary endpoints will be conducted when all subjects have completed Baseline, 1, 3, 6, 12,18 and 24 months.

MC-1101is a topically administered drug which in previous clinical studies has been proven to get to the back of the eye. MC-1101is a 505 (b) 2 compound and has FDA Fast Track Status. It is a strong, vasoactive drug which is intended to increase choroidal blood flow.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Non-Exudative Age Related Macular Degeneration

Interventions

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females age ≥ 50 years and ≤ 85 years * Females only: At least 1year since last menstrual period or surgically sterilized * 20/80 or better ETDRS best corrected visual acuity * Early to intermediate nonexudative AMD (AMD category 3 through 3b on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories * Willing and able to sign informed consent, comply with study protocol requirements, and undergo at least 2.5 hours of testing at each visit * Able to reliably to complete biophysical testing * Willing to take an AREDS2 based formula vitamin as indicated Exclusion Criteria: * Past or current exudative AMD or central geographic atrophy in study eye; (AMD Category 4 on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories) * Past or current retinal or choroidal vasculopathy in study eye (e.g. serous or hemorrhagic pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous chorioretinopathy, retinal vein occlusion, sickle cell retinopathy) * Uncontrolled hypertension (≥ 160 systolic or ≥95 diastolic) * Glaucoma * Dilated pupil diameter less than 6 millimeters * Subjects with a history of a hypersensitivity reaction to the study drug or to any agent used in the components of the study assessment * Use of topical ocular medications (other than artificial tear products) * Anticipated extra- or intraocular intervention during the study period * High myopia (refractive error spherical equivalent ≥ -6 diopters) * Optic neuropathy * Neurological conditions that can impair vision (e.g. Parkinson's disease, multiple sclerosis, Alzheimer's disease) * Liver disease (e.g. cirrhosis, hepatitis) * History of small bowel surgery * Current or past use for more than 30 days of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazimine, cisplatin, carmustine (BCNU), deferoxamine, amiodorone, isoretinoin, or gold * Contact lens wearers (not prepared to discontinue lens use) * Ophthalmic surgery of any kind within 3 months prior to screening visit * Participation in any interventional clinical study requiring IRB approval within 3 months prior to screening visit of this study * Currently being treated for cancer or any disease likely to adversely affect participation in a 2 year study * Known to have AIDS/HIV * Current use of hydralazine * Any other findings deemed unacceptable by the Principal Investigator or Sponsor

Outcomes

Primary Outcomes

Visual Function

Primary efficacy assessment will be a comparison between groups of the change in visual function at 12 months with additional analyses at 18 and 24 months measured by dark adaptation methodology.

Time frame: Up to 24 months

Secondary Outcomes

Safety and tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia)

Evaluate the safety and tolerability (incidence and severity of adverse events, ocular irritability and ocular hyperemia) of MC-1101compared to a vehicle control at each study visit following treatment for 2 years.