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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 1.0% BID in the Treatment of Non-exudative Age-Related Macular Degeneration

Conditions
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Non-Exudative Age Related Macular Degeneration

Intervention / Treatment
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* Drug: MC-1101
* Drug: MC-1101 Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MC-1101 active<br>Topical Drug 1% Ophthalmic Solution Topically, two times per day; morning and bedtime | Drug: MC-1101<br>* Topically, two times a day, morning and bedtime<br>* Other names: 1% Ophthalmic Solution;|
| Placebo Comparator: MC-1101 Vehicle Control<br>Topical Drug: Ophthalmic Solution Topically, two times per day; morning and bedtime | Drug: MC-1101 Vehicle<br>* Topically, two times a day; morning and bedtime<br>* Other names: Topical Ophthalmic Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, Dry AMD, Non-Exudative AMD, MC-1101