Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
This is a Phase II/III vehicle controlled, double masked, single center study. A single eye of 60 individuals with mild to moderate nonexudative 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 12, 18 and 24 months.

Official Title
-----------------
Phase II/III Study of the Efficacy and Safety of Macuclear MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration

Conditions
-----------------
Nonexudative Age Related Macular Degeneration

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females age ≥ 50 years and ≤ 85 years; Females must be at least 1 year postmenopausal (after last menstrual period) or sterilized; Better than 20/80 ETDRS best corrected visual acuity; Mild to moderate nonexudative AMD (AMD steps 3 through 8 on Age-Related Eye Disease Study (AREDS) Report No. 17 grading scale); Willing to sign informed consent, comply with study protocol requirements, and undergo up to 2.5 hours of testing at each visit; Exclusion Criteria: Past or current exudative AMD or any geographic atrophy (on fundus autofluorescence) in study eye; Past or current other retinal or choroidal vasculopathy in study eye (e.g. pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous retinopathy, retinal vein occlusion, sickle cell retinopathy); Uncontrolled hypertension (≥ 150 systolic or ≥95 diastolic); Diabetes mellitus; Glaucoma; Lens opacity ≥ grade 3 ARLNS on standard photographs; Unable to complete biophysical testing; Unable to give informed consent; 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 GI surgery (e.g. bariatric surgery); Unwilling or unable to take an AREDS formula vitamin (without beta-carotene/vitamin A); Current or past use of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazimine, cisplatin, carmustine (BCNU), or deferoxamine; Tobacco smoking (currently or within past 5 years); 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 of enrollment; Currently being treated for cancer or any disease likely to adversely affect participation in a 2 year study; Known to have AIDS/HIV

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MC-1101 1% Ophthalmic Solution<br> | Drug: MC-1101<br>* 1% Ophthalmic Solution TID<br>|
| Placebo Comparator: Vehicle control<br> | Drug: MC-1101 Vehicle<br>* Ophthalmic solution, TID<br>|

What is the study measuring?
-----------------
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. | 12 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-1101 compared to vehicle control at each study visit following treatment for 2 years | 24 months | 

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