McCP2/3: Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 in Treating DryAge-Related Macular Degeneration

Sponsor

MacuCLEAR, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02127463

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Non-Exudative Age Related Macular Degeneration	Drug: MC-1101 Drug: MC-1101 Vehicle	Phase 2/Phase 3

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2016

Anticipated Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MC-1101 active Topical Drug 1% Ophthalmic Solution Topically, two times per day; morning and bedtime	Drug: MC-1101 Topically, two times a day, morning and bedtime Other Names: 1% Ophthalmic Solution
Placebo Comparator: MC-1101 Vehicle Control Topical Drug: Ophthalmic Solution Topically, two times per day; morning and bedtime	Drug: MC-1101 Vehicle Topically, two times a day; morning and bedtime Other Names: Topical Ophthalmic Solution

Arm

Intervention/Treatment

Experimental: MC-1101 active

Topical Drug 1% Ophthalmic Solution Topically, two times per day; morning and bedtime

Drug: MC-1101

Topically, two times a day, morning and bedtime

Other Names:

1% Ophthalmic Solution

Placebo Comparator: MC-1101 Vehicle Control

Topical Drug: Ophthalmic Solution Topically, two times per day; morning and bedtime

Drug: MC-1101 Vehicle

Topically, two times a day; morning and bedtime

Other Names:

Topical Ophthalmic Solution

Outcome Measures

Primary Outcome Measures

Visual Function [Up to 24 months]
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.

Secondary Outcome Measures

Safety and tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia) [Up to 24 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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