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

NCT02127463 | Unknown Phase 2 DMC

• 1 other identifier: MC-1101-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Exudative Age Related Macular Degeneration

Keywords

AMD; Dry AMD; Non-Exudative AMD; MC-1101

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Up to 24 months

Study Arms (2)

MC-1101 active

EXPERIMENTAL

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

Drug: MC-1101

MC-1101 Vehicle Control

PLACEBO COMPARATOR

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

Drug: MC-1101 Vehicle

Interventions

MC-1101 DRUG

Topically, two times a day, morning and bedtime

Also known as: 1% Ophthalmic Solution

MC-1101 active

MC-1101 Vehicle DRUG

Topically, two times a day; morning and bedtime

Also known as: Topical Ophthalmic Solution

MC-1101 Vehicle Control

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females age ≥ 50 years and ≤ 85 years
• Females only: At least 1year since last menstrual period or surgically sterilized
• /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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MacuCLEAR, Inc.: lead

Study Sites (1)

Rocky Mountain Retina Consultants

Murray, Utah, 84107, United States

RECRUITING

MeSH Terms

Interventions

Ophthalmic Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Mitchell J Goff, MD

  Rocky Mountain Retina Consultants

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip G Ralston, MBA

CONTACT

2145775999; pralston@macuclear.com

Mitchell J Goff, MD

CONTACT

8012644444; mmmgoff@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: April 30, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

US (1)