Clinical trial NCT02127463: Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 in Treating DryAge-Related Macular Degeneration
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Non-Exudative Age Related Macular Degeneration
Keywords: AMD
Dry AMD
Non-Exudative AMD
MC-1101
Lead sponsor: MacuCLEAR, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Function
timeFrame: Up to 24 months
Secondary outcomes:
measure: Safety and tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Murray
country: United States
facility: Rocky Mountain Retina Consultants
state: Utah
Study officials:
affiliation: Rocky Mountain Retina Consultants
name: Mitchell J Goff, MD
role: PRINCIPAL_INVESTIGATOR
References: