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Status unknownNCT02127463McCP2/3Updated Apr 30, 2014

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

A Phase 2/3 interventional study of MC-1101 and MC-1101 Vehicle in Non-Exudative Age Related Macular Degeneration, sponsored by MacuCLEAR, Inc.. Status unknown at 1 site in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-04-30.

Sponsored by MacuCLEAR, Inc. · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Non-Exudative Age Related Macular Degeneration

Keywords

  • AMD
  • Dry AMD
  • Non-Exudative AMD
  • MC-1101
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's planned enrollment of 60 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

MacuCLEAR, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    MC-1101 active

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

    Drug: MC-1101

  • Placebo comparator
    MC-1101 Vehicle Control

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

    Drug: MC-1101 Vehicle

Interventions

  • DrugMC-1101

    Topically, two times a day, morning and bedtime

    Also known as: 1% Ophthalmic Solution

  • DrugMC-1101 Vehicle

    Topically, two times a day; morning and bedtime

    Also known as: Topical Ophthalmic Solution

06

What researchers measure

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.

    Time frame: Up to 24 months

Secondary outcomes

  1. 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.

    Time frame: Up to 24 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02127463
Lead sponsor
MacuCLEAR, Inc.
Responsible party
Sponsor
First posted
Apr 30, 2014
Start date
Apr 2014
Primary completion
Apr 2016 (estimated)
Completion
Apr 2016 (estimated)
Last update
Apr 30, 2014

Study contacts

Philip G Ralston, MBA
Contact
pralston@macuclear.com
2145775999
Mitchell J Goff, MD
Contact
mmmgoff@yahoo.com
8012644444
Mitchell J Goff, MD
principal investigator · Rocky Mountain Retina Consultants

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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