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

Primary Purpose

Non-Exudative Age Related Macular Degeneration

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MC-1101
MC-1101 Vehicle
Sponsored by
MacuCLEAR, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Exudative Age Related Macular Degeneration focused on measuring AMD, Dry AMD, Non-Exudative AMD, MC-1101

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rocky Mountain Retina ConsultantsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MC-1101 active

MC-1101 Vehicle Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 25, 2014
Last Updated
April 29, 2014
Sponsor
MacuCLEAR, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02127463
Brief Title
Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 in Treating DryAge-Related Macular Degeneration
Acronym
McCP2/3
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacuCLEAR, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Exudative Age Related Macular Degeneration
Keywords
AMD, Dry AMD, Non-Exudative AMD, MC-1101

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MC-1101 active
Arm Type
Experimental
Arm Description
Topical Drug 1% Ophthalmic Solution Topically, two times per day; morning and bedtime
Arm Title
MC-1101 Vehicle Control
Arm Type
Placebo Comparator
Arm Description
Topical Drug: Ophthalmic Solution Topically, two times per day; morning and bedtime
Intervention Type
Drug
Intervention Name(s)
MC-1101
Other Intervention Name(s)
1% Ophthalmic Solution
Intervention Description
Topically, two times a day, morning and bedtime
Intervention Type
Drug
Intervention Name(s)
MC-1101 Vehicle
Other Intervention Name(s)
Topical Ophthalmic Solution
Intervention Description
Topically, two times a day; morning and bedtime
Primary Outcome Measure Information:
Title
Visual Function
Description
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 Outcome Measure Information:
Title
Safety and tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip G Ralston, MBA
Phone
2145775999
Email
pralston@macuclear.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mitchell J Goff, MD
Phone
8012644444
Email
mmmgoff@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell J Goff, MD
Organizational Affiliation
Rocky Mountain Retina Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Retina Consultants
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kari Rasmussen, BS
Phone
801-264-4444
Email
kmrasmussen@yahoo.com
First Name & Middle Initial & Last Name & Degree
Katie Roach, RN
Phone
8012644444
Email
katie.roach@rockymountainretina.com
First Name & Middle Initial & Last Name & Degree
Mitchell J Goff, MD

12. IPD Sharing Statement

Learn more about this trial

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

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