Back to resultsA Pilot Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Dry AMD
Primary Purpose
Age-Related Macular Degeneration
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MC-1101
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of dry AMD or;
- Normal, healthy volunteer
Exclusion Criteria:
- Uncontrolled systemic disease
- Women who are pregnant, nursing, or planning a pregnancy during the study's duration
Sites / Locations
- Andover Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Vehicle
Arm Description
Topical administration of MC-1101
Vehicle
Outcomes
Primary Outcome Measures
Ocular safety
Secondary Outcome Measures
Choroidal blood flow assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01013376
Brief Title
A Pilot Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Dry AMD
Official Title
A Pilot, Single-Center, Open-Label Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Non-exudative Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MacuCLEAR, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The safety and comfort of repeated administrations of a topically-administered ophthalmic formulation of MC-1101 will be established through investigator assessments and subject reporting over a 3 day period. Safety assessments will be performed on both normal, healthy subjects as well as those with the signs and symptoms of early non-exudative age-related macular degeneration (dry AMD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Topical administration of MC-1101
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
MC-1101
Intervention Description
MC-1101 1.0%
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle
Primary Outcome Measure Information:
Title
Ocular safety
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Choroidal blood flow assessment
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of dry AMD or;
Normal, healthy volunteer
Exclusion Criteria:
Uncontrolled systemic disease
Women who are pregnant, nursing, or planning a pregnancy during the study's duration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail L Torkildsen, M.D.
Organizational Affiliation
Andover Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Dry AMD
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