A Pilot Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Dry AMD
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
1 other identifier
interventional
31
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 12, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedNovember 13, 2009
November 1, 2009
Same day
November 12, 2009
November 12, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Ocular safety
3 days
Secondary Outcomes (1)
Choroidal blood flow assessment
3 days
Study Arms (2)
Active
EXPERIMENTALTopical administration of MC-1101
Vehicle
PLACEBO COMPARATORVehicle
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of dry AMD or;
- Normal, healthy volunteer
You may not qualify if:
- Uncontrolled systemic disease
- Women who are pregnant, nursing, or planning a pregnancy during the study's duration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MacuCLEAR, Inc.lead
Study Sites (1)
Andover Eye Associates
Andover, Massachusetts, 01810, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail L Torkildsen, M.D.
Andover Eye Associates
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 12, 2009
First Posted
November 13, 2009
Study Start
August 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
November 13, 2009
Record last verified: 2009-11