A Pilot Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Dry AMD
Sponsor
MacuCLEAR, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01013376
Collaborator
(none)
31
1
2
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
31 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Aug 1, 2009
Actual Primary Completion Date
:
Aug 1, 2009
Actual Study Completion Date
:
Aug 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active Topical administration of MC-1101 |
Drug: MC-1101
MC-1101 1.0%
|
| Placebo Comparator: Vehicle Vehicle |
Drug: Vehicle
Vehicle
|
Outcome Measures
Primary Outcome Measures
- Ocular safety [3 days]
Secondary Outcome Measures
- Choroidal blood flow assessment [3 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Andover Eye Associates | Andover | Massachusetts | United States | 01810 |
Sponsors and Collaborators
- MacuCLEAR, Inc.
Investigators
- Principal Investigator: Gail L Torkildsen, M.D., Andover Eye Associates
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01013376
Other Study ID Numbers:
- MC1101-CBF-01
First Posted:
Nov 13, 2009
Last Update Posted:
Nov 13, 2009
Last Verified:
Nov 1, 2009
Additional relevant MeSH terms: