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A Pilot Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Dry AMD

This study has been completed.
Sponsor:
Information provided by:
MacuCLEAR, Inc.
ClinicalTrials.gov Identifier:
NCT01013376
First received: November 12, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 Intervention Phase
Age-Related Macular Degeneration
 Drug: MC-1101
Drug: Vehicle
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MacuCLEAR, Inc.:

Primary Outcome Measures:
  • Ocular safety [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Choroidal blood flow assessment [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: August 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Topical administration of MC-1101
 Drug: MC-1101
MC-1101 1.0%
Placebo Comparator: Vehicle
Vehicle
 Drug: Vehicle
Vehicle

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013376

Locations
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
MacuCLEAR, Inc.
Investigators
Principal Investigator: Gail L Torkildsen, M.D. Andover Eye Associates
  More Information

No publications provided

Responsible Party: Philip G. Ralston, Jr. / President & CEO, MacuCLEAR, Inc.
ClinicalTrials.gov Identifier: NCT01013376     History of Changes
Other Study ID Numbers: MC1101-CBF-01
Study First Received: November 12, 2009
Last Updated: November 12, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013