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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014