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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:
ClinicalTrials.gov Identifier:
NCT01013376
First Posted: November 13, 2009
Last Update Posted: November 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
MacuCLEAR, Inc.
  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
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

Resource links provided by NLM:


Further study details as provided by MacuCLEAR, Inc.:

Primary Outcome Measures:
  • Ocular safety [ Time Frame: 3 days ]

Secondary Outcome Measures:
  • Choroidal blood flow assessment [ Time Frame: 3 days ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Philip G. Ralston, Jr. / President & CEO, MacuCLEAR, Inc.
ClinicalTrials.gov Identifier: NCT01013376     History of Changes
Other Study ID Numbers: MC1101-CBF-01
First Submitted: November 12, 2009
First Posted: November 13, 2009
Last Update Posted: November 13, 2009
Last Verified: November 2009

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