We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01013376
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : November 13, 2009
Information provided by:
MacuCLEAR, Inc.

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

Study Type : Interventional  (Clinical Trial)
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 : August 2009
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active
Topical administration of MC-1101
Drug: MC-1101
MC-1101 1.0%
Placebo Comparator: Vehicle
Drug: Vehicle

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

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

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

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

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

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

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 Posted: November 13, 2009    Key Record Dates
Last Update Posted: November 13, 2009
Last Verified: November 2009

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