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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
Sponsor:
Information provided by:
MacuCLEAR, Inc.

Study Description
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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 Design
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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
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


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

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

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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
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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
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United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
MacuCLEAR, Inc.
Investigators
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Principal Investigator: Gail L Torkildsen, M.D. Andover Eye Associates
More Information
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Responsible Party: Philip G. Ralston, Jr. / President & CEO, MacuCLEAR, Inc.
ClinicalTrials.gov Identifier: NCT01013376    
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:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases