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

Tracking Information

First Received Date ^ICMJE

November 12, 2009

Last Updated Date

November 12, 2009

Start Date ^ICMJE

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Ocular safety [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Age-Related Macular Degeneration

Intervention ^ICMJE

Drug: MC-1101
MC-1101 1.0%
Drug: Vehicle
Vehicle

Study Arm (s)

Experimental: Active
Topical administration of MC-1101

Intervention: Drug: MC-1101
Placebo Comparator: Vehicle
Vehicle

Intervention: Drug: Vehicle

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01013376

Other Study ID Numbers ^ICMJE

MC1101-CBF-01

Has Data Monitoring Committee

Responsible Party

Philip G. Ralston, Jr. / President & CEO, MacuCLEAR, Inc.

Study Sponsor ^ICMJE

MacuCLEAR, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gail L Torkildsen, M.D.

Andover Eye Associates

Information Provided By

MacuCLEAR, Inc.

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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