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

Phase 1

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: MC-1101; Drug: Vehicle

• Registration Number: NCT01013376
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2009-11
• Study First Submitted: 2009-11-12
• Study First Submitted QC: 2009-11-12
• Last Update Submitted: 2009-11-12
• Study First Posted: 2009-11-13
• Last Update Posted: 2009-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	MC-1101	Topical administration of MC-1101
Vehicle	Vehicle	Vehicle

Primary Outcome Measures

Name	Time	Method
Ocular safety	3 days

Secondary Outcome Measures

Name	Time	Method
Choroidal blood flow assessment	3 days

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States