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

NCT ID: NCT01013376

Last Updated: 2009-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-08-31

Brief Summary

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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

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Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active

Topical administration of MC-1101

Group Type EXPERIMENTAL

MC-1101

Intervention Type DRUG

MC-1101 1.0%

Vehicle

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Vehicle

Interventions

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MC-1101

MC-1101 1.0%

Intervention Type DRUG

Vehicle

Vehicle

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MacuCLEAR, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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MacuCLEAR, Inc.

Principal Investigators

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Gail L Torkildsen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Andover Eye Associates

Locations

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Andover Eye Associates

Andover, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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MC1101-CBF-01

Identifier Type: -

Identifier Source: org_study_id

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