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OpenTrials
Completed

NCT Number: NCT01013376

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

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).

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MC-1101

Drug

MC-1101 1.0%

Vehicle

Drug

Vehicle

Primary outcomes

  1. Ocular safety

    Time frame: 3 days

Secondary outcomes

  1. Choroidal blood flow assessment

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

MacuCLEAR, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 13, 2009
Registry last updated
Nov 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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