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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01013376

Enrollment

Registered

2009-11-13

Start date

2009-08-31

Completion date

2009-08-31

Last updated

2009-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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).

Interventions

DRUGMC-1101

MC-1101 1.0%

DRUGVehicle

Vehicle

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Ocular safety	3 days

Secondary

Measure	Time frame
Choroidal blood flow assessment	3 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026