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

M

MacuCLEAR

Status and phase

Completed
Phase 1

Conditions

Age-Related Macular Degeneration

Treatments

Drug: Vehicle
Drug: MC-1101

Study type

Interventional

Funder types

Industry

Identifiers

NCT01013376
MC1101-CBF-01

Details and patient eligibility

About

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).

Enrollment

31 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

31 participants in 2 patient groups, including a placebo group

Active
Experimental group
Description:
Topical administration of MC-1101
Treatment:
Drug: MC-1101
Vehicle
Placebo Comparator group
Description:
Vehicle
Treatment:
Drug: Vehicle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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