Trial | NCT01013376  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    hydralazine ...

  • Study Participants

    31
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).
Study Started
Aug 31
2009
Primary Completion
Aug 31
2009
Study Completion
Aug 31
2009
Last Update
Nov 13
2009
Estimate

Drug MC-1101

MC-1101 1.0%

Drug Vehicle

Vehicle

Active Experimental

Topical administration of MC-1101

Vehicle Placebo Comparator

Vehicle

Criteria 

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
No Results Posted