Non-Exudative Age Related Macular Degeneration Clinical Trial
Official title:
Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 1.0% BID in the Treatment of Non-exudative Age-Related Macular Degeneration
This is a Phase II/III,vehicle controlled, double masked, single center study. A single eye
of 60 individuals with mild to moderate non-exudative Age-Related Macular Degeneration (AMD)
will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2
years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for
these patients.
An analysis of the primary and secondary endpoints will be conducted when all subjects have
completed Baseline, 1, 3, 6, 12,18 and 24 months.
MC-1101is a topically administered drug which in previous clinical studies has been proven to get to the back of the eye. MC-1101is a 505 (b) 2 compound and has FDA Fast Track Status. It is a strong, vasoactive drug which is intended to increase choroidal blood flow. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment