drugset / Trial / NCT01601483

Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration

NCT01601483

Phase 2/3 Terminated 22 enrolled MacuCLEAR, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase II/III vehicle controlled, double masked, single center study. A single eye of 60 individuals with mild to moderate nonexudative 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 12, 18 and 24 months.

Timeline

Start
2012-10
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydralazine Small molecule 1 % Topical