Clinical Trial: Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Double Blind, Placebo Controlled Study Evaluating ORACEA® in Subjects With Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneratio

Brief Summary: This is a prospective, randomized study to evaluate the efficacy and safety of ORACEA® in the treatment of geographic atrophy due to dry age-related macular degeneration (AMD).

Detailed Summary: Eligible participants will complete a 6-month Observation Phase, followed by a 24-month Treatment Phase, followed by an End of Study Visit. Eligible participants will be randomized at Month 6 in a 1:1 ratio to either ORACEA (40 mg doxycycline) or placebo capsule to be taken once-daily for 24 months. Over the course of the 31-month study, a total of 9 clinic visits and 3 telephone calls are required.
Sponsor: Paul Yates, MD, PhD

Current Primary Outcome: Rate of enlargement in area of geographic atrophy in the study eye during the treatment period. [ Time Frame: Month 6 and Month 30 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in Best Corrected Visual Acuity (BCVA) [ Time Frame: Month 6 and Month 30 ]

Original Secondary Outcome: Same as current

Information By: University of Virginia

Dates:
Date Received: January 31, 2013
Date Started: February 2013
Date Completion: December 2018
Last Updated: May 6, 2016
Last Verified: May 2016