NCT01782989

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: Paul Yates, MD, PhD · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Geographic Atrophy

Interventions

Type	Name	Description
DRUG	ORACEA®	ORACEA® (40mg doxycycline) capsule daily for 24 months
DRUG	Placebo	Placebo capsule daily for 24 months

Timeline

• Start date: 2013-02-01
• Primary completion: 2020-11-01
• Completion: 2020-11-01
• First posted: 2013-02-04
• Last updated: 2022-11-04

Locations

37 sites across 1 country: United States