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

Phase 2

Completed

• Conditions: Geographic Atrophy
• Interventions: Drug: ORACEA®; Drug: Placebo

• Registration Number: NCT01782989
• Lead Sponsor: Paul Yates, MD, PhD

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 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.

Study Timeline

• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-01-31
• Study Start: 2013-02
• Study First Posted: 2013-02-04
• Primary Completion: 2020-11
• Study Completion: 2020-11
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• Male or female, age >/=55 years
• Best corrected visual acuity of 20/20 - 20/400 in the study eye
• Best corrected visual acuity of hand motion or better in the non-study eye
• Clinical diagnosis of geographic atrophy secondary to non-exudative age-related macular degeneration in at least one eye (study eye)
• Geographic atrophy lesions of ≥ 0.5 and ≤ 7.0 MPS disc areas

Exclusion Criteria

• History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the study eye
• History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the non-study eye requiring any treatment within 12 months prior to Day 0 or expected to require treatment for the duration of the study
• Prior treatment for non-exudative age-related macular degeneration
• Current or previous history of treatment of the study eye with any tetracycline derivative for any ocular condition.
• History of vitreoretinal surgery, corneal transplant, or laser photocoagulation in the study eye
• Any intraocular or periocular surgery within 90 days prior to Day 0 in the study eye.
• History of any hypersensitivity to tetracycline components
• Use of a tetracycline derivative therapy for a concurrent systemic or ocular disorder within 90 days of Day 0
• History of sensitivity to the sun

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORACEA®	ORACEA®	40mg doxycycline
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Rate of enlargement in area of geographic atrophy in the study eye during the treatment period.	Month 6 and Month 30

Secondary Outcome Measures

Name	Time	Method
Change in Best Corrected Visual Acuity (BCVA)	Month 6 and Month 30

Trial Locations

Locations (37)

Macula and Retina Institute; 🇺🇸 Glendale, California, United States

Retina Consultants of San Diego; 🇺🇸 Poway, California, United States

Colorado Retina Associates, PC; 🇺🇸 Golden, Colorado, United States

Eldorado Retina Associates; 🇺🇸 Louisville, Colorado, United States

New England Retina Associates; 🇺🇸 Hamden, Connecticut, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

Retina Group of Florida; 🇺🇸 Fort Lauderdale, Florida, United States

Medical Center Eye Institute / Gulf Region Clinical Research Institute; 🇺🇸 Pensacola, Florida, United States

Retina Vitreous Associates of Florida; 🇺🇸 Saint Petersburg, Florida, United States

Gailey Eye Clinic; 🇺🇸 Bloomington, Illinois, United States

Scroll for more (27 remaining)