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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01782989

Acronym

TOGA

Enrollment

286

Registered

2013-02-04

Start date

2013-02-28

Completion date

2020-11-30

Last updated

2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geographic Atrophy

Keywords

geographic atrophy, non-exudative age-related macular degeneration, macular degeneration, dry macular degeneration, dry AMD

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.

Interventions

DRUGPlacebo

Placebo capsule daily for 24 months

DRUGORACEA®

ORACEA® (40mg doxycycline) capsule daily for 24 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change in Best Corrected Visual Acuity (BCVA)	Month 6 and Month 30

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026