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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Geographic Atrophy

Intervention / Treatment
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* Drug: ORACEA®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ORACEA®<br>40mg doxycycline | Drug: ORACEA®<br>* ORACEA® (40mg doxycycline) capsule daily for 24 months<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo capsule daily for 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of enlargement in area of geographic atrophy in the study eye during the treatment period. |  | Month 6 and Month 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Best Corrected Visual Acuity (BCVA) |  | Month 6 and Month 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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geographic atrophy, non-exudative age-related macular degeneration, macular degeneration, dry macular degeneration, dry AMD