Trial | NCT01782989  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    doxycycline ...

  • Study Participants

    286
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).
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 Started
Feb 28
2013
Primary Completion
Nov 30
2020
Study Completion
Nov 30
2020
Last Update
Nov 04
2022

Drug ORACEA®

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

Drug Placebo

Placebo capsule daily for 24 months

ORACEA® Experimental

40mg doxycycline

Placebo Placebo Comparator

Criteria 

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
No Results Posted