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

P

Paul Yates, MD, PhD

Status and phase

Completed
Phase 3
Phase 2

Conditions

Geographic Atrophy

Treatments

Drug: Placebo
Drug: ORACEA®

Study type

Interventional

Funder types

Other

Identifiers

NCT01782989
16586

Details and patient eligibility

About

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).

Full 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.

Enrollment

286 patients

Sex

All

Ages

55+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

286 participants in 2 patient groups, including a placebo group

ORACEA®
Experimental group
Description:
40mg doxycycline
Treatment:
Drug: ORACEA®
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

37

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Data sourced from clinicaltrials.gov

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