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

This study is not yet open for participant recruitment.
Verified February 2013 by University of Virginia
Sponsor:
Collaborator:
MEDARVA Foundation
Information provided by (Responsible Party):
Paul Yates, MD, PhD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01782989
First received: January 31, 2013
Last updated: February 6, 2013
Last verified: February 2013

January 31, 2013
February 6, 2013
February 2013
March 2017   (final data collection date for primary outcome measure)
Rate of enlargement in area of geographic atrophy in the study eye during the treatment period. [ Time Frame: Month 6 and Month 30 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01782989 on ClinicalTrials.gov Archive Site
Change in Best Corrected Visual Acuity (BCVA) [ Time Frame: Month 6 and Month 30 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Geographic Atrophy
  • Drug: ORACEA®
    ORACEA® (40mg doxycycline) capsule daily for 24 months
  • Drug: Placebo
    Placebo capsule daily for 24 months
  • Experimental: ORACEA®
    40mg doxycycline
    Intervention: Drug: ORACEA®
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
286
December 2017
March 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, age 55 - 85.
  • 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
Both
55 Years to 85 Years
No
Contact: Paul Yates, MD, PhD 434-243-2852 klh7v@virginia.edu
United States
 
NCT01782989
16586
Yes
Paul Yates, MD, PhD, University of Virginia
Paul Yates, MD, PhD
MEDARVA Foundation
Principal Investigator: Paul A Yates, MD, PhD University of Virginia
University of Virginia
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP