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
  Purpose

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).


Condition Intervention Phase
Geographic Atrophy
Drug: ORACEA®
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled Study Evaluating ORACEA® in Subjects With Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Change in Best Corrected Visual Acuity (BCVA) [ Time Frame: Month 6 and Month 30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 286
Study Start Date: February 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ORACEA®
40mg doxycycline
Drug: ORACEA®
ORACEA® (40mg doxycycline) capsule daily for 24 months
Placebo Comparator: Placebo Drug: Placebo
Placebo capsule daily for 24 months

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782989

Contacts
Contact: Paul Yates, MD, PhD 434-243-2852 klh7v@virginia.edu

Locations
United States, Virginia
University of Virginia Not yet recruiting
Charlottesville, Virginia, United States, 22903
Contact: Kristina Holbrook    434-243-2852    klh7v@virginia.edu   
Principal Investigator: Paul Yates, MD, PhD         
Sponsors and Collaborators
Paul Yates, MD, PhD
MEDARVA Foundation
Investigators
Principal Investigator: Paul A Yates, MD, PhD University of Virginia
  More Information

No publications provided

Responsible Party: Paul Yates, MD, PhD, Assistant Professor of Ophthalmology, University of Virginia
ClinicalTrials.gov Identifier: NCT01782989     History of Changes
Other Study ID Numbers: 16586
Study First Received: January 31, 2013
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
geographic atrophy
non-exudative age-related macular degeneration
macular degeneration
dry macular degeneration
dry AMD

Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 16, 2014