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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 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: June 19, 2015
Last verified: June 2015
  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: July 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Paul Yates, MD, PhD 804-513-9119 klh7v@virginia.edu

  Show 29 Study Locations
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, Associate 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: June 19, 2015
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:
Atrophy
Geographic Atrophy
Macular Degeneration
Eye Diseases
Pathological Conditions, Anatomical
Retinal Degeneration
Retinal Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on June 30, 2015