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

• ClinicalTrials.gov Identifier: NCT01782989
• Recruitment Status: Completed
• First Posted: February 4, 2013
• Last Update Posted: November 4, 2022
• Sponsor: Paul Yates, MD, PhD
• Collaborator: MEDARVA Foundation
• Information provided by (Responsible Party): Paul Yates, MD, PhD, University of Virginia

Tracking Information

• First Submitted Date: January 31, 2013
• First Posted Date: February 4, 2013
• Last Update Posted Date: November 4, 2022
• Study Start Date: February 2013
• Actual Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 31, 2013): Rate of enlargement in area of geographic atrophy in the study eye during the treatment period. [ Time Frame: Month 6 and Month 30 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 31, 2013): Change in Best Corrected Visual Acuity (BCVA) [ Time Frame: Month 6 and Month 30 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)
• Official Title: A Randomized, Double Blind, Placebo Controlled Study Evaluating ORACEA® in Subjects With Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration
• Brief Summary: 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).
• 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.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Geographic Atrophy

Intervention

• Drug: ORACEA®
  ORACEA® (40mg doxycycline) capsule daily for 24 months
• Drug: Placebo
  Placebo capsule daily for 24 months

Study Arms

• Experimental: ORACEA®
  40mg doxycycline
  Intervention: Drug: ORACEA®
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 31, 2013): 286
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2020
• Actual Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01782989
• Other Study ID Numbers: 16586
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Paul Yates, MD, PhD, University of Virginia
• Original Responsible Party: Paul Yates, MD, University of Virginia, Assistant Professor of Ophthalmology
• Current Study Sponsor: Paul Yates, MD, PhD
• Original Study Sponsor: Paul Yates, MD
• Collaborators: MEDARVA Foundation

Investigators

• Principal Investigator: Paul A Yates, MD, PhD; University of Virginia

• PRS Account: University of Virginia
• Verification Date: November 2022