Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA) (TOGA)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| 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
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Geographic Atrophy | Drug: ORACEA® Drug: Placebo | Phase 2 Phase 3 |
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 (Clinical Trial) |
| Actual Enrollment : | 286 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | February 2013 |
| Actual Primary Completion Date : | November 2020 |
| Actual Study Completion Date : | November 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
| Arm | Intervention/treatment |
|---|---|
|
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 |
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 ]
Secondary Outcome Measures :
- Change in Best Corrected Visual Acuity (BCVA) [ Time Frame: Month 6 and Month 30 ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782989
Locations
Show 37 study locations
Sponsors and Collaborators
Paul Yates, MD, PhD
MEDARVA Foundation
Investigators
| Principal Investigator: | Paul A Yates, MD, PhD | University of Virginia |
| Responsible Party: | Paul Yates, MD, PhD, Associate Professor of Ophthalmology, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT01782989 |
| Other Study ID Numbers: |
16586 |
| First Posted: | February 4, 2013 Key Record Dates |
| Last Update Posted: | November 4, 2022 |
| Last Verified: | November 2022 |
Keywords provided by Paul Yates, MD, PhD, 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 Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |