Geographic AtrophyPhase 2/3TOGANCT01782989
Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)
A Phase 2/3 study testing ORACEA® in people with Geographic Atrophy, run by Paul Yates, MD, PhD at 37 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Geographic Atrophy
- What is being tested?
- ORACEA®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 37 sitesUnited States
- Study dates
- Feb 2013to Nov 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Brian B. Berger, MD and Associates / Retina Research Center
Austin, Texas, 78705
Gailey Eye Clinic
Bloomington, Illinois, 61704
New England Eye Center at Tufts Medical Center
Boston, Massachusetts, 02111
Harvard Vanguard Medical Associates
Boston, Massachusetts, 02215
Pennsylvania Retina Specialists, PC
Camp Hill, Pennsylvania, 17011
Retina Cosultants
Charleston, West Virginia, 25301
University of Virginia
Charlottesville, Virginia, 22903
Lifelong Vision Foundation
Chesterfield, Missouri, 63017
Cole Eye Institute / Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Oregon Retina
Eugene, Oregon, 97401
Retina Group of Florida
Fort Lauderdale, Florida, 33308
Macula and Retina Institute
Glendale, California, 91203
Colorado Retina Associates, PC
Golden, Colorado, 80401
Retina Specialists of Michigan
Grand Rapids, Michigan, 49525
New England Retina Associates
Hamden, Connecticut, 06518
Delaware Valley Retina Associates
Lawrenceville, New Jersey, 08648
Retina Associates of Kentucky
Lexington, Kentucky, 40509
Eldorado Retina Associates
Louisville, Colorado, 80027
Retina Center
Minneapolis, Minnesota, 55404
MaculaCare
New York, New York, 10021
Vitreous Retina Macula Consultants of New York
New York, New York, 10022
New York Eye and Ear
New York, New York
Retinal and Ophthalmic Consultants
Northfield, New Jersey, 08225
Medical Center Eye Institute / Gulf Region Clinical Research Institute
Pensacola, Florida, 32514
Mid Atlantic Retina / Wills Eye Institute
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Eye Center
Pittsburgh, Pennsylvania, 15213
Retina Consultants of San Diego
Poway, California, 92064
Retina Associates of Western New York
Rochester, New York, 14620
Retina Associates of South Texas
San Antonio, Texas, 78240
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33703
New Jersey Retina
Toms River, New Jersey, 08755
Wagner Macula & Retina Center
Virginia Beach, Virginia, 23462
Virginia Retina Center
Warrenton, Virginia, 20186
George Washington University
Washington D.C., District of Columbia, 20037
Associates in Ophthalmology, Ltd
West Mifflin, Pennsylvania, 15122
Vitreo-Retinal Associates
Worcester, Massachusetts, 01605
About this study
Official title: 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).
Read the 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.
- Conditions
- Geographic Atrophy
- Being tested
- ORACEA®, Placebo
- Keywords
- geographic atrophy, non-exudative age-related macular degeneration, macular degeneration, dry macular degeneration, dry AMD
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORACEA®Drug
ORACEA® (40mg doxycycline) capsule daily for 24 months
PlaceboDrug
Placebo capsule daily for 24 months
| Study group | Role | What they receive |
|---|---|---|
| ORACEA® | Experimental | 40mg doxycycline Receives: Drug: ORACEA® |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of enlargement in area of geographic atrophy in the study eye during the treatment period.
Measured: Month 6 and Month 30
Secondary outcomes (1)
Change in Best Corrected Visual Acuity (BCVA)
Measured: Month 6 and Month 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Yates, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- MEDARVA Foundation
- Responsible party
- Sponsor-investigator, Paul Yates, MD, PhD, University of Virginia
- Investigators
- Paul A Yates, MD, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782989
- Sponsor's protocol ID
- 16586
- Acronym
- TOGA
- Status last verified
- Nov 2022
- First submitted
- 31 Jan 2013
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dalvi S, Roll M, Chatterjee A, Kumar LK, Bhogavalli A, Foley N, Arduino C, Spencer W, Reuben-Thomas C, Ortolan D, Pebay A, Bharti K, Anand-Apte B, Singh R. Human iPSC-based disease modeling studies identify a common mechanistic defect and potential therapies for AMD and related macular dystrophies. Dev Cell. 2024 Dec 16;59(24):3290-3305.e9. doi: 10.1016/j.devcel.2024.09.006. Epub 2024 Oct 2.
PubMed 39362220
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Study Evaluating ORACEA® in Subjects With Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01782989
- Acronym / sponsor ID
- TOGA / 16586
- Conditions
- Geographic Atrophy
- Keywords
- geographic atrophy, non-exudative age-related macular degeneration, macular degeneration, dry macular degeneration, dry AMD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Paul Yates, MD, PhDUniversity, hospital or other
- Collaborators
- MEDARVA Foundation
- Study start
- Feb 2013
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORACEA® | Experimental | Drug: ORACEA®40mg doxycycline |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORACEA®ORACEA® (40mg doxycycline) capsule daily for 24 months | Drug | ORACEA® |
| PlaceboPlacebo capsule daily for 24 months | Drug | Placebo |
Primary outcome
Rate of enlargement in area of geographic atrophy in the study eye during the treatment period.
Time frame: Month 6 and Month 30
1 secondary outcome
Change in Best Corrected Visual Acuity (BCVA)
Time frame: Month 6 and Month 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Derived from this study: PubMed 39362220Dalvi S, Roll M, Chatterjee A, Kumar LK, Bhogavalli A, Foley N, Arduino C, Spencer W, Reuben-Thomas C, Ortolan D, Pebay A, Bharti K, Anand-Apte B, Singh R. Human iPSC-based disease modeling studies identify a common mechanistic defect and potential therapies for AMD and related macular dystrophies. Dev Cell. 2024 Dec 16;59(24):3290-3305.e9. doi: 10.1016/j.devcel.2024.09.006. Epub 2024 Oct 2.
Related trials for Geographic Atrophy
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Yates, MD, PhD principal investigator
University of Virginia
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ORACEA® in people with Geographic Atrophy, run by Paul Yates, MD, PhD at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01782989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.