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| Name | Class |
|---|---|
| MEDARVA Foundation | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORACEA® | Experimental | 40mg doxycycline |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORACEA® | Drug | ORACEA® (40mg doxycycline) capsule daily for 24 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of enlargement in area of geographic atrophy in the study eye during the treatment period. | Month 6 and Month 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) | Month 6 and Month 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul A Yates, MD, PhD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macula and Retina Institute | Glendale | California | 91203 | United States | ||
| Retina Consultants of San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39362220 | Derived | 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. |
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| Placebo |
| Drug |
Placebo capsule daily for 24 months |
|
| Poway |
| California |
| 92064 |
| United States |
| Colorado Retina Associates, PC | Golden | Colorado | 80401 | United States |
| Eldorado Retina Associates | Louisville | Colorado | 80027 | United States |
| New England Retina Associates | Hamden | Connecticut | 06518 | United States |
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
| Retina Group of Florida | Fort Lauderdale | Florida | 33308 | United States |
| Medical Center Eye Institute / Gulf Region Clinical Research Institute | Pensacola | Florida | 32514 | United States |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33703 | United States |
| Gailey Eye Clinic | Bloomington | Illinois | 61704 | United States |
| Retina Associates of Kentucky | Lexington | Kentucky | 40509 | United States |
| New England Eye Center at Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Harvard Vanguard Medical Associates | Boston | Massachusetts | 02215 | United States |
| Vitreo-Retinal Associates | Worcester | Massachusetts | 01605 | United States |
| Retina Specialists of Michigan | Grand Rapids | Michigan | 49525 | United States |
| Retina Center | Minneapolis | Minnesota | 55404 | United States |
| Lifelong Vision Foundation | Chesterfield | Missouri | 63017 | United States |
| Delaware Valley Retina Associates | Lawrenceville | New Jersey | 08648 | United States |
| Retinal and Ophthalmic Consultants | Northfield | New Jersey | 08225 | United States |
| New Jersey Retina | Toms River | New Jersey | 08755 | United States |
| MaculaCare | New York | New York | 10021 | United States |
| Vitreous Retina Macula Consultants of New York | New York | New York | 10022 | United States |
| New York Eye and Ear | New York | New York | United States |
| Retina Associates of Western New York | Rochester | New York | 14620 | United States |
| Cole Eye Institute / Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oregon Retina | Eugene | Oregon | 97401 | United States |
| Pennsylvania Retina Specialists, PC | Camp Hill | Pennsylvania | 17011 | United States |
| Mid Atlantic Retina / Wills Eye Institute | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh Eye Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Associates in Ophthalmology, Ltd | West Mifflin | Pennsylvania | 15122 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Brian B. Berger, MD and Associates / Retina Research Center | Austin | Texas | 78705 | United States |
| Retina Associates of South Texas | San Antonio | Texas | 78240 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Wagner Macula & Retina Center | Virginia Beach | Virginia | 23462 | United States |
| Virginia Retina Center | Warrenton | Virginia | 20186 | United States |
| Retina Cosultants | Charleston | West Virginia | 25301 | United States |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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