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This study will assess the safety in patients treated with ILUVIEN, with primary focus on IOP.
The specific objectives include the study of intraocular pressure (IOP) related data in patients who received ILUVIEN and how it relates to the patient's experiences following prior treatment with a course of corticosteroid which did not result in a clinically significant IOP elevation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ILUVIEN 0.19 MG | Experimental | All patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ILUVIEN 0.19 MG | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure | Intraocular pressure of the ILUVIEN treated eye | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Arizona | Phoenix | Arizona | 85014 | United States | ||
| Retina Centers, P.C. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38189802 | Derived | Eichenbaum D, Gonzalez VH, Roth D, Fortun J, Radcliffe NM, Cutino A, Kasper J, Coughlin BA, Arevalo JF. Ocular, Visual, and Anatomical Outcomes in Eyes Requiring Incisional Intraocular Pressure-Lowering Surgery Following the 0.19-mg Fluocinolone Acetonide Intravitreal Implant. Ophthalmic Surg Lasers Imaging Retina. 2024 Jan;55(1):22-23. doi: 10.3928/23258160-20231109-02. Epub 2024 Jan 1. | |
| 32461262 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 8, 2022 | |
| Reset | Jan 3, 2023 |
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| Tucson |
| Arizona |
| 85704 |
| United States |
| Retina and Macula Institute | Glendale | California | 91203 | United States |
| Atlantis Eye Care | Huntington Beach | California | 92647 | United States |
| Northern California Retina Vitreous Medical Group, Inc. | Mountain View | California | United States |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | United States |
| Eye Care Center of Northern Colorado | Longmont | Colorado | 80503 | United States |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | United States |
| Southeast Retina Center, P.C. | Augusta | Georgia | 30909 | United States |
| Retina Consultants of Hawaii | ‘Aiea | Hawaii | 96701 | United States |
| Chicagoland Eye and Retina Foundation | Chicago | Illinois | 60601 | United States |
| The University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| University Retina and Macula Associates | Oak Forest | Illinois | 63017 | United States |
| Illinois Retina Associates, SC | Oak Park | Illinois | 60304 | United States |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States |
| Sabates Eye Center Research Division | Leawood | Kansas | 66211 | United States |
| Paducah Retinal Center | Paducah | Kentucky | 42001 | United States |
| Eye Associates of Northeast Louisiana | West Monroe | Louisiana | 71291 | United States |
| University of Maryland Eye Associates | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Lifelong Vision Foundation | Chesterfield | Missouri | 63017 | United States |
| Discover Vision Centers | Independence | Missouri | 64055 | United States |
| Eyesight Ophthalmic Services, PA | Portsmouth | New Hampshire | 03801 | United States |
| New Jersey Retina | New Brunswick | New Jersey | 08901 | United States |
| Retina Associates of New Jersey | Teaneck | New Jersey | 07666 | United States |
| Joseph R. Podhorzer, MD PLLC | Brooklyn | New York | 11223 | United States |
| Ophthalmic Consultants of Long Island | Lynbrook | New York | 11563 | United States |
| Macula Care | New York | New York | 10021 | United States |
| Island Retina | Shirley | New York | United States |
| Tulsa Retina Consultants | Tulsa | Oklahoma | 74133 | United States |
| Laurel Eye Clinic | Brookville | Pennsylvania | United States |
| Pennsylvania Retina Specialist, PC | Camp Hill | Pennsylvania | 17011 | United States |
| Southeastern Retina Associates, PC | Kingsport | Tennessee | 37660 | United States |
| Retina Research Center | Austin | Texas | 78705 | United States |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | United States |
| Hampton Roads Retina Center | Chesapeake | Virginia | 23320 | United States |
| Virginia Retina Center | Warrenton | Virginia | 20186 | United States |
| Cascade Eye and Skin | University Place | Washington | 98467 | United States |
| Derived |
| Mansour SE, Kiernan DF, Roth DB, Eichenbaum D, Holekamp NM, Kaba S, Werts E. Two-year interim safety results of the 0.2 microg/day fluocinolone acetonide intravitreal implant for the treatment of diabetic macular oedema: the observational PALADIN study. Br J Ophthalmol. 2021 Mar;105(3):414-419. doi: 10.1136/bjophthalmol-2020-315984. Epub 2020 May 27. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 8, 2022 | Jan 3, 2023 |
| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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