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Faricimab is supplied in a single use vial.",[13],"Drug: Faricimab",{"label":15,"type":10,"description":16,"interventionNames":17},"Fluocinolone Acetonide Intravitreal Implants","Study eyes assigned to receive fluocinolone acetonide intravitreal implant will receive a dose of 0.19 mg fluocinolone acetonide intravitreal implant (Iluvien). The implant is supplied in a sterile single use applicator with a 25-gauge needle",[18],"Drug: fluocinolone acetonide",{"label":20,"type":21,"description":22,"interventionNames":22},"Observation","NO_INTERVENTION",null,[24,29],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":22},"DRUG","Faricimab","6.0 mg intravitreal injection at randomization and every 3 months",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":22},"fluocinolone acetonide","0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months",[15],[34],{"name":35,"role":36,"phone":37,"phoneExt":22,"email":38},"Cynthia Stockdale, MPH","CONTACT","8139758690","DRCRNET@JAEB.ORG",[40,59,74,89,104,119,130,145,160,176,190,205,220,230,245,260,274,288,303,318,332,347,361,375],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Byers Eye Institute at Stanford University","RECRUITING","Palo Alto","California","94303","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-122.14302,37.44188,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":57,"phoneExt":22,"email":58},"Prithvi Mruthyunjaya, MD, MHS","6504988790","moniquenguyen92@stanford.edu",{"facility":60,"status":42,"city":61,"state":62,"zip":63,"country":46,"countryCode":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Retina Consultants","Manchester","Connecticut","06042",{"type":49,"coordinates":65},[66,67],-72.52148,41.77593,{"lat":67,"lon":66},[70],{"name":71,"role":36,"phone":72,"phoneExt":22,"email":73},"Noam Rudnick, MD, PhD","2036458430","cdwy@retinact.com",{"facility":75,"status":42,"city":76,"state":77,"zip":78,"country":46,"countryCode":47,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Retina Associates of Florida, LLC","Tampa","Florida","33609",{"type":49,"coordinates":80},[81,82],-82.45843,27.94752,{"lat":82,"lon":81},[85],{"name":86,"role":36,"phone":87,"phoneExt":22,"email":88},"Ivan J. 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Binkley, MD","3193563185","mary-m-mccormick@uiowa.edu",{"facility":161,"status":42,"city":162,"state":163,"zip":164,"country":46,"countryCode":47,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Foundation for Vision Research and Retina Specialists of Michigan, P.C.","Grand Rapids","Michigan","49546",{"type":49,"coordinates":166},[167,168],-85.66809,42.96336,{"lat":168,"lon":167},[171,174],{"name":172,"role":36,"phone":22,"phoneExt":22,"email":173},"Thomas M. Aaberg, Jr, MD","holly@fvr.org",{"name":22,"role":36,"phone":175,"phoneExt":22,"email":22},"616-954-2020",{"facility":177,"status":42,"city":178,"state":163,"zip":179,"country":46,"countryCode":47,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Associated Retinal Consultants, P.C.","Royal Oak","48073",{"type":49,"coordinates":181},[182,183],-83.14465,42.48948,{"lat":183,"lon":182},[186],{"name":187,"role":36,"phone":188,"phoneExt":22,"email":189},"Adam Weiner","2482889132","dgedvilas@arcpc.net",{"facility":191,"status":42,"city":192,"state":193,"zip":194,"country":46,"countryCode":47,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Mayo Clinic","Rochester","Minnesota","55905",{"type":49,"coordinates":196},[197,198],-92.4699,44.02163,{"lat":198,"lon":197},[201],{"name":202,"role":36,"phone":203,"phoneExt":22,"email":204},"Lauren Dalvin, MD","507-538-8119","wernimont.suzanne@mayo.edu",{"facility":206,"status":42,"city":207,"state":208,"zip":209,"country":46,"countryCode":47,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Retina Research Institute, LLC","St Louis","Missouri","63128",{"type":49,"coordinates":211},[212,213],-90.19789,38.62727,{"lat":213,"lon":212},[216],{"name":217,"role":36,"phone":218,"phoneExt":22,"email":219},"Bradley T. 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Lally, MD","2159283124","lisac@shields.md",{"facility":275,"status":42,"city":276,"state":248,"zip":277,"country":46,"countryCode":47,"cosmosGeoPoint":278,"geoPoint":282,"contacts":283},"Pittsburgh Clinical Trial Consortium","Sewickley","15143",{"type":49,"coordinates":279},[280,281],-80.1845,40.53646,{"lat":281,"lon":280},[284],{"name":285,"role":36,"phone":286,"phoneExt":22,"email":287},"Pamela P. Rath","4123015326","franco@pghtrials.com",{"facility":289,"status":42,"city":290,"state":291,"zip":292,"country":46,"countryCode":47,"cosmosGeoPoint":293,"geoPoint":297,"contacts":298},"Retina Consultants of Carolina, PA","Greenville","South Carolina","29605",{"type":49,"coordinates":294},[295,296],-82.39401,34.85262,{"lat":296,"lon":295},[299],{"name":300,"role":36,"phone":301,"phoneExt":22,"email":302},"Chris S. Bergstrom, MD","864-233-5722","Lfrazier@retina-consultants.com",{"facility":304,"status":42,"city":305,"state":306,"zip":307,"country":46,"countryCode":47,"cosmosGeoPoint":308,"geoPoint":312,"contacts":313},"Southeastern Retina Associates","Hixson","Tennessee","37343",{"type":49,"coordinates":309},[310,311],-85.23273,35.14063,{"lat":311,"lon":310},[314],{"name":315,"role":36,"phone":316,"phoneExt":22,"email":317},"Asghar A. Haider","423-756-1002","kschratter@seretina.com",{"facility":319,"status":42,"city":320,"state":306,"zip":321,"country":46,"countryCode":47,"cosmosGeoPoint":322,"geoPoint":326,"contacts":327},"Tennessee Retina, PC","Nashville","37203",{"type":49,"coordinates":323},[324,325],-86.78444,36.16589,{"lat":325,"lon":324},[328],{"name":329,"role":36,"phone":330,"phoneExt":22,"email":331},"David A. Reichstein, MD","6159836000","apecora@tnretina.com",{"facility":333,"status":42,"city":334,"state":335,"zip":336,"country":46,"countryCode":47,"cosmosGeoPoint":337,"geoPoint":341,"contacts":342},"Retina Consultants of Texas, PA","Bellaire","Texas","77401",{"type":49,"coordinates":338},[339,340],-95.45883,29.70579,{"lat":340,"lon":339},[343],{"name":344,"role":36,"phone":345,"phoneExt":22,"email":346},"Amy C Schefler, MD","713-524-3434","allison.stroh@retinaconsultantstexas.com",{"facility":348,"status":42,"city":349,"state":335,"zip":350,"country":46,"countryCode":47,"cosmosGeoPoint":351,"geoPoint":355,"contacts":356},"UT Southwestern Medical Center","Dallas","75390",{"type":49,"coordinates":352},[353,354],-96.80667,32.78306,{"lat":354,"lon":353},[357],{"name":358,"role":36,"phone":359,"phoneExt":22,"email":360},"Noy Ashkenazy, MD","214-645-2012","norma.ortegon@utsouthwestern.edu",{"facility":362,"status":42,"city":363,"state":335,"zip":364,"country":46,"countryCode":47,"cosmosGeoPoint":365,"geoPoint":369,"contacts":370},"Texas Retina Associates","Lubbock","79424",{"type":49,"coordinates":366},[367,368],-101.85517,33.57786,{"lat":368,"lon":367},[371],{"name":372,"role":36,"phone":373,"phoneExt":22,"email":374},"Michel Shami, MD","806-792-0066","lbrannan@texasretina.com",{"facility":376,"status":42,"city":377,"state":378,"zip":379,"country":46,"countryCode":47,"cosmosGeoPoint":380,"geoPoint":384,"contacts":385},"The Board of Regents of the University of Wisconsin System","Madison","Wisconsin","53705",{"type":49,"coordinates":381},[382,383],-89.40123,43.07305,{"lat":383,"lon":382},[386],{"name":387,"role":36,"phone":388,"phoneExt":22,"email":389},"Michael M. Altaweel, MD","608-263-7290","kadietzman@wisc.edu",{"type":391,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[393,396,398,401],{"name":394,"class":395},"National Eye Institute (NEI)","NIH",{"name":397,"class":395},"National Institutes of Health (NIH)",{"name":399,"class":400},"Alimera Sciences","INDUSTRY",{"name":402,"class":400},"Genentech, Inc.","100504184","phase-3-intravitreal-faricimab-injections-or-fluocinolone-acetonide-019-mg-intravitreal-implants-vs-observation-for-prevention-of-va-loss-due-to-radiation-retinopathy-100504184",false,"NCT05844982","Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy","A Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss Due to Radiation Retinopathy","AL","Key Inclusion Criteria\n\n* Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy\n* Absence of unrelated cause of visual loss\n* Baseline visual acuity ≥ 34 letters (20\u002F200 Snellen equivalent or better)\n* Posterior tumor margin \\>0 mm from the center of the macula (i.e., tumor is NOT under the geometric center of the fovea)\n* Posterior tumor margin \\>0 mm from the closest disc margin (i.e., tumor is not touching the edge of the optic disc)\n* Calculated total dose to center of the macula ≥30 Gy\n\nKey Exclusion Criteria\n\n* Opaque media\n* Inability to undergo fluorescein angiography\n* Less than 18 years of age\n* Prior vitrectomy\n* Intraocular pressure (IOP) ≥ 25 mmHg or history of steroid- induced IOP elevation that required treatment at baseline\n* IOP ≥ 25 mmHg at randomization or increase in IOP ≥ 8 mmHg from baseline to randomization (following steroid challenge","ALL","18 Years",{"count":414,"type":415},600,"ESTIMATED","INTERVENTIONAL",[418],"PHASE3","This randomized controlled trial will evaluate the effect of intravitreal faricimab or fluocinolone acetonide (FAc) intravitreal implant compared with observation on long-term visual acuity following treatment of choroidal melanoma with iodine-125 plaque brachytherapy.",[421,422],"Radiation Retinopathy","Visual Impairment",[424,425,426,427],"Visual Acuity","Radiation retinopathy","Faricima","Fluocinolone Acetonide","2026-06-12",{"date":430,"type":431},"2026-06-15","ACTUAL",{"date":433,"type":431},"2023-11-21",{"date":435,"type":415},"2029-12-26",{"name":5,"class":6},24]