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Chithandizo Chatsopano cha Diabetes Retinopathy Chowonetsa Zotsatira Zabwino

Written by mkonzi

REGENXBIO Inc. yalengeza zina zowonjezera pakanthawi kochepa kuchokera ku mayeso omwe akuchitika a Phase II ALTITUDE™ a RGX-314 pochiza matenda a shuga a retinopathy (DR) popanda pakati-involved diabetic macular edema (CI-DME) pogwiritsa ntchito in-office suprachoroidal delivery. Deta ikuperekedwa ku msonkhano wa Angiogenesis, Exudation, and Degeneration 2022 ndi Michael A. Klufas, MD, Retina Service, Wills Eye Hospital, Pulofesa Wothandizira wa Ophthalmology, Thomas Jefferson University. RGX-314 ikufufuzidwa ngati chithandizo cha jini cha nthawi imodzi chochizira kunyowa kwa macular ndi DR.              

Kukonzekera kwa Phunziro ndi Kusintha kwa Chitetezo kuchokera ku Gawo II ALTITUDE Kuyesa kwa RGX-314 kwa Chithandizo cha DR Pogwiritsa Ntchito Suprachoroidal Delivery

ALTITUDE ndi mayeso apakati, otseguka, osasinthika, owongolera-kukwera kwa mlingo omwe amayesa mphamvu, chitetezo ndi kulekerera kwa suprachoroidal kutumiza kwa RGX-314 pogwiritsa ntchito SCS Microinjector® kwa odwala omwe ali ndi matenda a DR omwe ali ndi matenda a shuga amtundu wapakatikati kapena ovuta kwambiri. retinopathy (NPDR) kapena mild proliferative diabetesic retinopathy (PDR). Odwala makumi awiri mu Cohort 1 adasinthidwa mwachisawawa kuti alandire RGX-314 pa mlingo wa 2.5 × 1011 makope a genomic pa diso (GC / diso) motsutsana ndi kuyang'anitsitsa pa chiwerengero cha 3: 1. Gulu la 2 lidzaphatikizapo odwala a 20 osankhidwa mwachisawawa kuti alandire RGX-314 pa mlingo wowonjezereka wa 5 × 1011 GC / diso motsutsana ndi kuyang'anitsitsa pa chiwerengero cha 3: 1. Gulu la 3 lapangidwa kuti liwunikire RGX-314 pa mlingo wofanana ndi Cohort 2 mwa odwala 20 omwe akuletsa antibody (NAb) positive. Kulembetsa kukupitirirabe mu Cohorts 2 ndi 3. Odwala mu mayeserowa samalandira chithandizo cha prophylactic immune suppressive corticosteroid isanayambe kapena itatha kulamulira RGX-314.

Kuyambira pa Januwale 18, 2022, RGX-314 inanenedwa kuti inalekerera bwino mu Gulu la 1. Zochitika ziwiri zovuta kwambiri zinanenedwa mwa odwala awiri, onse omwe sanaganizidwe kuti ndi okhudzana ndi mankhwala osokoneza bongo. Mwa odwala a Cohort 1 omwe amamwa RGX-314, palibe kutupa kwa intraocular komwe kunawonedwa. Monga tanena kale, wodwala wina adakumana ndi vuto lochepa la episcleritis lomwe limathetsedwa ndi topical corticosteroids. Chithandizo chodziwika bwino chodziwika bwino chomwe chidachitika m'maso ophunzirira mpaka miyezi isanu ndi umodzi sichinali chokhudzana ndi mankhwala ndipo makamaka chinali chofatsa. Izi zikuphatikizapo conjunctival hemorrhage ndi conjunctival hyperemia.

Chidule cha Deta ya Gulu 1 pa Miyezi Sikisi

WTM London 2022 zidzachitika kuyambira 7-9 Novembala 2022. Lowetsani tsopano!

Pamiyezi isanu ndi umodzi, mwa odwala 15 omwe adamwa RGX-314 mu Cohort 1, odwala asanu ndi awiri (47%) adawonetsa kusintha kwapawiri kapena kukulirapo kuchokera pazoyambira pa Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (DRSS), mapeto oyambirira a phunziro, poyerekeza ndi ziro mwa odwala asanu (0%) mu gulu loyang'anira. Wodwala mmodzi (7%) yemwe amamwa mankhwala a RGX-314 akupitiriza kusonyeza kusintha kwa magawo anayi. Chiwerengero cha odwala a Cohort 1 omwe amamwa mankhwala a RGX-314 omwe akupindula osachepera masitepe awiri pa miyezi isanu ndi umodzi mu maso ochiritsidwa a RGX-314 (47%) adawonjezeka kuchokera ku zotsatira za miyezi itatu (33%). Kuwongolera kwa magawo awiri mu DRSS kwavomerezedwa ngati mathero ofunikira ndi a FDA pamayesero azachipatala a DR.

Odwala asanu ndi awiri omwe anali ndi NPDR (DR severity level 47-53) poyambira, 57% ya odwala adawonetsa njira ziwiri kapena zowonjezereka kuchokera ku DRSS yoyambira pa miyezi isanu ndi umodzi pambuyo pa ulamuliro wa RGX-314. Odwala asanu ndi atatu omwe anali ndi PDR (DR severity level ≥ 61) poyambira, 38% ya odwala adawonetsa njira ziwiri kapena zowonjezereka pa miyezi isanu ndi umodzi pambuyo pa ulamuliro wa RGX-314. 

Pakatha miyezi isanu ndi umodzi pambuyo pa utsogoleri wa RGX-314, odwala a Cohort 1 adawonetsa kusintha kosasunthika kwa BCVA ya + 0.3 makalata poyerekeza ndi chiyambi, pamene odwala asanu mu mkono woyang'anitsitsa anawonetsa kusintha kosasunthika kwa BCVA ya -2.0 makalata poyerekeza ndi chiyambi.

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mkonzi

Mkonzi wamkulu wa eTurboNew ndi Linda Hohnholz. Amakhala ku eTN HQ ku Honolulu, Hawaii.

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