Sabon Maganin Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciki yana Nuna Kyakkyawan sakamako

0 banza 3 | eTurboNews | eTN
Avatar na Linda Hohnholz
Written by Linda Hohnholz

REGENXBIO Inc. ya ba da sanarwar ƙarin ingantattun bayanan wucin gadi daga ci gaba da gwajin Phase II ALTITUDE™ na RGX-314 don kula da ciwon sukari na retinopathy (DR) ba tare da ci gaba da kamuwa da ciwon sukari ba (CI-DME) ta amfani da isar da suprachoroidal a ofis. Ana gabatar da bayanan a taron Angiogenesis, Exudation, da Degeneration 2022 ta Michael A. Klufas, MD, Sabis na Retina, Asibitin Ido na Wills, Mataimakin Farfesa na Ophthalmology, Jami'ar Thomas Jefferson. Ana binciken RGX-314 a matsayin yuwuwar jiyya na jiyya na lokaci ɗaya don maganin jikawar macular degeneration da DR.              

Tsarin Nazari da Sabunta Tsaro daga Mataki na II ALTITUDE Gwajin RGX-314 don Jiyya na DR Amfani da Isar da Suprachoroidal

ALTITUDE cibiyar sadarwa ce da yawa, alamar buɗewa, bazuwar, gwajin haɓaka kashi-kashi mai sarrafawa yana kimanta inganci, aminci da haƙurin isar da suprachoroidal na RGX-314 ta amfani da SCS Microinjector® a cikin marasa lafiya tare da ganowar DR na matsakaicin matsakaici ko mai tsanani mai ciwon sukari mara haɓaka. retinopathy (NPDR) ko ƙananan ƙwayar cutar ciwon sukari (PDR). Marasa lafiya ashirin a cikin Cohort 1 an bazu don karɓar RGX-314 a matakin kashi na 2.5 × 1011 kwafin genomic a kowane ido (GC / ido) tare da kulawar kulawa a cikin rabo na 3: 1. Ƙungiyar 2 za ta haɗa da marasa lafiya 20 da aka bazu don karɓar RGX-314 a matakin ƙarar kashi na 5 × 1011 GC / ido tare da kulawar kulawa a cikin rabo na 3: 1. An ƙirƙira ƙungiyar 3 don kimanta RGX-314 a matakin kashi ɗaya kamar Cohort 2 a cikin marasa lafiya 20 waɗanda ke kawar da antibody (NAb) tabbatacce. Ana ci gaba da yin rajista a cikin Ƙungiyoyin 2 da 3. Marasa lafiya a cikin wannan gwaji ba sa karɓar maganin rigakafin rigakafi na corticosteroid kafin ko bayan gudanar da RGX-314.

Tun daga Janairu 18, 2022, RGX-314 an ba da rahoton cewa an jure shi da kyau a cikin Ƙungiyar 1. An ba da rahoton abubuwa biyu masu tsanani a cikin marasa lafiya biyu, dukansu ba a la'akari da su da alaka da kwayoyi. Daga cikin marasa lafiya a cikin Cohort 1 da aka yi amfani da su tare da RGX-314, ba a sami kumburin intraocular ba. Kamar yadda aka ruwaito a baya, wani majiyyaci ya sami wani m hali na episcleritis wanda ya warware tare da Topical corticosteroids. Maganin ido na yau da kullun ya haifar da mummunan al'amura a cikin ido na binciken har tsawon watanni shida ba a yi la'akari da alaƙa da ƙwayoyi ba kuma galibi suna da laushi. Waɗannan sun haɗa da zubar jini na conjunctival da hyperemia na conjunctival.

Takaitacciyar Bayanai don Ƙungiyar 1 a Wata shida

A cikin watanni shida, daga cikin marasa lafiya na 15 da aka yi amfani da su tare da RGX-314 a cikin Cohort 1, marasa lafiya bakwai (47%) sun nuna haɓakar matakai biyu ko mafi girma daga tushe akan Nazarin Farko na Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon Ciwon sukari (DRSS), farkon ƙarshen binciken, idan aka kwatanta da sifili na marasa lafiya biyar (0%) a cikin rukunin kulawa na lura. Majiyyaci ɗaya (7%) da aka yi amfani da shi tare da RGX-314 ya ci gaba da nuna haɓakar matakai huɗu. Adadin marasa lafiya na Cohort 1 da aka yi amfani da su tare da RGX-314 suna samun ci gaba aƙalla mataki biyu a cikin watanni shida a cikin RGX-314 da aka kula da idanu (47%) ya karu daga sakamakon watanni uku da aka bayar a baya (33%). An karɓi haɓakar mataki na 2 a cikin DRSS azaman muhimmin mahimmin ƙarshen ta FDA don gwajin asibiti na DR.

A cikin marasa lafiya bakwai waɗanda ke da NPDR (DR mai tsanani matakin 47-53) a asali, 57% na marasa lafiya sun nuna mataki biyu ko mafi girma daga DRSS na asali a watanni shida bayan gudanarwa na RGX-314. A cikin marasa lafiya takwas waɗanda ke da PDR (DR mai tsanani matakin ≥ 61) a asali, 38% na marasa lafiya sun nuna mataki biyu ko mafi girma a cikin watanni shida bayan gudanarwa na RGX-314. 

A cikin watanni shida bayan gudanarwa na RGX-314, marasa lafiya na Cohort 1 sun nuna alamar canji a cikin BCVA na + 0.3 haruffa idan aka kwatanta da asali, yayin da marasa lafiya biyar a cikin kulawar kulawa da kulawa sun nuna alamar canji a cikin BCVA na -2.0 haruffa idan aka kwatanta da asali.

Game da marubucin

Avatar na Linda Hohnholz

Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

Labarai
Sanarwa na
bako
0 comments
Bayanin Cikin Lissafi
Duba duk maganganu
0
Za a son tunanin ku, don Allah sharhi.x
()
x
Share zuwa...