[Translation] A multicenter, randomized, double-blind, parallel-controlled Phase I comparison of the safety, pharmacokinetics, and efficacy of 9MW0813 and aflibercept (EYLEA®) after a single dose in patients with diabetic macular edema (DME) clinical research
主要目的:比较在DME患者中单次玻璃体腔内注射(IVT)9MW0813注射液和阿柏西普眼内注射溶液(EYLEA®)后的安全性。
次要目的:
(1)比较在DME患者中单次玻璃体腔内注射(IVT)9MW0813注射液和阿柏西普眼内注射溶液(EYLEA®)后的药代动力学特征;
(2)比较在DME患者中单次玻璃体腔内注射(IVT)9MW0813注射液和阿柏西普眼内注射溶液(EYLEA®)后的免疫原性;
(3)初步评价在DME患者中单次玻璃体腔内注射(IVT)9MW0813注射液和阿柏西普眼内注射溶液(EYLEA®)后的临床有效性。
[Translation] Main objective: To compare the safety of a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients.
Secondary purpose:
(1) To compare the pharmacokinetic characteristics after a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients;
(2) To compare the immunogenicity after a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients;
(3) Preliminary evaluation of the clinical efficacy after a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients.