[Translation] A randomized, double-blind, parallel, positive-controlled, multicenter phase III clinical trial comparing the efficacy and safety of JZB05 and aflibercept in patients with diabetic macular edema
主要目的:
比较在DME患者中玻璃体腔注射JZB05注射液和阿柏西普眼内注射溶液(EYLEA®)的临床有效性的相似性。
临床有效性的相似性评价基于:给予JZB05和EYLEA®后第8周采用ETDRS视力表测得的最佳矫正视力(BCVA)较基线改善的字母数。
[Translation] Primary objective:
To compare the similarity of clinical effectiveness of intravitreal JZB05 injection and aflibercept intraocular injection solution (EYLEA®) in patients with DME.
The similarity of clinical effectiveness was evaluated based on the number of letters of improvement in best corrected visual acuity (BCVA) measured by the ETDRS eye chart compared with baseline at week 8 after administration of JZB05 and EYLEA®.