[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®.

Start Date09 Oct 2023

Sponsor / Collaborator

Shanghai Jingze Biotechnology Co., Ltd.

[+1]

CTR20221460 / Active, not recruitingPhase 1

一项随机、双盲、平行两组、阳性对照，比对JZB05和阿柏西普在糖尿病黄斑水肿患者中的安全性、药代动力学和药效学的I期临床试验

[Translation] A randomized, double-blind, parallel-group, positive-controlled phase I clinical trial comparing the safety, pharmacokinetics, and pharmacodynamics of JZB05 and aflibercept in patients with diabetic macular edema

主要目的： 1、比较糖尿病黄斑水肿（DME）患者玻璃体腔单次注射JZB05和阿柏西普的临床安全性。 2、比较糖尿病黄斑水肿（DME）患者玻璃体腔单次注射JZB05和阿柏西普的系统药代动力学（PK）特征；次要目的：探索糖尿病黄斑水肿（DME）患者玻璃体腔单次注射JZB05后的初步疗效。

[Translation]

Main objectives: 1. To compare the clinical safety of a single intravitreal injection of JZB05 and aflibercept in patients with diabetic macular edema (DME). 2. To compare the systemic pharmacokinetic (PK) characteristics of a single intravitreal injection of JZB05 and aflibercept in patients with diabetic macular edema (DME); Secondary objectives: To explore the preliminary efficacy of a single intravitreal injection of JZB05 in patients with diabetic macular edema (DME).

Start Date01 Jul 2022

Sponsor / Collaborator

Shanghai Jingze Biotechnology Co., Ltd.

[+1]

100 Clinical Results associated with Aflibercept biosimilar(Jingze Biotech)

100 Translational Medicine associated with Aflibercept biosimilar(Jingze Biotech)

100 Patents (Medical) associated with Aflibercept biosimilar(Jingze Biotech)

100 Deals associated with Aflibercept biosimilar(Jingze Biotech)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX44 S01LA05	-

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	Phase 3	CN	Shanghai Jingze Biotechnology Co., Ltd.	09 Oct 2023
Diabetic macular oedema	Phase 3	CN	Chengdu Zeyan Biotechnology Co., Ltd.	09 Oct 2023

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