Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)

NCT02194634 ↗

Phase 3 Unknown 248 enrolled Chengdu Kanghong Biotech Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is designed to assess safety and efficacy of intravitreal injection of Conbercept on visual acuity and anatomic outcomes in patients with diabetic macular edema (DME) .

Timeline

Start: 2014-07
Primary completion: 2016-12
Completion: 2017-09

Outcome

Met primary endpoint

paper Significant improvement in mean change in BCVA from baseline to month 12 was observed in the sham/conbercept group (8.2±9.5 letters) PMID 34001667 ↗

paper its efficacy was better than that of laser photocoagulations PMID 34001667 ↗

Publications

Liu K, Wang H, He W, Ye J, Song Y, Wang Y, Liu X, Wu Z, Chen S, Fan K, Liu Y, Zhang F, Li Z, Liu L, Zhang J, Zhang X, Ye J, Liang X, Li X, Ke X, Wu Q, Li J, Tao S, Wang X, Rosenfeld P, Heier JS, Kaiser P, Xu X. Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study. Br J Ophthalmol. 2022 Oct;106(10):1436-1443. doi: 10.1136/bjophthalmol-2020-318690. Epub 2021 May 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Conbercept	Protein / enzyme biologic	0.5 mg	Intravitreal