Evaluation of RC28-E Injection in Diabetic Macular Edema

Summary

This is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy, safety and pharmacokinetics of RC28-E injection in the treatment of patients with diabetic macular edema.

Timeline

Start

2021-03-17

Primary completion

2023-07-31

Completion

2023-07-31

Outcome

Missed primary endpoint

paper Mean improvements in BCVA in the RC28-E groups at week 24 were 7.1, 11.0, 7.4 and 10.5 letters for 1.0mgQ8, 1.0mgPRN, 2.0mgQ8 and 2.0mgPRN regimens, respectively, versus 9.7 letters for the conbercept group (p=0.146). PMID 40122579 ↗

paper By week 52, the RC28-E groups exhibited respective mean BCVA enhancements of 5.5, 9.5, 9.2 and 9.7 letters, compared with 8.4 letters of the conbercept group (p=0.469). PMID 40122579 ↗

Publications

• Zhang W, Cheng S, Gu X, Liu X, Dai H, Zhuang W, Sun B, Gao L, Sun X, Zhang M, Song Z, Wang W, Li L, Chen H, Fang J, Chen Y. Simultaneous inhibition of fibroblast growth factor-2 and vascular endothelial growth factor-a with RC28-E in diabetic macular edema: a phase 2 randomised trial. Br J Ophthalmol. 2025 Jun 23;109(7):784-790. doi: 10.1136/bjo-2024-326006.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Conbercept	Protein / enzyme biologic	0.5 mg	Intravitreal
Subject	RC28-E	Protein / enzyme biologic	1 mg	Intravitreal
Subject	RC28-E	Protein / enzyme biologic	2 mg	Intravitreal

Indications