Safety and Efficacy of 9MW0813 in Subjects With Diabetic Macular Edema

Phase 1

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: 9MW0813; Drug: Aflibercept

• Registration Number: NCT05324592
• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Brief Summary

A multicenter, randomized, double-blind, parallel-controlled phase I trial comparing the safety, pharmacokinetics and efficacy of 9MW0813 and aflibercept (EYLEA®) after a single dose in patients with diabetic macular edema (DME).

Detailed Description

This is a multi-center, randomized, double-blind, parallel controlled Phase I clinical trial.

The primary objective is to compare the safety of a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients.

The secondary objectives are to comparing the pharmacokinetic profile, immunogenicity and efficacy of a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients.

Study Timeline

• Study Start: 2021-02-26
• Primary Completion: 2021-09-24
• Study Completion: 2022-01-25
• Status Verified: 2022-03
• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-05
• Study First Posted: 2022-04-12
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
9MW0813	9MW0813	-
aflibercept	Aflibercept	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	baseline to week 6

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of 9MW0813 and aflibercept	baseline to week 6	Pharmacokinetic measure
Change from Baseline in Best Corrected Visual Acuity (BCVA)	baseline to week 6	Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score
Peak Plasma Concentration（Cmax） of 9MW0813 and aflibercept	baseline to week 6	Pharmacokinetic measure
Immunogenicity of IVT injection of 9MW0813 and aflibercept	baseline to week 6	Anti-drug antibody (ADA) in serum is detected, ADA-positive samples will be subjected to titer analysis and neutralizing antibody (Nab) analysis

Trial Locations

Locations (1)

Beijing tongren hospital affliated to capital medical university; 🇨🇳 Beijing, Beijing, China