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

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT05324592

Collaborator

(none)

Enrollment

Location

Arms

10.9

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: 9MW0813 Drug: Aflibercept	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Feb 26, 2021

Actual Primary Completion Date :

Sep 24, 2021

Actual Study Completion Date :

Jan 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 9MW0813	Drug: 9MW0813 The active ingredient of 9MW0813 injection is recombinant human vascular endothelial growth factor receptor-antibody fusion protein. One dose(2mg) of the drug will be injected intravitreously.
Active Comparator: aflibercept	Drug: Aflibercept Aflibercept (trade name: Eylea®/EYLEA®) is an anti-VEGF drug developed by Regeneron/Bayer. It is a fusion protein of human VEGFR1 and VEGFR2 extracellular domains and human immunoglobulin Fc segment genes. One dose(2mg) of the drug will be injected intravitreously. Other Names: Eylea®

Arm

Intervention/Treatment

Experimental: 9MW0813

Drug: 9MW0813

The active ingredient of 9MW0813 injection is recombinant human vascular endothelial growth factor receptor-antibody fusion protein. One dose(2mg) of the drug will be injected intravitreously.

Active Comparator: aflibercept

Drug: Aflibercept

Aflibercept (trade name: Eylea®/EYLEA®) is an anti-VEGF drug developed by Regeneron/Bayer. It is a fusion protein of human VEGFR1 and VEGFR2 extracellular domains and human immunoglobulin Fc segment genes. One dose(2mg) of the drug will be injected intravitreously.

Other Names:

Eylea®

Outcome Measures

Primary Outcome Measures

Incidence of adverse events [baseline to week 6]

Secondary Outcome Measures

Peak Plasma Concentration（Cmax） of 9MW0813 and aflibercept [baseline to week 6]
Pharmacokinetic measure
Area under the plasma concentration versus time curve (AUC) 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Main inclusion criteria：

Diagnosed with type 1 or type 2 diabetes with HbA1c ≤ 11.0%;
Use ETDRS chart BCVA ≥ 19 letters and ≤ 73 letters (approximately equivalent to Snellen chart equivalent 20/40 to 20/400);
Central retinal thickness (CRT) ≥ 300 μm, (using spectral domain optical coherence tomography);
BCVA ≥ 24 letters in the non-study eye (approximately 20/320 equivalent on the Snellen chart).

Main exclusion criteria:

with proliferative diabetic retinopathy (PDR), excluding inactive, fibrotic PDR;
Vitreous hemorrhage within 30 days before the first administration;
Structural retinal damage involving the fovea (such as retinal pigment epithelium (RPE) atrophy, retinal fibrosis, laser scarring, dense hard exudates), or the investigator believes that the study eye has other factors that may hinder vision after macular edema subsides increased retinal damage;
Existing ophthalmic conditions other than diabetic retinopathy that cause macular edema or vision changes (such as retinal vein occlusion (RVO), choroidal neovascularization, retinal detachment, macular hole, macular retinal traction, epiretinal membrane, etc.) ;
There are iris neovascularization;
Uncontrolled glaucoma (defined as intraocular pressure ≥ 25mmHg after anti-glaucoma drug treatment) or glaucoma-causing cup/optic disc ratio of the study eye >0.8 or previous glaucoma filtering surgery (such as trabeculae); excision, sclerectomy, etc.);
The investigator believes that the cataract may affect the judgment of the examination or test results, or requires surgical treatment during the test;
Aphakia (excluding intraocular lens) or posterior capsule defect (except for YAG laser posterior capsulotomy after intraocular lens implantation within 30 days);
History of vitrectomy.