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

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

9MW0813

Aflibercept

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring aflibercept, biosimilarity, safety, pharmacokinetics, pharmacodynamics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Beijing tongren hospital affliated to capital medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

9MW0813

aflibercept

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events

Secondary Outcome Measures

Peak Plasma Concentration（Cmax） of 9MW0813 and aflibercept

Pharmacokinetic measure

Area under the plasma concentration versus time curve (AUC) of 9MW0813 and aflibercept

Pharmacokinetic measure

Immunogenicity of IVT injection of 9MW0813 and aflibercept

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)

Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score

Full Information

NCT ID

NCT05324592

First Posted

March 30, 2022

Last Updated

April 5, 2022

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05324592

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

February 26, 2021 (Actual)

Primary Completion Date

September 24, 2021 (Actual)

Study Completion Date

January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

Keywords

aflibercept, biosimilarity, safety, pharmacokinetics, pharmacodynamics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

9MW0813

Arm Type

Experimental

Arm Title

aflibercept

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

9MW0813

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Aflibercept

Other Intervention Name(s)

Eylea®

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of adverse events

Time Frame

baseline to week 6

Secondary Outcome Measure Information:

Title

Peak Plasma Concentration（Cmax） of 9MW0813 and aflibercept

Description

Pharmacokinetic measure

Time Frame

baseline to week 6

Title

Area under the plasma concentration versus time curve (AUC) of 9MW0813 and aflibercept

Description

Pharmacokinetic measure

Time Frame

baseline to week 6

Title

Immunogenicity of IVT injection of 9MW0813 and aflibercept

Description

Anti-drug antibody (ADA) in serum is detected, ADA-positive samples will be subjected to titer analysis and neutralizing antibody (Nab) analysis

Time Frame

baseline to week 6

Title

Change from Baseline in Best Corrected Visual Acuity (BCVA)

Description

Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score

Time Frame

baseline to week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Beijing tongren hospital affliated to capital medical university

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100000

Country

China

12. IPD Sharing Statement

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

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