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

NCT05324592 | Completed Phase 1 DMC

• 1 other identifier: 9MW0813-2020-CP101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Macular Edema

Keywords

aflibercept; biosimilarity; safety; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  baseline to week 6

Secondary Outcomes (4)

• Peak Plasma Concentration（Cmax） of 9MW0813 and aflibercept

  baseline to week 6

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

  baseline to week 6

• Immunogenicity of IVT injection of 9MW0813 and aflibercept

  baseline to week 6

• Change from Baseline in Best Corrected Visual Acuity (BCVA)

  baseline to week 6

Study Arms (2)

9MW0813

EXPERIMENTAL

Drug: 9MW0813

aflibercept

ACTIVE COMPARATOR

Drug: Aflibercept

Interventions

9MW0813 DRUG

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.

9MW0813

Aflibercept DRUG

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.

Also known as: Eylea®

aflibercept

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (1)

Beijing tongren hospital affliated to capital medical university

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Interventions

aflibercept

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 12, 2022
• Study Start: February 26, 2021
• Primary Completion: September 24, 2021
• Study Completion: January 25, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-03

Locations

CN (1)