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

Diabetic Macular Edema Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05324592
• Other study ID #: 9MW0813-2020-CP101
• Status: Completed
• Phase: Phase 1
• Start date: February 26, 2021
• Est. completion date: January 25, 2022

Study information

• Verified date: March 2022
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 25, 2022
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Main inclusion criteria:

1. Diagnosed with type 1 or type 2 diabetes with HbA1c = 11.0%;

2. Use ETDRS chart BCVA = 19 letters and = 73 letters (approximately equivalent to Snellen chart equivalent 20/40 to 20/400);

3. Central retinal thickness (CRT) = 300 µm, (using spectral domain optical coherence tomography);

4. BCVA = 24 letters in the non-study eye (approximately 20/320 equivalent on the Snellen chart).

Main exclusion criteria:

1. with proliferative diabetic retinopathy (PDR), excluding inactive, fibrotic PDR;

2. Vitreous hemorrhage within 30 days before the first administration;

3. 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;

4. 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.) ;

5. There are iris neovascularization;

6. 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.);

7. The investigator believes that the cataract may affect the judgment of the examination or test results, or requires surgical treatment during the test;

8. Aphakia (excluding intraocular lens) or posterior capsule defect (except for YAG laser posterior capsulotomy after intraocular lens implantation within 30 days);

9. History of vitrectomy.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing tongren hospital affliated to capital medical university	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Mabwell (Shanghai) Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		baseline to week 6
Secondary	Peak Plasma Concentration(Cmax) of 9MW0813 and aflibercept	Pharmacokinetic measure	baseline to week 6
Secondary	Area under the plasma concentration versus time curve (AUC) of 9MW0813 and aflibercept	Pharmacokinetic measure	baseline to week 6
Secondary	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	baseline to week 6
Secondary	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	baseline to week 6