Back to resultsEfficacy and Safety of 9MW0813 in Subjects With Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
9MW0813
Aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring aflibercept, biosimilarity
Eligibility Criteria
Main Inclusion Criteria:
- Age ≥ 18 years old, gender is not limited;
- Diagnosed with type 1 or type 2 diabetes, and HbA1c≤10.0%;
- The visual impairment of the study eye was mainly caused by diabetic macular edema;
- OCT examination at screening and baseline, diabetic macular edema involving the fovea of the study eye, and central retinal thickness (CRT) ≥ 300 μm (using SD-OCT);
- The best-corrected visual acuity (BCVA) of the study eye at screening and baseline measured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart was between 73 and 24 letters (inclusive) (approximately equivalent to Snellen's visual acuity) score 20/40 to 20/320).
Main Exclusion Criteria:
- Active proliferative diabetic retinopathy (PDR) exists in the study eye;
- Structural damage to the fovea in the study eye, which may not improve BCVA after resolution of macular edema (eg, retinal pigment epithelial cell atrophy, subretinal fibrosis or scarring, significant macular ischemia, or organizing hard exudates) );
- The study eye has any ocular disease or past medical history other than diabetic macular edema, and the investigator believes that it may affect the macular assessment or central vision (such as: cataract, retinal vascular occlusion, retinal detachment, macular traction, macular epiretinal membrane , macular hole, macular hemorrhage, preretinal fibrous proliferation involving the macula, various choroidal neovascularization);
- The study eye has erythema of the iris, vitreous hemorrhage or traction retinal detachment;
- The study eye has poorly controlled glaucoma (defined as intraocular pressure ≥25mmHg after anti-glaucoma drug treatment);
- The study eye has received or may have received glaucoma filtration surgery (such as: trabeculectomy, sclerectomy and non-penetrating trabecular surgery) during the study period;
- The study eye has received vitreoretinal surgery in the past;
- Aphakic (except intraocular lens) in the research eye.
Sites / Locations
- Beijing tongren hospital affliated to capital medical universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
9MW0813
aflibercept
Arm Description
Outcomes
Primary Outcome Measures
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
Change from Baseline in Central Retinal Thickness（CRT）
Change from Baseline in CRT as measured by optical coherence tomography
Secondary Outcome Measures
Incidence of adverse events
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
Full Information
NCT ID
NCT05324774
First Posted
March 30, 2022
Last Updated
April 5, 2022
Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05324774
Brief Title
Efficacy and Safety of 9MW0813 in Subjects With Diabetic Macular Edema
Official Title
Phase III Clinical Study of the Efficacy and Safety of 9MW0813 and Aflibercept (EYLEA®) in Patients With Diabetic Macular Edema (DME) in a Multicenter, Randomized, Double-blind, Parallel Active-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Phase III clinical study of the efficacy and safety of 9MW0813 and aflibercept (EYLEA®) in patients with diabetic macular edema (DME) in a multicenter, randomized, double-blind, parallel active-controlled study.
Detailed Description
This is a multi-center, randomized, double-blind, parallel controlled phase 3 clinical trial.
The primary objective is to compare the similarity of clinical efficacy of intravitreal 9MW0813 injection and aflibercept intraocular injection (EYLEA®) in DME patients.
The secondary objectives are to compare the similarity of safety, immunogenicity and pharmacokinetics of intravitreal 9MW0813 injection and aflibercept intraocular injection (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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
346 (Anticipated)
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.
9 doses(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.
9 doses(2mg) of the drug will be injected intravitreously.
Primary Outcome Measure Information:
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
8 weeks
Title
Change from Baseline in Central Retinal Thickness（CRT）
Description
Change from Baseline in CRT as measured by optical coherence tomography
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
52 weeks
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
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Age ≥ 18 years old, gender is not limited;
Diagnosed with type 1 or type 2 diabetes, and HbA1c≤10.0%;
The visual impairment of the study eye was mainly caused by diabetic macular edema;
OCT examination at screening and baseline, diabetic macular edema involving the fovea of the study eye, and central retinal thickness (CRT) ≥ 300 μm (using SD-OCT);
The best-corrected visual acuity (BCVA) of the study eye at screening and baseline measured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart was between 73 and 24 letters (inclusive) (approximately equivalent to Snellen's visual acuity) score 20/40 to 20/320).
Main Exclusion Criteria:
Active proliferative diabetic retinopathy (PDR) exists in the study eye;
Structural damage to the fovea in the study eye, which may not improve BCVA after resolution of macular edema (eg, retinal pigment epithelial cell atrophy, subretinal fibrosis or scarring, significant macular ischemia, or organizing hard exudates) );
The study eye has any ocular disease or past medical history other than diabetic macular edema, and the investigator believes that it may affect the macular assessment or central vision (such as: cataract, retinal vascular occlusion, retinal detachment, macular traction, macular epiretinal membrane , macular hole, macular hemorrhage, preretinal fibrous proliferation involving the macula, various choroidal neovascularization);
The study eye has erythema of the iris, vitreous hemorrhage or traction retinal detachment;
The study eye has poorly controlled glaucoma (defined as intraocular pressure ≥25mmHg after anti-glaucoma drug treatment);
The study eye has received or may have received glaucoma filtration surgery (such as: trabeculectomy, sclerectomy and non-penetrating trabecular surgery) during the study period;
The study eye has received vitreoretinal surgery in the past;
Aphakic (except intraocular lens) in the research eye.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbin Wei, MD/PhD
Phone
010-58268486
Ext
8001
Email
tr_weiwenbin@163.com
Facility Information:
Facility Name
Beijing tongren hospital affliated to capital medical university
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbin Wei, MD/PhD
Phone
010-58268486
Ext
8001
Email
tr_weiwenbin@163.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of 9MW0813 in Subjects With Diabetic Macular Edema
We'll reach out to this number within 24 hrs