A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants With Diabetic Macular Edema
NCT ID: NCT06422507
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
333 participants
INTERVENTIONAL
2024-05-29
2026-03-22
Brief Summary
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Diabetic macular edema (DME) is a diabetes-related eye disorder. In DME, the macula, which is the central part of the retina at the back of the eye, swells up resulting in vision problems. This happens due to leakage of fluid from damaged blood vessels.
The study treatment, 8 milligram (mg) aflibercept is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye.
A lower dose of aflibercept (2 mg) is already approved for the treatment of DME. Based on the findings of another study, the higher dose of aflibercept (8 mg) is expected to reduce the frequency of injections required for treating DME while being equally safe and working as well as the lower dose. The higher dose could make it easier to treat DME and improve quality of life for people with DME.
The main purpose of this study is to learn if high-dose (8 mg) aflibercept given every 16 weeks works as well as low-dose (2 mg) aflibercept given every 8 weeks in Chinese participants.
For this, the researchers will compare the change in participants' 'best corrected visual acuity' (BCVA) after 48 weeks of starting the treatment. BCVA is the clearest vision a participant can have with the help of corrective lenses, such as glasses. It will be measured by the number of letters the participant can read on an eye chart. This is known as their Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
Participants will be randomly (by chance) assigned to one of two treatment groups to receive study treatment as an injection into the eye up to Week 56:
* 2 mg aflibercept every 8 weeks after receiving 5 initial monthly doses
* 8 mg aflibercept every 16 weeks after receiving 3 initial monthly doses
Each participant will be in the study for around 63 weeks with up to 18 visits to the study site. This includes:
* one visit up to 21 days before the treatment starts during which the doctors will confirm that the participant can take part in the study
* 16 visits during which the treatment will be given. Most of these visits will have a gap of 4 weeks except for one visit that will happen a few days after the previous visit
* one visit 4 weeks after the treatment ends
During the study, the doctors and their study team will:
* check the participants' vision and their overall eye health using different eye tests
* check participants' health by performing tests such as blood and urine tests
* ask the participants questions about the disease and study treatment and how these impact their quality of life
* ask the participants what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment.
Access to study treatment after the end of this study is not planned. Participants can switch to available approved treatments for DME.
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Detailed Description
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Primary Objective: The primary objective of the study is to determine if treatment with HD aflibercept at intervals of 16 weeks provides non-inferior best-corrected visual acuity (BCVA) compared to 2 mg aflibercept dosed every 8 weeks in Chinese participants
Secondary Objectives:
* To determine the effect of HD aflibercept vs. 2 mg aflibercept on anatomic and other visual measures of response;
* To evaluate the safety, immunogenicity and pharmacokinetics (PK) of HD aflibercept in Chinese participants.
Primary endpoint:
* Change from baseline in BCVA by ETDRS letter score at Week 48
Secondary endpoints:
* Change from baseline in BCVA by ETDRS letter score at Week 60
* Participants gaining ≥15 letters at Week 48 and Week 60
* Participants achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Week 48
* Participants with no IRF and/or no SRF in the center subfield at Week 48
* Change from baseline in central subfield thickness (CST) at Week 48
* Change from baseline in leakage on fluorescein angiography (FA) at Week 48
* Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score at Week 48
* Occurrence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Weeks 48 and 60
* Participants developing a treatment-emergent ADA response or Nabs to aflibercept through EOS at Week 60
* Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound, and total aflibercept from baseline through Week 48 This study is a phase 3, multi-center, randomized, double-masked, active-controlled study in Chinese participants with DME involving the center of the macula to investigate the efficacy and safety of HD aflibercept versus 2 mg aflibercept.
The primary objective of the study is to determine if treatment with HD aflibercept at 16 week intervals provides non-inferior BCVA compared to 2 mg aflibercept dosed every 8 weeks in Chinese participants.
322 eligible participants randomized in a 1:1 ratio to the following 2 treatment groups:
1. 2q8: 2 mg aflibercept every 8 weeks following 5 initial monthly doses (n=161) and
2. HDq16: HD aflibercept every 16 weeks following 3 initial monthly doses (n=161). The study consists of a screening period, a treatment period, and an end of study (EOS) visit at Week 60. The study duration for a participant is approximately 63 weeks. The EOS is defined as the last visit of the last participant. No study treatment will be administered at the EOS visit at Week 60.
HD aflibercept is the sponsor's study intervention under investigation. The following intervention groups are included in the study:
* 2 mg aflibercept every 8 weeks (2q8)
* 8 mg aflibercept every 16 weeks (HDq16)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
To preserve masking, sham injections will be performed for all participants at treatment visits in which participants do not receive an active injection through Week 56.
Study Groups
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2 mg aflibercept
Participants that will be enrolled to this treatment arm will receive 2 mg aflibercept every 8 weeks following 5 initial monthly doses starting at Baseline (visit 2) (2q8) for the chosen "study eye". Randomization will be stratified according to baseline Central subfield thickness (CST) (\<400 µm, ≥400 µm), baseline Best corrected visual acuity (BCVA) (\<60 vs. ≥60 ETDRS letters) and prior treatment for DME.
2 mg aflibercept (EYLEA, BAY 86-5321)
Aflibercept 2 mg is the sponsor's active comparator. Dose formulation: solution in vial. Unit dose strength: 40 mg/mL, Dosage Level: 2 mg (50 µL), Route of Administration: Intravitreal (IVT) injection every 8 weeks following 5 initial monthly doses. Packaging/ Labeling: Study Intervention will be provided in sterile 2 mL glass vials. Each vial will be labeled as required per country requirement. Aflibercept 2 mg for the non-study "fellow eye" treatment is considered an auxiliary medicinal product (AxMP) in this study. Fellow eye treatment will be allowed with 2 mg aflibercept, at the investigator's discretion for indications approved by governing authorities. The treated fellow eye will not be considered an additional study eye.
Sham
To preserve masking, sham injections will be performed for all participants at treatment visits in which participants do not receive an active injection through Week 56. Sham kits will be assigned for visits requiring sham injections. The sham kits are empty but should be handled in the same way as the active study intervention kits.
Sham injections will be given on visits when an active injection is not planned. During the study treatment period all participants will receive either an active injection (8 mg or 2 mg aflibercept) or a sham injection (for masking purposes) following their assigned treatment group and eligibility for Dose regimen modification (DRM).
8 mg aflibercept (high dose)
Participants that will be enrolled to this treatment arm will receive 8 mg (high dose - HD) aflibercept every 16 weeks following 3 initial monthly doses, starting at Baseline (Visit 2) (HDq16) for the chosen "study eye". Randomization will be stratified according to baseline Central subfield thickness (CST) (\<400 µm, ≥400 µm), baseline Best corrected visual acuity (BCVA) (\<60 vs. ≥60 ETDRS letters) and prior treatment for DME.
8 mg aflibercept (BAY 86-5321) (High Dose)
High-dose (HD) aflibercept is the sponsor's study intervention under investigation. Dose formulation: solution in vial. Unit dose strength: 114.3 mg/mL, Dosage Level: 8 mg (70 µL), Route of Administration: Intravitreal (IVT) injection every 16 weeks following 3 initial monthly doses. Packaging/ Labeling: Study Intervention will be provided in sterile 3 mL glass vials. Each vial will be labeled as required per country requirement.
Sham
To preserve masking, sham injections will be performed for all participants at treatment visits in which participants do not receive an active injection through Week 56. Sham kits will be assigned for visits requiring sham injections. The sham kits are empty but should be handled in the same way as the active study intervention kits.
Sham injections will be given on visits when an active injection is not planned. During the study treatment period all participants will receive either an active injection (8 mg or 2 mg aflibercept) or a sham injection (for masking purposes) following their assigned treatment group and eligibility for Dose regimen modification (DRM).
Interventions
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8 mg aflibercept (BAY 86-5321) (High Dose)
High-dose (HD) aflibercept is the sponsor's study intervention under investigation. Dose formulation: solution in vial. Unit dose strength: 114.3 mg/mL, Dosage Level: 8 mg (70 µL), Route of Administration: Intravitreal (IVT) injection every 16 weeks following 3 initial monthly doses. Packaging/ Labeling: Study Intervention will be provided in sterile 3 mL glass vials. Each vial will be labeled as required per country requirement.
2 mg aflibercept (EYLEA, BAY 86-5321)
Aflibercept 2 mg is the sponsor's active comparator. Dose formulation: solution in vial. Unit dose strength: 40 mg/mL, Dosage Level: 2 mg (50 µL), Route of Administration: Intravitreal (IVT) injection every 8 weeks following 5 initial monthly doses. Packaging/ Labeling: Study Intervention will be provided in sterile 2 mL glass vials. Each vial will be labeled as required per country requirement. Aflibercept 2 mg for the non-study "fellow eye" treatment is considered an auxiliary medicinal product (AxMP) in this study. Fellow eye treatment will be allowed with 2 mg aflibercept, at the investigator's discretion for indications approved by governing authorities. The treated fellow eye will not be considered an additional study eye.
Sham
To preserve masking, sham injections will be performed for all participants at treatment visits in which participants do not receive an active injection through Week 56. Sham kits will be assigned for visits requiring sham injections. The sham kits are empty but should be handled in the same way as the active study intervention kits.
Sham injections will be given on visits when an active injection is not planned. During the study treatment period all participants will receive either an active injection (8 mg or 2 mg aflibercept) or a sham injection (for masking purposes) following their assigned treatment group and eligibility for Dose regimen modification (DRM).
Eligibility Criteria
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Inclusion Criteria
* Chinese participants with type 1 or type 2 diabetes mellitus and diabetic macular edema (DME) with central involvement defined as CST ≥300 µm (or ≥320 µm on Heidelberg Spectralis) in the study eye as determined by the reading center at the screening visit and confirmed by the site at baseline visit
* BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye at the screening and baseline visits with decreased vision determined to be primarily the result of DME
* Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention.
Exclusion Criteria
* Active proliferative diabetic retinopathy in the study eye
* Panretinal laser photocoagulation (PRP) or macular laser photocoagulation in the study eye within 12 weeks (84 days) of the screening visit
* IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, conbercept, faricimab, brolucizumab, pegaptanib sodium) in the study eye within 12 weeks (84 days) of the screening visit
* Previous use of topical steroids within 4 weeks (28 days) of the screening visit or of intraocular or periocular corticosteroids in the study eye within 16 weeks (112 days) of the screening visit, or ILUVIEN or OZURDEX IVT implants at any time
* Prior ocular investigational agents (that have not been approved) in either eye (e.g., IVT, suprachoroidal injections, ocular implants, etc.) at any time.
* Previous treatment with an investigational or approved intraocular gene therapy or cell therapy in either eye at any time.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Locations
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The Second Hospital of Anhui medical university
Hefei, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Guangdong Provincial Hospital of TCM
Guangzhou, Guangdong, China
Guangzhou First People Hospital
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Luoyang Third People's Hospital
Luoyang, Henan, China
Renmin Hosp., Wuhan Univ.
Wuhan, Hubei, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Affiliated hospital of Nantong university
Nantong, Jiangsu, China
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Hospital of Jilin University
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
Aier Eye Hospital (LIAONING)
Shenyang, Liaoning, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Sichuan University West China Hospital
Chengdu, Sichuan, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Zhengzhou Second People's Hospital
Erqi, Zhengzhou, China
Beijing Aier Intech Eye Hospital
Beijing, , China
Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Capital Medical University (CMU) - Beijing Tongren Hospital
Beijing, , China
Central South University - The Second Xiangya Hospital
Changsha, , China
Chengdu Aier Ophthalmology Hospital
Chengdu, , China
Chengdu University of Traditional Chinese Medicine - Teaching Hospital (Sichuan Province Traditional Chinese Medicine Hospital)
Chengdu, , China
The First Affiliated Hospital of Chongqing Medical Universit
Chongqing, , China
Guangzhou Aier Ophthalmology Hospital
Guangzhou, , China
Zhejiang University School of Medicine - The Second Affiliated Hospital
Hangzhou, , China
Hebei eye hospital
Hebei, , China
Henan Provincial Eye Hospital
Henan, , China
Jinan Second People's Hospital
Jinan, , China
Eye hospital of Shandong First Medical University
Jinan, , China
People's Hospital of Ningxia Hui Autonomous Region - Opthalmology
Ningxia, , China
Shandong University of Traditional Chinese Medicine Affiliated Ophthalmology Hospital
Shandong, , China
Weifang Ophthalmology Hospital
Shandong, , China
Shanghai eye disease prevention and control center
Shanghai, , China
Shanghai General Hospital
Shanghai, , China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - XinHua Hospital
Shanghai, , China
Eye & Ent Hospital of Fudan University
Shanghai, , China
Joint Shantou International Eye Center (JSIEC)Shantou University & the Chinese University of Hong Kong
Shantou, , China
Shanxi Eye Hospital
Shanxi, , China
Shenyang He Eye Specialist Hospital
Shenyang, , China
The Fourth People's Hospital of Shenyang
Shenyang, , China
Shijiazhuang People's Hospital
Shijiazhuang, , China
Tianjin Medical University Eye Hospital
Tianjin, , China
Eye Hospital of Wenzhou Medical University
Wenzhou, , China
Xi'an People's Hospital (Xi'an Fourth Hospital)
Xi'an, , China
Xianyang First People's Hospital
Xianyang, , China
Grantham Hospital
Hong Kong, , Hong Kong
Tseung Kwan O Hospital
Tseung Kwan O, , Hong Kong
Countries
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Related Links
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Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.
Other Identifiers
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21583
Identifier Type: -
Identifier Source: org_study_id
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