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Fewer eye injections possible? new study tests Higher-Dose aflibercept for DME

NCT ID NCT06422507

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a higher dose (8 mg) of the drug aflibercept, given every 16 weeks, works as well as the standard dose (2 mg) given every 8 weeks for Chinese people with diabetic macular edema (DME), a diabetes-related eye condition that causes vision problems. 333 participants received either the high-dose or standard-dose injections into the eye. The main goal was to compare changes in vision after 48 weeks. If the higher dose works, it could mean fewer injections and less frequent doctor visits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aflibercept (8 mg and 2 mg doses)
What this could lead to
If successful, this could mean fewer eye injections for people with diabetic macular edema, making treatment easier and less burdensome.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The higher dose may not be as effective or safe as the lower dose, and findings in Chinese participants may not apply to other populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

333 people

The number who actually took part.

Started

May 2024

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Men or women ≥18 years of age * 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. Key Exclusion Criteria: * Evidence of macular edema due to any cause other than diabetes mellitus in either eye * 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.

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema

Contacts and locations

Locations

  • Affiliated hospital of Nantong university

    Nantong, Jiangsu, 226006, China

  • Aier Eye Hospital (LIAONING)

    Shenyang, Liaoning, China

  • Beijing Aier Intech Eye Hospital

    Beijing, 100000, China

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, 100050, China

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730, China

  • Capital Medical University (CMU) - Beijing Tongren Hospital

    Beijing, 100062, China

  • Central South University - The Second Xiangya Hospital

    Changsha, 410007, China

  • Chengdu Aier Ophthalmology Hospital

    Chengdu, 610041, China

  • Chengdu University of Traditional Chinese Medicine - Teaching Hospital (Sichuan Province Traditional Chinese Medicine Hospital)

    Chengdu, 610072, China

  • Eye & Ent Hospital of Fudan University

    Shanghai, 200126, China

  • Eye Hospital of Wenzhou Medical University

    Wenzhou, 325027, China

  • Eye hospital of Shandong First Medical University

    Jinan, 250299, China

  • Grantham Hospital

    Hong Kong, Hong Kong SAR, 00000, Hong Kong

  • Guangdong Provincial Hospital of TCM

    Guangzhou, Guangdong, 510120, China

  • Guangzhou Aier Ophthalmology Hospital

    Guangzhou, 510288, China

  • Guangzhou First People Hospital

    Guangzhou, Guangdong, 510180, China

  • Hebei eye hospital

    Hebei, 050010, China

  • Henan Provincial Eye Hospital

    Henan, 450008, China

  • Jinan Second People's Hospital

    Jinan, 250021, China

  • Joint Shantou International Eye Center (JSIEC)Shantou University & the Chinese University of Hong Kong

    Shantou, 515041, China

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030, China

  • Luoyang Third People's Hospital

    Luoyang, Henan, 471002, China

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006, China

  • People's Hospital of Ningxia Hui Autonomous Region - Opthalmology

    Ningxia, 750002, China

  • Renmin Hosp., Wuhan Univ.

    Wuhan, Hubei, 430040, China

  • Shandong University of Traditional Chinese Medicine Affiliated Ophthalmology Hospital

    Shandong, 250299, China

  • Shanghai General Hospital

    Shanghai, 200080, China

  • Shanghai Jiao Tong University School of Medicine (SJTUSM) - XinHua Hospital

    Shanghai, 200092, China

  • Shanghai eye disease prevention and control center

    Shanghai, 200041, China

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032, China

  • Shanxi Eye Hospital

    Shanxi, 030002, China

  • Shenyang He Eye Specialist Hospital

    Shenyang, 110034, China

  • Shijiazhuang People's Hospital

    Shijiazhuang, 050011, China

  • Sichuan University West China Hospital

    Chengdu, Sichuan, MISSING, China

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317099, China

  • The First Affiliated Hospital of Chongqing Medical Universit

    Chongqing, 400042, China

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001, China

  • The First Affiliated Hospital of NanChang University

    Nanchang, Jiangxi, 330006, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130061, China

  • The Fourth People's Hospital of Shenyang

    Shenyang, 110082, China

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330200, China

  • The Second Hospital of Anhui medical university

    Hefei, Anhui, 230601, China

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130000, China

  • Tianjin Medical University Eye Hospital

    Tianjin, 300384, China

  • Tseung Kwan O Hospital

    Tseung Kwan O, New Territories, 00000, Hong Kong

  • Weifang Ophthalmology Hospital

    Shandong, 261041, China

  • Xi'an People's Hospital (Xi'an Fourth Hospital)

    Xi'an, 710005, China

  • Xianyang First People's Hospital

    Xianyang, 712099, China

  • Zhejiang University School of Medicine - The Second Affiliated Hospital

    Hangzhou, 310003, China

  • Zhengzhou Second People's Hospital

    Erqi, Zhengzhou, 450015, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280, China

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