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Diabetic Macular Edema (DME)Phase 3NCT07515079

Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema

A Phase 3 study testing BAT5906 injection and Lucentis in people with Diabetic Macular Edema (DME), run by Bio-Thera Solutions at 50 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A multicenter, randomized, double-blind, parallel-group, active-controlled non-inferiority trial. A total of 406 subjects with diabetic macular edema (DME) were planned for enrollment. After screening, eligible subjects were randomized in a 1:1 ratio to the treatment group or the control group. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetic Macular Edema (DME)
What is being tested?
BAT5906 injection and Lucentis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
50 sitesChina
Study dates
9 Oct 2024to 30 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All of the following criteria must be met for inclusion:
  • Voluntarily signed informed consent form, willing and able to comply with outpatient visits and study procedures as scheduled by the trial.
  • Diagnosed with type 1 or type 2 diabetes, aged 18 to 80 years (including boundary values).
  • Diabetic macular edema (DME) with OCT findings demonstrating involvement of the macular center (fovea or paracentral fovea) in the study eye. (fovea or parafovea);
  • Central retinal thickness (CRT) of the study eye >300 μm (or >320 μm for Heidelberg OCT) as assessed by central image review during screening;
  • Best-corrected visual acuity (BCVA) of the study eye between 73 and 21 letters (using ETDRS chart, including boundary values; equivalent to Snellen visual acuity scores of 20/40 to 20/400);
  • Contralateral eye BCVA > 24 letters (using ETDRS chart, equivalent to Snellen acuity 20/320); Note: If both eyes meet inclusion criteria, the eye with poorer BCVA is selected as the study eye, unless the investigator determines the other eye is more suitable.

Who cannot join

  • Patients meeting any of the following criteria will be excluded from this study:
  • Presence of structural damage in the central macula of the study eye that may prevent improvement in best-corrected visual acuity after resolution of macular edema, including retinal pigment epithelial cell atrophy, subretinal fibrosis or scarring, significant macular ischemia (as indicated by marked disruption of the arcade pattern on fluorescein angiography), or histochemical sclerosing exudates. 2. Vitreomacular traction or epimacular membrane deemed by the investigator to significantly impair visual improvement;
  • Presence of any condition in the study eye other than diabetic macular edema that may confound fundus evaluation or visual acuity testing (e.g., retinal vascular occlusion, retinal detachment, optic nerve ischemia, vitreomacular traction, macular hole, pre-retinal fibrosis involving the macula, choroidal neovascularization, age-related macular degeneration);
  • Aphakia in the study eye or presence of an intraocular lens with posterior capsule opacification (exemption granted for posterior capsule opacification resulting from YAG capsulotomy, provided a 1-month washout period is met);
  • The study eye has uncontrolled glaucoma (intraocular pressure >25 mmHg despite antiglaucoma medication); or a history of glaucoma filtration surgery; or plans for antiglaucoma surgery during the study period;
  • The study eye has undergone vitreoretinal surgery or scleral buckling;
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  • The study eye has undergone panretinal photocoagulation (PRP) or focal/grid PRP in the macular area within the preceding 3 months, or there is a possibility of undergoing PRP during the study period;
  • Presence of neovascular glaucoma, iris neovascularization, or other clinically significant iris lesions deemed abnormal by the investigator in the study eye;
  • Active proliferative diabetic retinopathy (PDR) in the study eye, characterized by fibrovascular proliferation, vitreous hemorrhage, and retinal detachment;
  • The study eye has undergone intraocular surgery within the past 3 months, or is scheduled to undergo intraocular surgery during the study period;
  • The study eye has refractive media opacities (e.g., corneal scarring, undilatable pupils, cataracts, vitreous hemorrhage) that interfere with visual acuity assessment or fundus examination;
  • The study eye has received intravitreal injection of long-acting or sustained-release corticosteroids (e.g., dexamethasone intravitreal implant) or high-dose oral corticosteroids (>10 mg prednisolone or equivalent daily dose) within 6 months prior to baseline, except for patients using inhaled, intranasal, or low-dose topical corticosteroids applied to the skin; the study eye had received intravitreal injections of short- or medium-acting corticosteroids (e.g., triamcinolone) within 3 months prior to baseline; Periorbital corticosteroid injections administered to the study eye within 1 month prior to baseline; Fluocortolone intravitreal implants used in the study eye at any time prior to baseline; Systemic corticosteroid therapy received within 5 days prior to baseline;
  • The equivalent spherical refractive error of the study eye exceeds -6.0 diopters. For patients with a history of refractive or cataract surgery, the refractive error of the study eye should not exceed -6.0 diopters preoperatively. If preoperative refractive results are unavailable, the measured axial length must not exceed 26mm;
  • History of uveitis in either eye;
  • Active ocular inflammation or infection (bacterial, viral, parasitic, or fungal) in either eye;
  • Receipt of anti-VEGF therapy in the study eye or systemic administration within 90 days (inclusive) prior to randomization;
  • Abnormal liver or renal function (defined in this trial as ALT and AST not exceeding 2.5 times the upper limit of normal for this center's laboratory; Crea and BUN not exceeding 2 times the upper limit of normal for this center's laboratory);
  • Coagulation abnormalities (prothrombin time > 3 seconds above the upper limit of normal, activated partial thromboplastin time > 10 seconds above the upper limit of normal);
  • Patients with any active infection: positive hepatitis B screening (defined as positive hepatitis B surface antigen and HBV-DNA > 1000 IU/mL or the hospital's maximum cutoff value), Positive screening for hepatitis C (defined as positive HCV antibodies and positive HCV-RNA), positive human immunodeficiency virus (HIV) antibodies, positive screening for Treponema pallidum antibodies (Anti-TP) (positive specific antibody test, negative non-specific antibody test, except for those clinically assessed as non-active infection).
  • Other exclusion criteria:
  • Acute cardiovascular or cerebrovascular disease, related treatment, or other thromboembolic disorders within 6 months prior to first dosing;
  • Poorly controlled diabetes or glycated hemoglobin (HbA1c) >11%;
  • Uncontrolled hypertension (defined as blood pressure >160/95 mmHg despite antihypertensive medication);
  • Undergone surgery within the past month with unhealed wounds, or as determined by the investigator;
  • Diagnosed systemic autoimmune disease (e.g., ankylosing spondylitis, systemic lupus erythematosus) or any uncontrolled clinical condition (e.g., malignancy, active hepatitis, severe psychiatric, neurological, cardiovascular, respiratory disorders);
  • History of conditions contraindicated for the study drug, metabolic dysfunction, physical examination findings, or diseases/symptoms reasonably suspected based on clinical laboratory results that are contraindications for the study drug, may affect study outcome assessment, or expose the subject to a higher risk of complications;
  • Known allergy or contraindication to the study drug or its components, fluorescein, povidone-iodine, or indocyanine green;
  • Participation in any drug clinical trial (excluding vitamins and minerals) within 90 days prior to the first study dose (calculated from the last dose of the investigational drug; if the investigational drug has a long half-life, the period shall be 5 half-lives if >3 months);
  • Pregnant, pregnant women, or lactating women (pregnancy defined in this trial as a positive blood/urine pregnancy test); Male or female subjects of reproductive potential who refuse to use appropriate contraception (e.g., intrauterine device, oral contraceptives, condoms) throughout the study period and for 3 months after the last visit. Women defined as reproductive potential include those who have not yet reached menopause, or who have reached menopause but have not maintained a continuous menopausal state for >12 months, and who have not undergone sterilization (ovariectomy and/or hysterectomy). The definition of fertility may be adjusted according to local standards in each region.
  • Note: Highly effective contraceptive methods include complete abstinence, intrauterine devices, dual barrier methods (e.g., condom + spermicide-containing diaphragm), contraceptive implants, hormonal contraceptives [oral contraceptives, contraceptive implants, transdermal patches, hormonal vaginal devices, or depot injections], or a partner who has undergone vasectomy with confirmed azoospermia.
  • Other conditions deemed by the investigator to warrant exclusion.

Trial locations and contacts

50 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xizhen Hu contact

020-32203220

xzhu@bio-thera.com

Zhaohe Wang, Ph.D contact

50 sites in 1 country

China50 sites, 47 recruiting

  • Beijing Aier Yingzhi Eye Hospital

    Beijing, Beijing Municipality

    Wei Gu

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality

    Recruiting

  • Cangzhou Central Hospital

    Cangzhou, Hebei

    Zhixue Wang

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin

    Zhihua Cui

    Recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin

    Jun Xiao

    Recruiting

  • Changsha Aier Eye Hospital

    Changsha, Hunan

    Hongjie Ma

    Recruiting

  • Chengdu University of Traditional Chinese Medicine Affiliated Hospital

    Chengdu, Sichuan

    Yanlin Zheng

    Recruiting

  • Chengdu University of Traditional Chinese Medicine Yinhai Eye Hospital

    Chengdu, Sichuan

    Terminated

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Meixia Wang

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Hui Peng

    Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Xiyuan Zhou

    Recruiting

  • Deyang People's Hospital

    Deyang, Sichuan

    Wencheng Su

    Recruiting

  • Guangzhou Aier Eye Hospital

    Guangzhou, Guangdong

    Shibo Tang

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Hao Cheng

    Recruiting

  • The Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Binghong Wang

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

    Miaoqin Wu

    Recruiting

  • Zhejiang Xiaoshan Hospital

    Hangzhou, Zhejiang

    Xiaoyou Lu

    Recruiting

  • Jinan Second People's Hospital

    Jinan, Shandong

    Xiangwen Shu

    Recruiting

  • Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital

    Jinan, Shandong

    Xuemei Pan

    Recruiting

  • Gansu Provincial People's Hospital

    Lanzhou, Gansu

    Active, not recruiting

  • The Second Hospital of Lanzhou University

    Lanzhou, Gansu

    Wenfang Zhang

    Recruiting

  • Luoyang Third People's Hospital

    Luoyang, Henan

    Jingbo Li

    Recruiting

  • Nanjing Medical University Eye Hospital

    Nanjing, Jiangsu

    Terminated

  • Guangxi Zhuang Autonomous Region People's Hospital

    Nanning, Guangxi

    Ling Cui

    Recruiting

  • Inner Mongolia Medical University Affiliated Hospital

    Neimeng, Neimenggu

    Dan Zhu

    Recruiting

  • Panjin Liaoyang Gem Flower Hospital

    Panjin, Liaoning

    Jun Zhao

    Recruiting

  • Longhua Hospital Affiliated with Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality

    Xinquan Liu

    Recruiting

  • Shanghai Eye Disease Prevention and Treatment Center

    Shanghai, Shanghai Municipality

    Tao Sun

    Recruiting

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality

    Xiaodong Sun

    Recruiting

  • Shantou University-The Chinese University of Hong Kong Joint Shantou International Eye Center

    Shantou, Guangdong

    Haoyu Chen

    Recruiting

  • Shenyang Fourth People's Hospital

    Shenyang, Liaoning

    Li Xu

    Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

    Mingming Yang

    Recruiting

  • Shijiazhuang Municipal People's Hospital

    Shijiazhuang, Hebei

    Qian Ren

    Recruiting

  • Shanxi Provincial Eye Hospital

    Taiyuan, Shanxi

    Yanyun Shi

    Recruiting

  • Taizhou Hospital, Zhejiang Province

    Taizhou, Zhejiang

    Gangfeng Cui

    Recruiting

  • Weifang Eye Hospital

    Weifang, Shandong

    Xinyan Xu

    Recruiting

  • Weifang Medical University Affiliated Hospital

    Weifang, Shandong

    Aijun Deng

    Recruiting

  • Wenzhou Medical University Eye Hospital

    Wenzhou, Zhejiang

    Zuhua Sun

    Recruiting

  • Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

    Pengcheng Li

    Recruiting

  • Wuhan Central Hospital

    Wuhan, Hubei

    Shuang Li

    Recruiting

  • Wuhan Puren Hospital

    Wuhan, Hubei

    Jianjun Peng

    Recruiting

  • Wuhan University People's Hospital (Hubei Provincial People's Hospital)

    Wuhan, Hubei

    Xuan Xiao

    Recruiting

  • Wuxi Municipal People's Hospital

    Wuxi, Jiangsu

    Yong Yao

    Recruiting

  • Xi'an First Hospital

    Xi’an, Shanxi

    Huiqin Lu

    Recruiting

  • Xi'an Fourth Hospital

    Xi’an, Shanxi

    Chunling Lei

    Recruiting

  • Xianyang First People's Hospital

    Xianyang, Shanxi

    Yongxiao Dong

    Recruiting

  • Hebei Eye Hospital

    Xingtai, Hebei

    Wei Wang

    Recruiting

  • Henan Eye Center (Henan Provincial Eye Hospital)

    Zhengzhou, Henan

    Zongming Song

    Recruiting

  • Zhengzhou Second People's Hospital

    Zhengzhou, Henan

    Xuexia Gao

    Recruiting

  • Zunyi Medical University Affiliated Hospital

    Zunyi, Guizhou

    Hong Li

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind Phase III Clinical Study Comparing the Efficacy and Safety of BAT5906 Versus Ranibizumab (Lucentis®) in Patients With Diabetic Macular Edema (DME)

A multicenter, randomized, double-blind, parallel-group, active-controlled non-inferiority trial. A total of 406 subjects with diabetic macular edema (DME) were planned for enrollment. After screening, eligible subjects were randomized in a 1:1 ratio to the treatment group or the control group. The treatment group received BAT5906 injection, while the control group received Lucentis®. During the trial, ophthalmic examinations and safety assessments were conducted according to the protocol for efficacy and safety evaluation. Blood samples were collected for immunogenicity assessment. The primary endpoint was the mean change in best-corrected visual acuity (BCVA) in the study eye from baseline to week 52 (measured using the ETDRS chart).

Being tested
BAT5906 injection, Lucentis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAT5906 injectionDrug

    4.0 mg/eye/time, 50 μl, intravitreal injection

  • LucentisDrug

    0.5 mg/eye/time, 50 μl, intravitreal injection

Study groups in NCT07515079
Study groupRoleWhat they receive
Experimental group：BAT5906ExperimentalIntravitreal injection; Dose: 4.0 mg per eye per injection, 50 μl; Treatment schedule: Administered once every 4 weeks for 3 consecutive doses, followed by monitoring every 4 weeks thereafter (with on-demand dosing at investigator discretion), continuing through Week 52.
Receives: Drug: BAT5906 injection
Control group：Lucentis®Active comparatorIntravitreal injection; Dose: 0.5 mg per eye per injection, 50 μl; Treatment schedule: Administered once every 4 weeks for 3 consecutive doses, followed by follow-up visits every 4 weeks thereafter (with on-demand dosing as determined by the investigator), continuing through Week 52.
Receives: Drug: Lucentis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change in the BCVA value

    Compared to baseline, two groups of subjects studied the value of changes in ocular 52nd week BCVA

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study start9 Oct 2024
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
406 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07515079
Sponsor's protocol ID
BAT5906-005-CR
Status last verified
Mar 2026
First submitted
23 Mar 2026
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BAT5906 injection and Lucentis in people with Diabetic Macular Edema (DME), run by Bio-Thera Solutions at 50 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xizhen Hu (020-32203220, xzhu@bio-thera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in the BCVA value (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07515079.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

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