New hope for diabetes-related vision loss: experimental drug faces final test

NCT ID NCT07515079

Disease control Sponsor: Bio-Thera Solutions Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new eye medication called BAT5906 against an approved drug (Lucentis) for people with diabetic macular edema, a condition that causes vision loss in diabetes. About 406 adults with type 1 or type 2 diabetes will receive injections into the eye and be followed for a year. The main goal is to see if BAT5906 improves vision as well as the standard treatment.

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

About 406 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

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 to 80 years

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.

Inclusion Criteria: * All of the following criteria must be met for inclusion: 1. Voluntarily signed informed consent form, willing and able to comply with outpatient visits and study procedures as scheduled by the trial. 2. Diagnosed with type 1 or type 2 diabetes, aged 18 to 80 years (including boundary values). 3. Diabetic macular edema (DME) with OCT findings demonstrating involvement of the macular center (fovea or paracentral fovea) in the study eye. (fovea or parafovea); 4. Central retinal thickness (CRT) of the study eye \>300 μm (or \>320 μm for Heidelberg OCT) as assessed by central image review during screening; 5. 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); 6. 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. Exclusion Criteria: * Patients meeting any of the following criteria will be excluded from this study: 1. 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; 2. 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); 3. 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); 4. 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; 5. The study eye has undergone vitreoretinal surgery or scleral buckling; 6. 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; 7. Presence of neovascular glaucoma, iris neovascularization, or other clinically significant iris lesions deemed abnormal by the investigator in the study eye; 8. Active proliferative diabetic retinopathy (PDR) in the study eye, characterized by fibrovascular proliferation, vitreous hemorrhage, and retinal detachment; 9. The study eye has undergone intraocular surgery within the past 3 months, or is scheduled to undergo intraocular surgery during the study period; 10. 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; 11. 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; 12. 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; 13. History of uveitis in either eye; 14. Active ocular inflammation or infection (bacterial, viral, parasitic, or fungal) in either eye; 15. Receipt of anti-VEGF therapy in the study eye or systemic administration within 90 days (inclusive) prior to randomization; Exclusion Criteria for Abnormal Laboratory Findings: 16. 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); 17. Coagulation abnormalities (prothrombin time \> 3 seconds above the upper limit of normal, activated partial thromboplastin time \> 10 seconds above the upper limit of normal); 18. 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: 19. Acute cardiovascular or cerebrovascular disease, related treatment, or other thromboembolic disorders within 6 months prior to first dosing; 20. Poorly controlled diabetes or glycated hemoglobin (HbA1c) \>11%; 21. Uncontrolled hypertension (defined as blood pressure \>160/95 mmHg despite antihypertensive medication); 22. Undergone surgery within the past month with unhealed wounds, or as determined by the investigator; 23. 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); 24. 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; 25. Known allergy or contraindication to the study drug or its components, fluorescein, povidone-iodine, or indocyanine green; 26. 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); 27. 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. 28. Other conditions deemed by the investigator to warrant exclusion.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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 (DME)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

47 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Beijing Aier Yingzhi Eye Hospital
RECRUITING

Beijing, Beijing Municipality, China
Cangzhou Central Hospital
RECRUITING

Cangzhou, Hebei, China
Changsha Aier Eye Hospital
RECRUITING

Changsha, Hunan, China
Chengdu University of Traditional Chinese Medicine Affiliated Hospital
RECRUITING

Chengdu, Sichuan, China
Chengdu University of Traditional Chinese Medicine Yinhai Eye Hospital
TERMINATED

Chengdu, Sichuan, China
Deyang People's Hospital
RECRUITING

Deyang, Sichuan, China
Gansu Provincial People's Hospital
ACTIVE_NOT_RECRUITING

Lanzhou, Gansu, China
Guangxi Zhuang Autonomous Region People's Hospital
RECRUITING

Nanning, Guangxi, China
Guangzhou Aier Eye Hospital
RECRUITING

Guangzhou, Guangdong, China
Hebei Eye Hospital
RECRUITING

Xingtai, Hebei, China
Henan Eye Center (Henan Provincial Eye Hospital)
RECRUITING

Zhengzhou, Henan, China
Inner Mongolia Medical University Affiliated Hospital
RECRUITING

Neimeng, Neimenggu, China
Jinan Second People's Hospital
RECRUITING

Jinan, Shandong, China
Longhua Hospital Affiliated with Shanghai University of Traditional Chinese Medicine
RECRUITING

Shanghai, Shanghai Municipality, China
Luoyang Third People's Hospital
RECRUITING

Luoyang, Henan, China
Nanjing Medical University Eye Hospital
TERMINATED

Nanjing, Jiangsu, China
Panjin Liaoyang Gem Flower Hospital
RECRUITING

Panjin, Liaoning, China
Peking University Third Hospital
RECRUITING

Beijing, Beijing Municipality, China
Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
RECRUITING

Jinan, Shandong, China
Shanghai Eye Disease Prevention and Treatment Center
RECRUITING

Shanghai, Shanghai Municipality, China
Shanghai First People's Hospital
RECRUITING

Shanghai, Shanghai Municipality, China
Shantou University-The Chinese University of Hong Kong Joint Shantou International Eye Center
RECRUITING

Shantou, Guangdong, China
Shanxi Provincial Eye Hospital
RECRUITING

Taiyuan, Shanxi, China
Shenyang Fourth People's Hospital
RECRUITING

Shenyang, Liaoning, China
Shenzhen People's Hospital
RECRUITING

Shenzhen, Guangdong, China
Shijiazhuang Municipal People's Hospital
RECRUITING

Shijiazhuang, Hebei, China
Taizhou Hospital, Zhejiang Province
RECRUITING

Taizhou, Zhejiang, China
The First Affiliated Hospital of Chongqing Medical University
RECRUITING

Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING

Guangzhou, Guangdong, China
The First Hospital of Jilin University
RECRUITING

Changchun, Jilin, China
The Second Affiliated Hospital of Chongqing Medical University
RECRUITING

Chongqing, Chongqing Municipality, China
The Second Hospital of Jilin University
RECRUITING

Changchun, Jilin, China
The Second Hospital of Lanzhou University
RECRUITING

Lanzhou, Gansu, China
The Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
RECRUITING

Hangzhou, Zhejiang, China
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
RECRUITING

Wuhan, Hubei, China
Weifang Eye Hospital
RECRUITING

Weifang, Shandong, China
Weifang Medical University Affiliated Hospital
RECRUITING

Weifang, Shandong, China
Wenzhou Medical University Eye Hospital
RECRUITING

Wenzhou, Zhejiang, China
West China Hospital of Sichuan University
RECRUITING

Chengdu, Sichuan, China
Wuhan Central Hospital
RECRUITING

Wuhan, Hubei, China
Wuhan Puren Hospital
RECRUITING

Wuhan, Hubei, China
Wuhan University People's Hospital (Hubei Provincial People's Hospital)
RECRUITING

Wuhan, Hubei, China
Wuxi Municipal People's Hospital
RECRUITING

Wuxi, Jiangsu, China
Xi'an First Hospital
RECRUITING

Xi’an, Shanxi, China
Xi'an Fourth Hospital
RECRUITING

Xi’an, Shanxi, China
Xianyang First People's Hospital
RECRUITING

Xianyang, Shanxi, China
Zhejiang Provincial People's Hospital
RECRUITING

Hangzhou, Zhejiang, China
Zhejiang Xiaoshan Hospital
RECRUITING

Hangzhou, Zhejiang, China
Zhengzhou Second People's Hospital
RECRUITING

Zhengzhou, Henan, China
Zunyi Medical University Affiliated Hospital
RECRUITING

Zunyi, Guizhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.