New eye drug shows promise in battle against blinding disease

NCT ID NCT05439629

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

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

Summary

This study tested a new medicine called BAT5906 against a standard treatment (Lucentis) for wet age-related macular degeneration, a condition that can cause rapid vision loss. 488 adults aged 50-85 with active disease received either BAT5906 or Lucentis injections into the eye. The goal was to see if BAT5906 works as well as Lucentis at improving or maintaining eyesight over 52 weeks.

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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

488 people

The number who actually took part.

Started

Jul 2022

Finished

Apr 2025

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

50 to 85 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: 1. Understand and sign the informed consent, and be willing to follow up according to the time specified in the trial; 2. Age 50-85 years old (including boundary value), male and female; 3. Study the subjects who were diagnosed with neovascular age-related macular degeneration and still had active lesions confirmed by imaging examination. Active lesions were defined as the presence of any of the following lesions in the macular area: ① intraretinal fluid; ② Lipid exudation in the retina; ③ Subretinal fluid; (4) Subretinal hemorrhage; (5) Retinal pigment epithelium detachment; ⑥ Choroidal neovascularization leakage; 4. The total area of the study eye lesions ≤30mm2(12 optic disc areas) was confirmed by the film reading center before randomization; 5. The BCVA of the study eye at screening and baseline was 73-19 letters (ETDRS visual acuity chart, including boundary values), equivalent to Snellen visual acuity 20/40 to 20/400; 6. BCVA≥19 letters, equivalent to Snellen visual acuity ≥20/400, measured by ETDRS visual chart at screening and baseline in non-study eyes. Exclusion Criteria: 1. The study eyes received any intravitreal anti-VEGF therapy (such as bevacizumab, abbercept, ranibizumab, conbercept, etc.) within 3 months before randomization; 2. The study eyes had received the following treatments within 3 months before randomization: verteporfin photodynamic therapy (PDT), macular laser photocoagulation, transpillary thermotherapy (TTT), and other surgeries for AMD; 3. The study eyes had undergone the following ophthalmic surgeries: vitrectomy, anti-glaucoma surgery, and macular transposition. The study eyes had undergone internal eye surgery (including cataract surgery) within 3 months before randomization, or external eye surgery within 1 month before randomization; 4. The study eyes received intravitreal injection treatment (such as triamcinolone acetonide and dexamethasone) within 3 months before randomization, intravitreal injection of dexamethasone sustained release within 6 months, and injection of long-acting corticosteroids (such as triamcinolone acetonide, etc.) within, periocular or subconjunctival injection of any eye 3 months before randomization; 5. Study eyes with ocular diseases affecting central vision (such as diabetic retinopathy, retinal vein occlusion, uveitis, vascular striation, pathological myopia, retinal detachment, macular hole, macular epiretinal membrane, toxoplasmosis, optic nerve diseases); 6. Study eyes with foveal ground pattern atrophy, scar or fibrosis, dense subfoveal hard exudation, retinal pigment epithelium (RPE) tear involving the center of the macula (confirmed by the reading center during screening); 7. The study eyes had choroidal neovascularization not caused by nAMD, progressive retinopathy affecting corrected visual acuity, and any eye had vitreous hemorrhage or a history of vitreous hemorrhage, or a history of retinal detachment; 8. The equivalent spherical mirror of the study eye with refractive error showed more than -6.0 diopters. For patients with previous refractive surgery or cataract surgery, the preoperative refractive error of the study eye should not exceed -6.0 diopters; 9. The study eyes were lens free (excluding IOL eyes) or posterior lens capsule rupture (except YAG laser posterior capsuleotomy after IOL implantation more than 1 month before screening); 10. The study eye has obvious refractive interstitial opacity or pupil failure, including cataract and corneal opacity, which may interfere with visual acuity assessment, safety assessment or fundus photography; 11. The study eyes had pupil afferent defect (APD); 12. Study eyes had uncontrolled glaucoma at randomization, defined as intraocular pressure that remained higher than 25mmHg after medical treatment or as judged by the investigator; 13. Non-study eyes received photodynamic therapy (PDT) within 1 month before randomization; 14. History of idiopathic or autoimmune associated uveitis in any eye; 15. Pseudocyst stripping syndrome in any eye; 16. Active eye infection in any eye (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, iridecocyclitis, endophthalmitis); 17. Systemic drugs that cause crystal or retinal toxicity, such as deferoxamine, chloroquine/hydroxychloroquine, phenothiazine and ethambutol or tamoxifen, are currently being used or may be required; 18. Allergic reaction or history to sodium fluorescein and indocyanine green, allergic history to protein products for therapeutic or diagnostic use, or known allergic reaction to any monoclonal antibody; 19. Patients who had surgery within 1 month before randomization and the surgery did not heal, and the investigator judged that the study drug had an effect on healing; 20. Presence of clinically significant active systemic infectious disease under treatment; 21. History of myocardial infarction, unstable angina, coronary revascularization, cerebrovascular accident (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, pulmonary embolism, deep vein thrombosis, portal vein thrombosis, etc.), New York Heart Association (NYHA) grade ≥II cardiac dysfunction within 6 months before randomization, Severe unstable ventricular arrhythmias; 22. Patients with active disseminated intravascular coagulation and significant bleeding tendency (such as hemoptysis, hematemesis, severe purpura, etc.) within 3 months before randomization, or who had received anticoagulant and antiplatelet therapy other than aspirin /NSAIDs within 14 days before screening; 23. Poorly controlled hypertension before randomization (defined as sitting systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg after antihypertensive medication); 24. Any uncontrollable clinical problems (such as serious mental, neurological, cardiovascular, respiratory and other system diseases and malignant tumors); 25. Abnormal liver and kidney function (ALT and AST should not be higher than 2.5 times of the upper limit of normal value in the central laboratory; Crea and BUN shall not be higher than 2 times of the upper limit of normal value in the central laboratory); 26. Abnormal coagulation function (prothrombin time \> upper limit of normal 3 seconds or activated partial thromboplastin time \> upper limit of normal 10 seconds); 27. Patients with any of the following infections: active hepatitis B (HBV DNA \> 1000 IU/mL if HBsAg(+)), hepatitis C, AIDS, or syphilis (syphilis RPR confirmatory test positive); 28. Planned parenthood during pregnancy or lactation, or during the study period and within 6 months after the study. The pregnancy test of fertile female patients was positive during the screening period; 29. Subjects who have participated in any drug (excluding vitamins and minerals) in the clinical trial within 3 months before randomization and have been treated with the experimental drug or device; 30. The researcher believes that it is not suitable for this study.

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Conditions

The condition(s) this trial relates to.

macular degeneration wet macular degeneration

As listed by the trial registrant

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

Neovascular (WET) age-related macular degeneration

Contacts and locations

Locations

Affiliated Hospital of Guizhou Medical University

Guiyang, China
Affiliated Hospital of Inner Mongolia Medical University

Beijing, China
Affiliated Hospital of Nantong University

Nantong, China
Beijing Chao Yang Hospital

Beijing, China
Beijing Hospital

Beijing, China
China-Japan Friendship Hospital

Beijing, China
First Affiliated Hospital of Fujian Medical University

Fujian, China
First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, China
Guangzhou Aier Eye Hospital

Guangzhou, China
Hebei Provincial Eye Hospital

Xingtai, China
Henan Eye Center (Henan Eye Hospital)

Zhengzhou, China
Huashan Hospital

Shanghai, China
Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjing, China
Jinan Second People's Hospital

Jinan, China
Jinzhong First People's Hospital

Jinzhong, China
Luoyang Third People's Hospital

Luoyang, China
Ningbo Eye Hospital

Ningbo, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China
Peking University People's Hospital

Beijing, China
People's Hospital of Quzhou

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

Hubei, China
Pingxiang People's Hospital

Pingxiang, China
Second Hospital of Shanxi Medical University

Taiyuan, China
Shanghai Oriental Hospital

Shanghai, China
Shanghai University of Traditional Chinese Medicine

Shanghai, China
Shantou University-Chinese University of Hong Kong Joint Shantou International Eye Centre

Shantou, China
Shenzhen People's Hospital

Shenzhen, China
Sun Yat-sen Ophthalmic Center, Sun Yat-sen University

Guangzhou, China
Taizhou Hospital of Zhejiang Province

Taizhou, China
The Affiliated Eye Hospital of Nanchang University

Nanchang, China
The Affiliated Eye Hospital of Shandong University of Chinese Medicine

Jinan, China
The First Affiliated Hospital of Army Medical University (Southwest Hospital)

Chongqing, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Guangzhou, China
The First Hospital of Jilin University

Jilin City, China
The First People's Hospital of Kunming

Kunming, China
The Fourth People's Hospital of Shenyang

Shenyang, China
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China
The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China
The Second Hospital of Anhui Medical University

Hefei, China
The Second People's Hospital of Zhengzhou

Zhengzhou, China
Weifang Eye Hospital

Weifang, China
Wenzhou Medical University Affiliated Optometry Hospital

Wenzhou, China
Xiangya Hospital of Central South University

Changsha, China
Xuzhou Central Hospital

Xuzhou, China
Yantai Yuhuangding Hospital

Yantai, China
Zhejiang Provincial People's Hospital

Hangzhou, China
Zunyi Medical College

Zunyi, China

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