Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Macular Degeneration
NCT ID: NCT05439629
Last Updated: 2025-12-08
Study Results
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Basic Information
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COMPLETED
PHASE3
488 participants
INTERVENTIONAL
2022-07-07
2025-04-22
Brief Summary
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Detailed Description
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The administration regimen was as follows: once every 4 weeks, 4mg BAT5906 or 0.5mg Lucentis® were injected intravitreal each time, the treatment period of the study was 48 weeks, a total of 13 administration times, the last follow-up was conducted at the 52nd week, the last visit did not require treatment, only efficacy and safety assessment, and blood samples were collected as required.
Ophthalmic examination, vital signs, physical examination, and laboratory examination were performed for efficacy and safety assessment according to the test procedures specified in the protocol, and blood samples were collected for immunogenicity indicators. Change in best corrected visual acuity (BCVA) from baseline was assessed by ETDRS visual acuity chart at 4-week intervals. The primary efficacy measure was the change in BCVA from baseline at 52 weeks. Secondary efficacy measures were the change in best corrected visual acuity (BCVA) of the target eye from baseline and the change in macular fovea thickness (CRT) from baseline at weeks 12, 24, 36 and 48.
Blood samples were collected according to the time points specified in the program, and the serum anti-drug antibody (ADA) was detected. Titer analysis and neutralizing antibody (Nab) analysis were performed on the samples confirmed as positive by ADA.
A non-inferiority design was used to conduct a randomized, double-blind, parallel-controlled multi-center study. A total of 488 subjects with neovascular (wet) age-related macular degeneration (w-AMD) were planned to be enrolled. Qualified subjects were divided into experimental group and control group in a 1:1 ratio, and stratified randomized according to the letter value of baseline period and whether the eyes had received anti-VEGF drug treatment. The experimental group received BAT5906 injection. The control group received Lucentis® treatment. Only 1 eye per subject was included in this study.
The administration regimen was as follows: once every 4 weeks, 4mg BAT5906 or 0.5mg Lucentis® were injected intravitreal each time, the treatment period of the study was 48 weeks, a total of 13 administration times, the last follow-up was conducted at the 52nd week, the last visit did not require treatment, only efficacy and safety assessment, and blood samples were collected as required.
Ophthalmic examination, vital signs, physical examination, and laboratory examination were performed for efficacy and safety assessment according to the test procedures specified in the protocol, and blood samples were collected for immunogenicity indicators. Change in best corrected visual acuity (BCVA) from baseline was assessed by ETDRS visual acuity chart at 4-week intervals. The primary efficacy measure was the change in BCVA from baseline at 52 weeks. Secondary efficacy measures were the change in best corrected visual acuity (BCVA) of the target eye from baseline and the change in macular fovea thickness (CRT) from baseline at weeks 12, 24, 36 and 48.
Blood samples were collected according to the time points specified in the program, and the serum anti-drug antibody (ADA) was detected. Titer analysis and neutralizing antibody (Nab) analysis were performed on the samples confirmed as positive by ADA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental group：BAT5906
Intravitreal injection; Dosage: 4.0 mg / eye / time, 50 μl; Duration of administration: every 4 weeks, administered to week 48, not administered at 52 weeks.
BAT5906 injection
4.0 mg/eye/time, 50 μl, intravitreal injection
Control group：Lucentis®
Intravitreal injection; Dosage: 0.5 mg / eye / time, 50 μl; Duration of administration: every 4 weeks, administered to week 48, not administered at 52 weeks.
Lucentis
0.5 mg/eye/time, 50 μl, intravitreal injection
Interventions
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BAT5906 injection
4.0 mg/eye/time, 50 μl, intravitreal injection
Lucentis
0.5 mg/eye/time, 50 μl, intravitreal injection
Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
85 Years
ALL
No
Sponsors
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Bio-Thera Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Youxin Chen, Doctor
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College
Xiaolin Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Affiliated Optometry Hospital of Wenzhou Medical University
Mingwei Zhao, Doctor
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Yi Chen, Doctor
Role: PRINCIPAL_INVESTIGATOR
China-Japan Friendship Hospital
Hong Dai, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Hospital
Yong Tao, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Chao Yang Hospital
Linna Lu, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Hongping Cui, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Oriental Hospital
Xiaolin Liang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen Ophthalmic Center, Sun Yat-sen University
Pengxia Wan, Doctor
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Yuqing Lan, Doctor
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Haoyu Chen, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shantou University-Chinese University of Hong Kong Joint Shantou International Eye Centre
Xiyuan Zhou, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Chongqing Medical University
Xiaohong Meng, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Jinglin Yi, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Eye Hospital of Nanchang University
Hongmei Zheng, Doctor
Role: PRINCIPAL_INVESTIGATOR
People's Hospital of Wuhan University (Hubei Provincial People's Hospital)
Liuhua Tong, Doctor
Role: PRINCIPAL_INVESTIGATOR
People's Hospital of Quzhou
Zongming Song, Doctor
Role: PRINCIPAL_INVESTIGATOR
Henan Eye Center (Henan Eye Hospital)
Shenzhi Liang, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Junfeng Mao, Doctor
Role: PRINCIPAL_INVESTIGATOR
Xiangya Hospital of Central South University
Xiangwen Shu, Master
Role: PRINCIPAL_INVESTIGATOR
Jinan Second People's Hospital
Yuanbin Li, Doctor
Role: PRINCIPAL_INVESTIGATOR
Yantai Yuhuangding Hospital
Shanjun Cai, Doctor
Role: PRINCIPAL_INVESTIGATOR
Zunyi Medical College
Xian Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Guizhou Medical University
Xu Li, Master
Role: PRINCIPAL_INVESTIGATOR
The Fourth People's Hospital of Shenyang
Rongrong Zhu, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Nantong University
Wei Wei, Doctor
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Yabin Sun, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Liming Tao, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Second Hospital of Anhui Medical University
Hongjian Ma, Doctor
Role: PRINCIPAL_INVESTIGATOR
Aier Eye Hospital, Guangzhou
Yaohong Wu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Second Hospital of Shanxi Medical University
Jian Guo, Doctor
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Fujian Medical University
Xiaoling Luo, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shenzhen People's Hospital
Qiuhong Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Xinquan Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai University of Traditional Chinese Medicine
Lifei Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hebei Provincial Eye Hospital
Dan Zhu, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Inner Mongolia Medical University
Xuemei Pan, Master
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Eye Hospital of Shandong University of Chinese Medicine
Yanfei Qiu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Pingxiang People's Hospital
Zhen Zhang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Xuzhou Central Hospital
Jingbo Li, Doctor
Role: PRINCIPAL_INVESTIGATOR
Luoyang Third People's Hospital
Xinyan Xu, Master
Role: PRINCIPAL_INVESTIGATOR
Weifang Eye Hospital
Lan Li, Master
Role: PRINCIPAL_INVESTIGATOR
The First People's Hospital of Kunming
Hongxia Yang, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Jinzhong First People's Hospital
Miaoqin Wu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Provincial People's Hospital
Zhaozeng Lu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Gangfeng Cui, Doctor
Role: PRINCIPAL_INVESTIGATOR
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Quanyong Yi, Doctor
Role: PRINCIPAL_INVESTIGATOR
Ningbo Eye Hospital
Ruifeng Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Second People's Hospital of Zhengzhou
Locations
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Affiliated Hospital of Inner Mongolia Medical University
Beijing, , China
Beijing Chao Yang Hospital
Beijing, , China
Beijing Hospital
Beijing, , China
China-Japan Friendship Hospital
Beijing, , China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Peking University People's Hospital
Beijing, , China
Xiangya Hospital of Central South University
Changsha, , China
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Chongqing, , China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, , 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
Sun Yat-sen Ophthalmic Center, Sun Yat-sen University
Guangzhou, , China
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Guangzhou, , China
Affiliated Hospital of Guizhou Medical University
Guiyang, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
The Second Hospital of Anhui Medical University
Hefei, , China
People's Hospital of Wuhan University (Hubei Provincial People's Hospital)
Hubei, , China
The First Hospital of Jilin University
Jilin, , China
Jinan Second People's Hospital
Jinan, , China
The Affiliated Eye Hospital of Shandong University of Chinese Medicine
Jinan, , China
Jinzhong First People's Hospital
Jinzhong, , China
The First People's Hospital of Kunming
Kunming, , China
Luoyang Third People's Hospital
Luoyang, , China
The Affiliated Eye Hospital of Nanchang University
Nanchang, , China
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, , China
Affiliated Hospital of Nantong University
Nantong, , China
Ningbo Eye Hospital
Ningbo, , China
Pingxiang People's Hospital
Pingxiang, , China
People's Hospital of Quzhou
Quzhou, , China
Huashan Hospital
Shanghai, , China
Shanghai Oriental Hospital
Shanghai, , China
Shanghai University of Traditional Chinese Medicine
Shanghai, , China
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Shantou University-Chinese University of Hong Kong Joint Shantou International Eye Centre
Shantou, , China
The Fourth People's Hospital of Shenyang
Shenyang, , China
Shenzhen People's Hospital
Shenzhen, , China
Second Hospital of Shanxi Medical University
Taiyuan, , China
Taizhou Hospital of Zhejiang Province
Taizhou, , China
Weifang Eye Hospital
Weifang, , China
Wenzhou Medical University Affiliated Optometry Hospital
Wenzhou, , China
Hebei Provincial Eye Hospital
Xingtai, , China
Xuzhou Central Hospital
Xuzhou, , China
Yantai Yuhuangding Hospital
Yantai, , China
Henan Eye Center (Henan Eye Hospital)
Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
The Second People's Hospital of Zhengzhou
Zhengzhou, , China
Zunyi Medical College
Zunyi, , China
Countries
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Other Identifiers
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BAT5906-004-CR
Identifier Type: -
Identifier Source: org_study_id
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