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

NCT05439629 | Completed Phase 3

• 1 other identifier: BAT5906-004-CR
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 48

Brief Summary

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.

Conditions

Neovascular (Wet) Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (5)

• The change in the BCVA value

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

  Week 52

• The change in the BCVA value

  Compared to baseline, two groups of subjects studied the changes in bcVA at weeks 12, 24, 36, and 48 of the eye

  at weeks 12, 24, 36, and 48

• BCVA increased the proportion of subjects with >10, >15, ≥30 words

  Compared with baseline, the proportion of subjects with 30 words of BCVA in the 24th and 52nd weeks of the study eye was improved \> 10, \>15, ≥ 30 words;

  in the 24th and 52nd weeks

• BCVA reduced the proportion of subjects < 10, < 15 words

  Compared with baseline, the proportion of subjects in both groups who studied eye bcVA at weeks 24 and 52 decreased \<10, \< 15 words

  at weeks 24 and 52

• Changes in the thickness of the macular fovea (CRT).

  Changes in the thickness of the macular fovea (CRT) at weeks 12, 24, 36, 48, and 52 were studied in both groups of subjects compared to baseline

  at weeks 12, 24, 36, 48, and 52

Secondary Outcomes (7)

• Vital signs

  Weeks 1 to 52

• physical examination

  Weeks 1 to 52

• Laboratory tests

  Weeks 1 to 52

• electrocardiogram（ ECG ）

  Weeks 1 to 52

• Antibiotic antibodies (ADA)

  Weeks 1 to 52

Other Outcomes (1)

• Immunogenicity evaluation

  Weeks 1 to 52

Study Arms (2)

Experimental group：BAT5906

EXPERIMENTAL

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.

Drug: BAT5906 injection

Control group：Lucentis®

ACTIVE COMPARATOR

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.

Drug: Lucentis

Interventions

BAT5906 injection DRUG

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

Experimental group：BAT5906

Lucentis DRUG

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

Control group：Lucentis®

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and sign the informed consent, and be willing to follow up according to the time specified in the trial;
• Age 50-85 years old (including boundary value), male and female;
• 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;
• The total area of the study eye lesions ≤30mm2(12 optic disc areas) was confirmed by the film reading center before randomization;
• 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;
• BCVA≥19 letters, equivalent to Snellen visual acuity ≥20/400, measured by ETDRS visual chart at screening and baseline in non-study eyes.

You may not qualify if:

• The study eyes received any intravitreal anti-VEGF therapy (such as bevacizumab, abbercept, ranibizumab, conbercept, etc.) within 3 months before randomization;
• 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;
• 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;
• 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;
• 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);
• 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);
• 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;
• 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;
• 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);
• 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;
• The study eyes had pupil afferent defect (APD);
• 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;
• Non-study eyes received photodynamic therapy (PDT) within 1 month before randomization;
• History of idiopathic or autoimmune associated uveitis in any eye;
• Pseudocyst stripping syndrome in any eye;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (48)

Affiliated Hospital of Inner Mongolia Medical University

Beijing, China

Location

Beijing Chao Yang Hospital

Beijing, China

Location

Beijing Hospital

Beijing, China

Location

China-Japan Friendship Hospital

Beijing, China

Location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

Xiangya Hospital of Central South University

Changsha, China

Location

The First Affiliated Hospital of Army Medical University (Southwest Hospital)

Chongqing, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

First Affiliated Hospital of Fujian Medical University

Fujian, China

Location

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, China

Location

Guangzhou Aier Eye Hospital

Guangzhou, China

Location

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

Guangzhou, China

Location

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Guangzhou, China

Location

Affiliated Hospital of Guizhou Medical University

Guiyang, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

The Second Hospital of Anhui Medical University

Hefei, China

Location

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

Hubei, China

Location

The First Hospital of Jilin University

Jilin, China

Location

Jinan Second People's Hospital

Jinan, China

Location

The Affiliated Eye Hospital of Shandong University of Chinese Medicine

Jinan, China

Location

Jinzhong First People's Hospital

Jinzhong, China

Location

The First People's Hospital of Kunming

Kunming, China

Location

Luoyang Third People's Hospital

Luoyang, China

Location

The Affiliated Eye Hospital of Nanchang University

Nanchang, China

Location

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjing, China

Location

Affiliated Hospital of Nantong University

Nantong, China

Location

Ningbo Eye Hospital

Ningbo, China

Location

Pingxiang People's Hospital

Pingxiang, China

Location

People's Hospital of Quzhou

Quzhou, China

Location

Huashan Hospital

Shanghai, China

Location

Shanghai Oriental Hospital

Shanghai, China

Location

Shanghai University of Traditional Chinese Medicine

Shanghai, China

Location

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

Shanghai, China

Location

Shantou University-Chinese University of Hong Kong Joint Shantou International Eye Centre

Shantou, China

Location

The Fourth People's Hospital of Shenyang

Shenyang, China

Location

Shenzhen People's Hospital

Shenzhen, China

Location

Second Hospital of Shanxi Medical University

Taiyuan, China

Location

Taizhou Hospital of Zhejiang Province

Taizhou, China

Location

Weifang Eye Hospital

Weifang, China

Location

Wenzhou Medical University Affiliated Optometry Hospital

Wenzhou, China

Location

Hebei Provincial Eye Hospital

Xingtai, China

Location

Xuzhou Central Hospital

Xuzhou, China

Location

Yantai Yuhuangding Hospital

Yantai, China

Location

Henan Eye Center (Henan Eye Hospital)

Zhengzhou, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

The Second People's Hospital of Zhengzhou

Zhengzhou, China

Location

Zunyi Medical College

Zunyi, China

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Youxin Chen, Doctor

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

• Xiaolin Liu, Doctor

  Affiliated Optometry Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Mingwei Zhao, Doctor

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Yi Chen, Doctor

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

• Hong Dai, Doctor

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

• Yong Tao, Doctor

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

• Linna Lu, Doctor

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

  PRINCIPAL INVESTIGATOR

• Hongping Cui, Doctor

  Shanghai Oriental Hospital

  PRINCIPAL INVESTIGATOR

• Xiaolin Liang, Doctor

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

  PRINCIPAL INVESTIGATOR

• Pengxia Wan, Doctor

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Yuqing Lan, Doctor

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Haoyu Chen, Doctor

  Shantou University-Chinese University of Hong Kong Joint Shantou International Eye Centre

  PRINCIPAL INVESTIGATOR

• Xiyuan Zhou, Doctor

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

• Xiaohong Meng, Doctor

  The First Affiliated Hospital of Army Medical University (Southwest Hospital)

  PRINCIPAL INVESTIGATOR

• Jinglin Yi, Doctor

  The Affiliated Eye Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

• Hongmei Zheng, Doctor

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

  PRINCIPAL INVESTIGATOR

• Liuhua Tong, Doctor

  People's Hospital of Quzhou

  PRINCIPAL INVESTIGATOR

• Zongming Song, Doctor

  Henan Eye Center (Henan Eye Hospital)

  PRINCIPAL INVESTIGATOR

• Shenzhi Liang, Doctor

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

• Junfeng Mao, Doctor

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Xiangwen Shu, Master

  Jinan Second People's Hospital

  PRINCIPAL INVESTIGATOR

• Yuanbin Li, Doctor

  Yantai Yuhuangding Hospital

  PRINCIPAL INVESTIGATOR

• Shanjun Cai, Doctor

  Zunyi Medical College

  PRINCIPAL INVESTIGATOR

• Xian Wang, Doctor

  Affiliated Hospital of Guizhou Medical University

  PRINCIPAL INVESTIGATOR

• Xu Li, Master

  The Fourth People's Hospital of Shenyang

  PRINCIPAL INVESTIGATOR

• Rongrong Zhu, Bachelor

  Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

• Wei Wei, Doctor

  Jiangsu Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Yabin Sun, Doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

• Liming Tao, Doctor

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

• Hongjian Ma, Doctor

  Aier Eye Hospital, Guangzhou

  PRINCIPAL INVESTIGATOR

• Yaohong Wu, Doctor

  Second Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

• Jian Guo, Doctor

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Xiaoling Luo, Doctor

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

• Qiuhong Liu, Doctor

  The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Xinquan Liu, Doctor

  Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Lifei Wang, Doctor

  Hebei Provincial Eye Hospital

  PRINCIPAL INVESTIGATOR

• Dan Zhu, Doctor

  The Affiliated Hospital of Inner Mongolia Medical University

  PRINCIPAL INVESTIGATOR

• Xuemei Pan, Master

  The Affiliated Eye Hospital of Shandong University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Yanfei Qiu, Doctor

  Pingxiang People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhen Zhang, Doctor

  Xuzhou Central Hospital

  PRINCIPAL INVESTIGATOR

• Jingbo Li, Doctor

  Luoyang Third People's Hospital

  PRINCIPAL INVESTIGATOR

• Xinyan Xu, Master

  Weifang Eye Hospital

  PRINCIPAL INVESTIGATOR

• Lan Li, Master

  The First People's Hospital of Kunming

  PRINCIPAL INVESTIGATOR

• Hongxia Yang, Bachelor

  Jinzhong First People's Hospital

  PRINCIPAL INVESTIGATOR

• Miaoqin Wu, Doctor

  Zhejiang Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhaozeng Lu, Doctor

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Gangfeng Cui, Doctor

  Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Quanyong Yi, Doctor

  Ningbo Eye Hospital

  PRINCIPAL INVESTIGATOR

• Ruifeng Wang, Doctor

  The Second People's Hospital of Zhengzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 30, 2022
• Study Start: July 7, 2022
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (48)