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Neovascular (Wet) Age-related Macular DegenerationPhase 3NCT05439629

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

A Phase 3 study testing BAT5906 injection and Lucentis in people with Neovascular (Wet) Age-related Macular Degeneration, run by Bio-Thera Solutions at 48 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 85 years
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
488 participants
Where
48 sitesChina
Study dates
7 Jul 2022to 22 Apr 2025
Phase
Phase 3
Are there results?
None posted in the registry

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 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 30Show fewer
  • 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;
  • Active eye infection in any eye (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, iridecocyclitis, endophthalmitis);
  • 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;
  • 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;
  • 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;
  • Presence of clinically significant active systemic infectious disease under treatment;
  • 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;
  • 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;
  • Poorly controlled hypertension before randomization (defined as sitting systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg after antihypertensive medication);
  • Any uncontrollable clinical problems (such as serious mental, neurological, cardiovascular, respiratory and other system diseases and malignant tumors);
  • 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);
  • Abnormal coagulation function (prothrombin time > upper limit of normal 3 seconds or activated partial thromboplastin time > upper limit of normal 10 seconds);
  • 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);
  • 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;
  • 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;
  • The researcher believes that it is not suitable for this study.

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

China48 sites

  • Affiliated Hospital of Inner Mongolia Medical University

    Beijing

  • Beijing Chao Yang Hospital

    Beijing

  • Beijing Hospital

    Beijing

  • China-Japan Friendship Hospital

    Beijing

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing

  • Peking University People's Hospital

    Beijing

  • Xiangya Hospital of Central South University

    Changsha

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

    Chongqing

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing

  • First Affiliated Hospital of Fujian Medical University

    Fujian

  • First Affiliated Hospital, Sun Yat-Sen University

    Guangzhou

  • Guangzhou Aier Eye Hospital

    Guangzhou

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

    Guangzhou

  • The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

    Guangzhou

  • Affiliated Hospital of Guizhou Medical University

    Guiyang

  • Zhejiang Provincial People's Hospital

    Hangzhou

  • The Second Hospital of Anhui Medical University

    Hefei

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

    Hubei

  • The First Hospital of Jilin University

    Jilin City

  • Jinan Second People's Hospital

    Jinan

  • The Affiliated Eye Hospital of Shandong University of Chinese Medicine

    Jinan

  • Jinzhong First People's Hospital

    Jinzhong

  • The First People's Hospital of Kunming

    Kunming

  • Luoyang Third People's Hospital

    Luoyang

  • The Affiliated Eye Hospital of Nanchang University

    Nanchang

  • Jiangsu Provincial Hospital of Traditional Chinese Medicine

    Nanjing

  • Affiliated Hospital of Nantong University

    Nantong

  • Ningbo Eye Hospital

    Ningbo

  • Pingxiang People's Hospital

    Pingxiang

  • People's Hospital of Quzhou

    Quzhou

  • Huashan Hospital

    Shanghai

  • Shanghai Oriental Hospital

    Shanghai

  • Shanghai University of Traditional Chinese Medicine

    Shanghai

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

    Shanghai

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

    Shantou

  • The Fourth People's Hospital of Shenyang

    Shenyang

  • Shenzhen People's Hospital

    Shenzhen

  • Second Hospital of Shanxi Medical University

    Taiyuan

  • Taizhou Hospital of Zhejiang Province

    Taizhou

  • Weifang Eye Hospital

    Weifang

  • Wenzhou Medical University Affiliated Optometry Hospital

    Wenzhou

  • Hebei Provincial Eye Hospital

    Xingtai

  • Xuzhou Central Hospital

    Xuzhou

  • Yantai Yuhuangding Hospital

    Yantai

  • Henan Eye Center (Henan Eye Hospital)

    Zhengzhou

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

  • The Second People's Hospital of Zhengzhou

    Zhengzhou

  • Zunyi Medical College

    Zunyi

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 and Ranibizumab (Lucentis®) in Patients With Neovascular Age-related Macular Degeneration

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.

Read the detailed description

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.

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.

Being tested
BAT5906 injection, Lucentis
Medical subject headings
Macular Degeneration

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 NCT05439629
Study groupRoleWhat they receive
Experimental group：BAT5906ExperimentalIntravitreal injection; Dosage: 4.0 mg / eye / time, 50 μl; Duration of administration: every 4 weeks, administered to week 48, not administered at 52 weeks.
Receives: Drug: BAT5906 injection
Control group：Lucentis®Active comparatorIntravitreal injection; Dosage: 0.5 mg / eye / time, 50 μl; Duration of administration: every 4 weeks, administered to week 48, not administered at 52 weeks.
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

  2. 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

    Measured: at weeks 12, 24, 36, and 48

  3. 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;

    Measured: in the 24th and 52nd weeks

  4. 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

    Measured: at weeks 24 and 52

  5. 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

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

Secondary outcomes (7)

  1. Vital signs

    Number of participants with abnormal vital signs

    Measured: Weeks 1 to 52

  2. physical examination

    Number of participants with abnormal physical examination findings

    Measured: Weeks 1 to 52

  3. Laboratory tests

    Number of participants with abnormal laboratory test results

    Measured: Weeks 1 to 52

  4. electrocardiogram（ ECG ）

    Number of participants with abnormal ECG readings

    Measured: Weeks 1 to 52

  5. Antibiotic antibodies (ADA)

    Resistance antibody (ADA) situation in the subject

    Measured: Weeks 1 to 52

  6. Adverse events（AE）

    Ocular and non-ocular adverse events (AE) and serious adverse events (SAE)

    Measured: Weeks 1 to 52

  7. Adverse events of particular concern (possible adverse reactions to the eye)

    Endophthalmia, increased intraocular pressure, subconjunctival hemorrhage, ocular foreign body sensation, visual impairment, corneal abrasions, lens damage, retinal detachment, retinal artery occlusion, etc.; Possible systemic adverse effects include non-ocular bleeding, increased blood pressure, and thromboembolic events

    Measured: Weeks 1 to 52

Timeline

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

  1. First posted30 Jun 2022
  2. Study start7 Jul 2022
  3. Primary completion22 Apr 2025
  4. Study completion22 Apr 2025

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
488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05439629
Sponsor's protocol ID
BAT5906-004-CR
Status last verified
Dec 2025
First submitted
13 Jun 2022
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BAT5906 injection and Lucentis in people with Neovascular (Wet) Age-related Macular Degeneration, run by Bio-Thera Solutions at 48 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 6 inclusion and 30 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: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in the BCVA value (time frame: Week 52). The study lists 5 primary outcomes in all. 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 NCT05439629.

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 8 Dec 2025.

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