Actively Recruiting
A Multicenter, Randomized, Double-Blind Phase III Clinical Study Comparing BAT5906 and Lucentis® in Patients With Diabetic Macular Edema
Led by Bio-Thera Solutions · Updated on 2026-04-07
406
Participants Needed
50
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of BAT5906 compared to Lucentis® in people with diabetic macular edema (DME). This multicenter, randomized, double-blind trial plans to enroll 406 participants aged 18 to 80 years who have DME affecting the central part of the retina. The primary goal is to assess changes in best-corrected visual acuity (BCVA) from the start of the study to week 52 using the ETDRS chart. Participants are randomly assigned to receive either BAT5906 or Lucentis® through intravitreal injections directly into the eye. Each treatment is given once every 4 weeks for three doses, followed by monitoring visits every 4 weeks with possible additional doses as needed, continuing through week 52. BAT5906 is administered at 4.0 mg per eye, while Lucentis® is given at 0.5 mg per eye. Throughout the study, participants undergo regular eye exams, safety assessments, and blood tests to monitor immune response. Researchers measure visual acuity changes to determine treatment effects. The study includes ongoing safety monitoring and assessments until week 52 to evaluate both treatments' effectiveness and safety in managing DME.
CONDITIONS
Brief Title
Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study visits and procedures
- Diagnosis of type 1 or type 2 diabetes, aged 18 to 80 years
- Diabetic macular edema involving the center of the retina in the study eye
- Central retinal thickness over 300 μm (or over 320 μm by Heidelberg OCT) in the study eye
- Best-corrected visual acuity between 73 and 21 letters on the ETDRS chart in the study eye
- Contralateral eye visual acuity over 24 letters on the ETDRS chart
- If both eyes qualify, the eye with poorer visual acuity is selected unless otherwise decided by the investigator
You will not qualify if you...
- Structural damage in the central macula preventing vision improvement
- Conditions in the study eye other than diabetic macular edema affecting evaluation
- Aphakia or intraocular lens with posterior capsule opacification without 1-month washout after YAG capsulotomy
- Uncontrolled glaucoma or history/planned glaucoma surgery in the study eye
- Prior vitreoretinal surgery or scleral buckling in the study eye
- Recent or planned panretinal photocoagulation (PRP) in the study eye
- Neovascular glaucoma, iris neovascularization, or abnormal iris lesions in the study eye
- Active proliferative diabetic retinopathy in the study eye
- Recent or planned intraocular surgery in the study eye
- Opacities interfering with vision or fundus examination in the study eye
- Recent corticosteroid injections or therapy as specified in study criteria
- High spherical refractive error exceeding -6.0 diopters or long axial length
- History of uveitis or active ocular infection in either eye
- Anti-VEGF therapy within 90 days before randomization
- Abnormal liver, renal, or coagulation function as defined
- Active infections including hepatitis B, C, HIV, or syphilis
- Recent cardiovascular or thromboembolic events
- Poorly controlled diabetes or high HbA1c over 11%
- Uncontrolled hypertension despite treatment
- Recent surgery with unhealed wounds
- Systemic autoimmune or uncontrolled clinical conditions
- Allergies or contraindications to study drugs or related substances
- Participation in other drug clinical trials within 90 days
- Pregnancy, lactation, or refusal to use contraception during and after the study
- Other investigator-determined exclusion conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive intravitreal injections of BAT5906 or Lucentis once every 4 weeks for 3 consecutive doses.
3 visits (in-person)
Duration - Up to Week 52
Participants are monitored every 4 weeks after initial doses, with additional dosing at investigator discretion.
Monthly visits for up to 40 weeks
Trial Site Locations
Total: 50 locations
1
Beijing Aier Yingzhi Eye Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Peking University Third Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
4
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
5
Gansu Provincial People's Hospital
Lanzhou, Gansu, China
Active, Not Recruiting
6
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China
Actively Recruiting
7
Guangzhou Aier Eye Hospital
Guangzhou, Guangdong, China
Actively Recruiting
8
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
9
Shantou University-The Chinese University of Hong Kong Joint Shantou International Eye Center
Shantou, Guangdong, China
Actively Recruiting
10
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Actively Recruiting
11
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China
Actively Recruiting
12
Zunyi Medical University Affiliated Hospital
Zunyi, Guizhou, China
Actively Recruiting
13
Cangzhou Central Hospital
Cangzhou, Hebei, China
Actively Recruiting
14
Shijiazhuang Municipal People's Hospital
Shijiazhuang, Hebei, China
Actively Recruiting
15
Hebei Eye Hospital
Xingtai, Hebei, China
Actively Recruiting
16
Luoyang Third People's Hospital
Luoyang, Henan, China
Actively Recruiting
17
Henan Eye Center (Henan Provincial Eye Hospital)
Zhengzhou, Henan, China
Actively Recruiting
18
Zhengzhou Second People's Hospital
Zhengzhou, Henan, China
Actively Recruiting
19
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
20
Wuhan Central Hospital
Wuhan, Hubei, China
Actively Recruiting
21
Wuhan Puren Hospital
Wuhan, Hubei, China
Actively Recruiting
22
Wuhan University People's Hospital (Hubei Provincial People's Hospital)
Wuhan, Hubei, China
Actively Recruiting
23
Changsha Aier Eye Hospital
Changsha, Hunan, China
Actively Recruiting
24
Nanjing Medical University Eye Hospital
Nanjing, Jiangsu, China
Terminated
25
Wuxi Municipal People's Hospital
Wuxi, Jiangsu, China
Actively Recruiting
26
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
27
The Second Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
28
Panjin Liaoyang Gem Flower Hospital
Panjin, Liaoning, China
Actively Recruiting
29
Shenyang Fourth People's Hospital
Shenyang, Liaoning, China
Actively Recruiting
30
Inner Mongolia Medical University Affiliated Hospital
Neimeng, Neimenggu, China
Actively Recruiting
31
Jinan Second People's Hospital
Jinan, Shandong, China
Actively Recruiting
32
Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
Jinan, Shandong, China
Actively Recruiting
33
Weifang Eye Hospital
Weifang, Shandong, China
Actively Recruiting
34
Weifang Medical University Affiliated Hospital
Weifang, Shandong, China
Actively Recruiting
35
Longhua Hospital Affiliated with Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
36
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
37
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
38
Shanxi Provincial Eye Hospital
Taiyuan, Shanxi, China
Actively Recruiting
39
Xianyang First People's Hospital
Xianyang, Shanxi, China
Actively Recruiting
40
Xi'an First Hospital
Xi’an, Shanxi, China
Actively Recruiting
41
Xi'an Fourth Hospital
Xi’an, Shanxi, China
Actively Recruiting
42
Chengdu University of Traditional Chinese Medicine Affiliated Hospital
Chengdu, Sichuan, China
Actively Recruiting
43
Chengdu University of Traditional Chinese Medicine Yinhai Eye Hospital
Chengdu, Sichuan, China
Terminated
44
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
45
Deyang People's Hospital
Deyang, Sichuan, China
Actively Recruiting
46
The Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
47
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
48
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
49
Taizhou Hospital, Zhejiang Province
Taizhou, Zhejiang, China
Actively Recruiting
50
Wenzhou Medical University Eye Hospital
Wenzhou, Zhejiang, China
Actively Recruiting
Research Team
X
Xizhen Hu
Z
Zhaohe Wang, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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