Actively Recruiting
Efficacy Evaluation Study of 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
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter, randomized, double-blind, parallel-group, active-controlled non-inferiority trial. A total of 406 subjects with diabetic macular edema (DME) were planned for enrollment. After screening, eligible subjects were randomized in a 1:1 ratio to the treatment group or the control group. The treatment group received BAT5906 injection, while the control group received Lucentis®. During the trial, ophthalmic examinations and safety assessments were conducted according to the protocol for efficacy and safety evaluation. Blood samples were collected for immunogenicity assessment. The primary endpoint was the mean change in best-corrected visual acuity (BCVA) in the study eye from baseline to week 52 (measured using the ETDRS chart).
CONDITIONS
Official 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
- Diagnosed with type 1 or type 2 diabetes, aged 18 to 80 years
- Diabetic macular edema involving the macular center in the study eye
- Central retinal thickness of study eye greater than 300 µm (or >320 µm for Heidelberg OCT)
- Best-corrected visual acuity in study eye between 73 and 21 letters on ETDRS chart (approx. 20/40 to 20/400)
- Contralateral eye visual acuity greater than 24 letters on ETDRS chart (approx. better than 20/320)
You will not qualify if you...
- Structural damage in central macula that may prevent vision improvement
- Vitreomacular traction or epimacular membrane impairing vision
- Other eye diseases that affect vision or retinal evaluation
- Aphakia or intraocular lens with posterior capsule opacification without 1-month washout
- Uncontrolled glaucoma or history/planned glaucoma surgery
- Prior vitreoretinal surgery or scleral buckling in study eye
- Recent or planned panretinal photocoagulation (PRP) in study eye
- Neovascular glaucoma or significant iris lesions in study eye
- Active proliferative diabetic retinopathy in study eye
- Recent or planned intraocular surgery in study eye
- Media opacities interfering with vision or examination
- Recent intravitreal or systemic corticosteroid use exceeding specified limits
- Spherical refractive error exceeding -6.0 diopters or axial length over 26 mm if surgery history
- History of uveitis or active ocular infection in either eye
- Anti-VEGF therapy in study eye or systemically within 90 days prior to randomization
- Abnormal liver, kidney function or coagulation as defined
- Active infections including hepatitis B or C, HIV, or syphilis
- Recent cardiovascular or thromboembolic events within 6 months
- Poorly controlled diabetes (HbA1c >11%) or uncontrolled hypertension
- Recent surgery with unhealed wounds
- Diagnosed systemic autoimmune or uncontrolled clinical conditions
- Known allergy or contraindication to study drugs or components
- Participation in another drug trial within 90 days
- Pregnancy, lactation, or refusal to use contraception
- Any other conditions deemed exclusionary by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
Z
Zhaohe Wang, Ph.D
CONTACT
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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