Actively Recruiting
Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy
Led by Beletalent (Zhuhai) Pharmaceutical Co., Ltd · Updated on 2025-08-24
360
Participants Needed
30
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if drug TNTL works to treat non-proliferative diabetic retinopathy in adults. It will also learn about the safety of drug TNTL. The main questions it aims to answer are: 1. Does drug TNTL can improve visual acuity and reduce the degree of retinopathy? 2. What medical problems do participants have when taking drug TNTL? Researchers will compare drug TNTL to a placebo (a look-alike substance that contains no drug) to see if drug TNTL works to treat non-proliferative diabetic retinopathy. Participants will: 1. Take drug TNTL or a placebo every day for 6 months 2. Visit the clinic once every 4 weeks for checkups and tests 3. Keep a diary of their symptoms and Change from baseline
CONDITIONS
Official Title
Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Diagnosed with type 2 diabetes and non-proliferative diabetic retinopathy classified as mild or moderate
- Best corrected visual acuity (BCVA) in the target eye is 34 points or higher on the ETDRS chart (equivalent to 20/200 vision)
- Meet traditional Chinese medicine criteria for Yin deficiency, internal heat, and eye meridian stasis
- Glycated hemoglobin (HbA1c) is 8.5% or lower during screening
- Willing to participate and sign informed consent
You will not qualify if you...
- No light perception in one eye
- Macular edema requiring anti-VEGF treatment
- Other eye diseases such as retinal artery or vein occlusion, retinal detachment, uveitis, glaucoma, corneal ulcer, cataract affecting fundus exam, optic neuropathy, or high myopia with fundus changes
- Acute diabetes complications within one year before screening
- Other diabetic eye complications like iris neovascularization, angle neovascularization, or retinal neovascularization
- Use of traditional Chinese external treatments for diabetic retinopathy within one week before enrollment
- Use of specific drugs for diabetic retinopathy within two weeks before enrollment
- Eye surgeries or procedures in the target eye within three months before enrollment
- Cataract surgery in the target eye within three months before enrollment without stabilization
- Intravitreal injections of anti-VEGF or glucocorticoids in the target eye within three months before enrollment
- Total retinal laser photocoagulation treatment in the target eye
- Turbid refractive media preventing fundus evaluation
- Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg
- Liver enzymes ALT or AST ≥1.5 times upper limit of normal at screening
- Serious kidney disease or diabetes foot
- Severe primary diseases or mental illness
- History or suspicion of alcohol or drug abuse
- Pregnant, lactating, or planning pregnancy; lack of contraception agreement
- Allergy to study drugs or components
- Participation in other clinical trials within past month
- Investigator's judgment that participation is unsuitable
AI-Screening
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Trial Site Locations
Total: 30 locations
1
Xuancheng People's Hospital
Xuancheng, Anhui, China, 242000
Actively Recruiting
2
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
3
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510405
Actively Recruiting
4
Shenzhen Eye Hospital
Shenzhen, Guangdong, China, 518040
Actively Recruiting
5
Zhuhai People's Hospital
Zhuhai, Guangdong, China, 519099
Actively Recruiting
6
The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Guiyang, Guizhou, China, 550001
Actively Recruiting
7
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
Actively Recruiting
8
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China, 050011
Actively Recruiting
9
Kaifeng Central Hospital
Kaifeng, Henan, China, 475000
Actively Recruiting
10
Luoyang Third People's Hospital
Luoyang, Henan, China, 471099
Actively Recruiting
11
Xinxiang Central Hospital
Xinxiang, Henan, China, 453001
Actively Recruiting
12
People's Hospital of Zhengzhou
Zhengzhou, Henan, China, 450014
Actively Recruiting
13
Zhengzhou Second Hospital
Zhengzhou, Henan, China, 450015
Actively Recruiting
14
Taihe Hospital （Affiliated Hospital Of Hubei University Of Medicine）
Shiyan, Hubei, China, 442099
Actively Recruiting
15
Wuhan Puren Hospital
Wuhan, Hubei, China, 430080
Actively Recruiting
16
Yichang Central People's Hospital
Yichang, Hubei, China, 443000
Actively Recruiting
17
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, China, 421001
Actively Recruiting
18
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214023
Actively Recruiting
19
Affiliated Zhongshan Hospital Dalian University
Dalian, Liaoning, China, 116001
Actively Recruiting
20
Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
Jinan, Shandong, China, 250011
Actively Recruiting
21
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Jinan, Shandong, China, 250012
Actively Recruiting
22
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
Actively Recruiting
23
Shandong Second Provincial General Hospital
Jinan, Shandong, China, 250022
Actively Recruiting
24
Liaocheng People's Hospital
Liaocheng, Shandong, China, 252000
Actively Recruiting
25
The First People'S Hospitalof Xian Yang
Xianyang, Shanxi, China, 712000
Actively Recruiting
26
Xian No.1 Hospital
Xi’an, Shanxi, China, 710002
Actively Recruiting
27
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China, 710077
Actively Recruiting
28
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuang, China, 646099
Actively Recruiting
29
Panzhihua Integrated Traditional Chinese and Western Medicine Hospital
Panzhihua, Sichuang, China, 617000
Actively Recruiting
30
Yunnan University Affiliated Hospital
Kunming, Yunnan, China, 650021
Actively Recruiting
Research Team
J
Jinxin Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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