Non-Proliferative Diabetic RetinopathyPhase 3TNTLNCT06817265
Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy
A Phase 3 study testing TNTL and TNTL simulation preparation in people with Non-Proliferative Diabetic Retinopathy, run by Beletalent (Zhuhai) Pharmaceutical Co., Ltd at 30 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Proliferative Diabetic Retinopathy
- What is being tested?
- TNTL and TNTL simulation preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 30 sitesChina
- Study dates
- 29 Apr 2025to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range of 18 to 75 years old (including boundary values);
- Conform to the diagnosis of type 2 diabetes and diabetes retinopathy. diabetes retinopathy is classified as NPDR and mild and moderate patients;
- Patients with the best corrected visual acuity (BCVA) of the target eye is ≥ 34 points (ETDRS visual acuity chart, visual acuity equivalent to a score of 20/200, decimal 0.1);
- Patients who meet the syndrome differentiation criteria of Yin deficiency, internal heat, and eye meridian stasis in traditional Chinese medicine;
- During the screening period, glycated hemoglobin (HbA1c) should be ≤ 8.5%;
- Agree to participate in this clinical study and voluntarily sign the informed consent form.
Who cannot join
- Patients with no light perception in one eye;
- Patients with macular edema who require anti Vascular Endothelial Growth Factor(VEGF) treatment;
- People with other eye diseases, such as retinal artery or vein occlusion, non diabetes retinopathy, retinal detachment, uveitis, glaucoma, corneal ulcer, cataract affecting fundus examination, optic neuropathy and high myopia with fundus changes;
- Patients with acute complications of diabetes (such as diabetes ketoacidosis, hyperglycemia hyperosmolality syndrome, diabetes lactic acidosis, etc.) within one year before the screening period;
- People with other eye related complications of diabetes, such as iris neovascularization, angle neovascularization, and retinal neovascularization;
- acupuncture and moxibustion and other external treatment methods of traditional Chinese medicine were used to treat diabetes retinopathy within one week before enrollment;
Show all 21Show fewer
- Patients who have used drugs clearly stated in the instruction manual to treat diabetes retinopathy, such as calcium dobesilate, pancreatic kallidinogenase, Qiming Granules, Shuangdan Mingmu Capsules, Compound Danshen Dropping Pills, Tongluo Mingmu Capsules, etc. within 2 weeks before enrollment;
- Patients who have undergone glaucoma, vitreous, retinal and other intraocular surgeries and procedures in the target eye within 3 months before enrollment;
- Patients who have undergone cataract surgery in the target eye within 3 months prior to enrollment and have not yet stabilized according to the researcher's assessment;
- Patients who have received intravitreal injections of anti VEGF antibodies and glucocorticoids in the target eye within 3 months prior to enrollment;
- Patients who have undergone total retinal laser photocoagulation treatment in the target eye;
- For those whose refractive media is turbid and difficult to evaluate fundus images in the target eye;
- Uncontrolled or controlled blood pressure with systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg;
- When screening, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) should be ≥ 1.5 times the upper limit of normal value;
- Patients with serious kidney disease (such as azotemia and uremia), diabetes foot, etc;
- When screening, individuals with severe primary diseases such as respiratory, cardiovascular, cerebrovascular, endocrine, digestive, and hematopoietic systems, or those with severe mental illnesses should be included;
- Suspected or confirmed history of alcohol or drug abuse;
- Pregnant women, lactating women, or women of childbearing age who are preparing to conceive; Female subjects of childbearing age or male subjects (with partners of childbearing age) who do not agree to voluntarily take effective contraceptive measures within one month after the last dose during the screening period;
- Individuals who are allergic to the drugs or their components used in this experiment;
- Participants who have participated in other clinical trials within the past month;
- The researchers believe that participants should not participate in the clinical trial.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites, 30 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Yong Tao, +086 13910308908, taoyong@mail.ccmu.edu.cn
Yong Tao
- Recruiting
Affiliated Zhongshan Hospital Dalian University
Dalian, Liaoning, 116001
Wei Duan, +086 13940839879, duanwei34@hotmail.com
Qian Yang
- Recruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510405
Hong Liu, +086 13572876766, liuhongtry100@sina.com
Hong Liu
- Recruiting
The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Guiyang, Guizhou, 550001
Limin Wang, +086 13710616456, 3620998236@qq.com
Limin Wang
- Recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Hongpei Ji, +086 18585006622, 1755240181@qq.com
Hongpei Ji
- Recruiting
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, 421001
Gang Tan, +086 13907343001, tangang99@hotmail.com
Gang Tan
- Recruiting
Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
Jinan, Shandong, 250011
Hongsheng Bi, +086 18085117112, hongshengbi@126.com
Hongsheng Bi
- Recruiting
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Jinan, Shandong, 250012
Meirong Chen, +086 13065066352, langhongyerong@163.com
Meirong Chen
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
Luxin Ma, +086 15168887693, 15168887693@163.com
Luxin Ma
- Recruiting
Shandong Second Provincial General Hospital
Jinan, Shandong, 250022
Hong Wang, +086 13969058801, wanghong630223@163.com
Hong Wang
- Recruiting
Kaifeng Central Hospital
Kaifeng, Henan, 475000
Hongmei Mu, +086 15837815666, muhongmeik@126.com
Hongmei Mu
- Recruiting
Yunnan University Affiliated Hospital
Kunming, Yunnan, 650021
Min Wu, +086 18908809399, ynwumin@126.com
Min Wu
- Recruiting
Liaocheng People's Hospital
Liaocheng, Shandong, 252000
Xinying You, +086 13953113696, youyou7688@126.com
Xinying You
- Recruiting
Luoyang Third People's Hospital
Luoyang, Henan, 471099
Jingbo Li, +086 13643897923, lyljb01@163.com
Jingbo Li
- Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuang, 646099
Hongshan Lv, +086 13550885588, oculistlvhongbin@163.com
Hongshan Lv
- Recruiting
Panzhihua Integrated Traditional Chinese and Western Medicine Hospital
Panzhihua, Sichuang, 617000
Libin Zhou, +086 13982321888, zlblqh@126.com
Libin Zhou
- Recruiting
Shenzhen Eye Hospital
Shenzhen, Guangdong, 518040
Wei Chi, +086 13710616456, dr_chiwei@163.com
Wei Chi
- Recruiting
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, 050011
Qian Ren, +086 17603119856, 17603119856@163.com
Qian Ren
- Recruiting
Taihe Hospital （Affiliated Hospital Of Hubei University Of Medicine）
Shiyan, Hubei, 442099
Yong Zhang, +086 13710616456, inforzy@163.com
Yong Zhang
- Recruiting
Wuhan Puren Hospital
Wuhan, Hubei, 430080
Yumin Gui, +086 13707152515, 5537468@qq.com
Yumin Gui
- Recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
Yong Yao, +086 13301518688, pard1@126.com
Yong Yao
- Recruiting
Xian No.1 Hospital
Xi’an, Shanxi, 710002
Huiqin Lu, +086 13389255280, 13389255280@163.com
Huiqin Lu
- Recruiting
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, 710077
Ying Deng, +086 15237321701, xady2008@163.com
Ying Deng
- Recruiting
The First People'S Hospitalof Xian Yang
Xianyang, Shanxi, 712000
Lihua Hou, 18220010523, houlihua1018@163.com
Lihua Hou
- Recruiting
Xinxiang Central Hospital
Xinxiang, Henan, 453001
Ximin Feng, +086 15237321701, fengximin00@163.com
Ximin Feng
- Recruiting
Xuancheng People's Hospital
Xuancheng, Anhui, 242000
Shenghua Dong, +086 13013133123, Xcsyydsh@163.com
Shenghua Dong
- Recruiting
Yichang Central People's Hospital
Yichang, Hubei, 443000
Yan Zhang, 13647177003, caoshuzhangyan@163.com
Yan Zhang
- Recruiting
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450014
Yuanyuan Yan, +086 13526696829, 1165581980@qq.com
Yuanyuan Yan
- Recruiting
Zhengzhou Second Hospital
Zhengzhou, Henan, 450015
Xuexia Gao, +086 13837199867, gaoxuexia2003@163.com
Xuexia Gao
- Recruiting
Zhuhai People's Hospital
Zhuhai, Guangdong, 519099
Hongyun Lu, +086 13902533020, luhongyun2013@163.com
Hongyun Lu
About this study
Official title: Phase III Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy(With Syndrome of Yin Deficiency With Internal Heat and Blood Stasis Obstructing the Collaterals of the Eyes)
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:
- Does drug TNTL can improve visual acuity and reduce the degree of retinopathy?
- 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.
Read more
Participants will:
- Take drug TNTL or a placebo every day for 6 months
- Visit the clinic once every 4 weeks for checkups and tests
- Keep a diary of their symptoms and Change from baseline
- Conditions
- Non-Proliferative Diabetic Retinopathy
- Being tested
- TNTL, TNTL simulation preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNTLDrug
oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
TNTL simulation preparationDrug
oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TNTL Experimental Group | Active comparator | TNTL, oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks. Receives: Drug: TNTL |
| TNTL Control Group | Placebo comparator | TNTL simulation preparation，oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks. Receives: Drug: TNTL simulation preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best corrected visual acuity (BCVA) from baseline after 24 weeks of medication;
After 24 weeks of medication, the subjects' best corrected visual acuity (BCVA) was checked and compared with the value measured at week 0 to observe the degree of change from baseline value;
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (9)
Change in best corrected visual acuity (BCVA) from baseline after medication
After 4 weeks,8weeks,12weeks,16weeks,20weeks of medication, the subjects' best corrected visual acuity (BCVA) was checked separately and compared with the value measured at week 0 to observe the degree of change from baseline value;
Measured: From enrollment to the end of treatment at 4 weeks,8weeks,12weeks,16weeks,20weeks
The change and progression rate of ETDRS classification DR Classification from baseline after 12 and 24 weeks of medication;
After 12 weeks，24 weeks of medication, the subjects' ETDRS classification based on the Diabetic Retinopathy Severity Score and compared with the value measured at week 0 to observe the change and progression rate from baseline value as required, with a minimum score of 10 and a maximum score of 90. The higher the score, the more severe it is.
Measured: From enrollment to the end of treatment at 12weeks and 24weeks.
The proportion of subjects whose best corrected visual acuity (BCVA)increased by ≥ 5, ≥ 10, ≥ 15 compared to baseline after medication;
After 4,8,12,16,20,24 weeks of medication, count the proportion of subjects whose best corrected visual acuity(BCVA) increased by ≥ 5, ≥ 10, ≥ 15 compared to baseline
Measured: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
The proportion of subjects whose best corrected visual acuity (BCVA) decreased by ≥ 5, ≥ 10, ≥ 15 compared to baseline after medication
After 4,8,12,16,20,24 weeks of medication, count the proportion of subjects whose best corrected visual acuity(BCVA) decreased by ≥ 5, ≥ 10, ≥ 15 compared to baseline
Measured: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
Changes in fundus condition compared to baseline
Changes in fundus condition compared to baseline after 12 and 24 weeks of medication
Measured: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in retinal macular optical coherence tomography (OCT) compared to baseline
Changes in retinal macular optical coherence tomography(OCT) after 12 and 24 weeks of medication compared to baseline
Measured: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in HemoglobinA1c compared to baseline
Changes in HemoglobinA1c levels compared to baseline after 12 and 24 weeks of medication
Measured: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in fasting blood glucose compared to baseline
Changes in fasting blood glucose levels after 4, 8, 12, 16, 20, and 24 weeks of medication compared to baseline
Measured: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
Effective rate of traditional Chinese medicine syndrome
After medication, use the Traditional Chinese Medicine Syndrome（yin deficiency with internal heat and blood stasis obstructing the collaterals of the eyes） Scale as required to score and calculate the effective rate,the lowest score is 0, the highest score is 30, and the higher the score, the more severe it is.
Measured: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start29 Apr 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beletalent (Zhuhai) Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongsheng Bi, Principal investigator, Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817265
- Sponsor's protocol ID
- TNTL-DR-20241112
- Acronym
- TNTL
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy(With Syndrome of Yin Deficiency With Internal Heat and Blood Stasis Obstructing the Collaterals of the Eyes)
- ClinicalTrials.gov ID
- NCT06817265
- Acronym / sponsor ID
- TNTL / TNTL-DR-20241112
- Conditions
- Non-Proliferative Diabetic Retinopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Beletalent (Zhuhai) Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does drug TNTL can improve visual acuity and reduce the degree of retinopathy?
- 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:
- Take drug TNTL or a placebo every day for 6 months
- Visit the clinic once every 4 weeks for checkups and tests
- Keep a diary of their symptoms and Change from baseline
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNTL Experimental Group | Active comparator | Drug: TNTLTNTL, oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks. |
| TNTL Control Group | Placebo comparator | Drug: TNTL simulation preparationTNTL simulation preparation，oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range of 18 to 75 years old (including boundary values);
- Conform to the diagnosis of type 2 diabetes and diabetes retinopathy. diabetes retinopathy is classified as NPDR and mild and moderate patients;
- Patients with the best corrected visual acuity (BCVA) of the target eye is ≥ 34 points (ETDRS visual acuity chart, visual acuity equivalent to a score of 20/200, decimal 0.1);
- Patients who meet the syndrome differentiation criteria of Yin deficiency, internal heat, and eye meridian stasis in traditional Chinese medicine;
- During the screening period, glycated hemoglobin (HbA1c) should be ≤ 8.5%;
Key exclusion criteria (21 listed)
- Patients with no light perception in one eye;
- Patients with macular edema who require anti Vascular Endothelial Growth Factor(VEGF) treatment;
- People with other eye diseases, such as retinal artery or vein occlusion, non diabetes retinopathy, retinal detachment, uveitis, glaucoma, corneal ulcer, cataract affecting fundus examination, optic neuropathy and high myopia with fundus changes;
- Patients with acute complications of diabetes (such as diabetes ketoacidosis, hyperglycemia hyperosmolality syndrome, diabetes lactic acidosis, etc.) within one year before the screening period;
- People with other eye related complications of diabetes, such as iris neovascularization, angle neovascularization, and retinal neovascularization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNTLoral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks. | Drug | TNTL Experimental Group |
| TNTL simulation preparationoral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks. | Drug | TNTL Control Group |
Primary outcome
Change in best corrected visual acuity (BCVA) from baseline after 24 weeks of medication;
Time frame: From enrollment to the end of treatment at 24 weeks
After 24 weeks of medication, the subjects' best corrected visual acuity (BCVA) was checked and compared with the value measured at week 0 to observe the degree of change from baseline value;
9 secondary outcomes
Change in best corrected visual acuity (BCVA) from baseline after medication
Time frame: From enrollment to the end of treatment at 4 weeks,8weeks,12weeks,16weeks,20weeks
The change and progression rate of ETDRS classification DR Classification from baseline after 12 and 24 weeks of medication;
Time frame: From enrollment to the end of treatment at 12weeks and 24weeks.
The proportion of subjects whose best corrected visual acuity (BCVA)increased by ≥ 5, ≥ 10, ≥ 15 compared to baseline after medication;
Time frame: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
The proportion of subjects whose best corrected visual acuity (BCVA) decreased by ≥ 5, ≥ 10, ≥ 15 compared to baseline after medication
Time frame: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
Changes in fundus condition compared to baseline
Time frame: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in retinal macular optical coherence tomography (OCT) compared to baseline
Time frame: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in HemoglobinA1c compared to baseline
Time frame: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in fasting blood glucose compared to baseline
Time frame: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
Effective rate of traditional Chinese medicine syndrome
Time frame: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Non-Proliferative Diabetic Retinopathy
Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
Proliferative Diabetic Retinopathy (PDR)
RecruitingPhase 2/3
Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
Diabetic Retinopathy
RecruitingPhase 2
A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
Diabetic Retinopathy
Active, not recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01
Diabetic Retinopathy, NPDR - Non Proliferative Diabetic Retinopathy
RecruitingPhase 1
A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
Diabetic Macular Edema, Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongsheng Bi principal investigator
Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TNTL and TNTL simulation preparation in people with Non-Proliferative Diabetic Retinopathy, run by Beletalent (Zhuhai) Pharmaceutical Co., Ltd at 30 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 21 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinxin Clinical Project Manager (+86 13885383954, trade@beletalent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in best corrected visual acuity (BCVA) from baseline after 24 weeks of medication; (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2025.