Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy (TNTL)

August 22, 2025 updated by: Beletalent (Zhuhai) Pharmaceutical Co., Ltd

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:

  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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Xuancheng, Anhui, China, 242000
        • Recruiting
        • Xuancheng People's Hospital
        • Contact:
        • Principal Investigator:
          • Shenghua Dong
    • Beijing
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital
        • Contact:
        • Principal Investigator:
          • Yong Tao
    • Guangdong
      • Guangzhou, Guangdong, China, 510405
        • Recruiting
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Principal Investigator:
          • Hong Liu
        • Contact:
      • Shenzhen, Guangdong, China, 518040
        • Recruiting
        • Shenzhen Eye Hospital
        • Contact:
        • Principal Investigator:
          • Wei Chi
      • Zhuhai, Guangdong, China, 519099
        • Recruiting
        • Zhuhai People's Hospital
        • Contact:
        • Principal Investigator:
          • Hongyun Lu
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Hongpei Ji
      • Guiyang, Guizhou, China, 550001
        • Recruiting
        • The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Limin Wang
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Recruiting
        • Shijiazhuang People's Hospital
        • Contact:
        • Principal Investigator:
          • Qian Ren
    • Henan
      • Kaifeng, Henan, China, 475000
        • Recruiting
        • Kaifeng Central Hospital
        • Contact:
        • Principal Investigator:
          • Hongmei Mu
      • Luoyang, Henan, China, 471099
        • Recruiting
        • Luoyang Third People's Hospital
        • Contact:
        • Principal Investigator:
          • Jingbo Li
      • Xinxiang, Henan, China, 453001
        • Recruiting
        • Xinxiang Central Hospital
        • Contact:
        • Principal Investigator:
          • Ximin Feng
      • Zhengzhou, Henan, China, 450015
        • Recruiting
        • Zhengzhou Second Hospital
        • Contact:
        • Principal Investigator:
          • Xuexia Gao
      • Zhengzhou, Henan, China, 450014
        • Recruiting
        • People's Hospital of Zhengzhou
        • Contact:
        • Principal Investigator:
          • Yuanyuan Yan
    • Hubei
      • Shiyan, Hubei, China, 442099
        • Recruiting
        • Taihe Hospital （Affiliated Hospital Of Hubei University Of Medicine）
        • Principal Investigator:
          • Yong Zhang
        • Contact:
      • Wuhan, Hubei, China, 430080
        • Recruiting
        • Wuhan Puren Hospital
        • Contact:
        • Principal Investigator:
          • Yumin Gui
      • Yichang, Hubei, China, 443000
        • Recruiting
        • Yichang Central People's Hospital
        • Principal Investigator:
          • Yan Zhang
        • Contact:
    • Hunan
      • Hengyang, Hunan, China, 421001
        • Recruiting
        • The First Affiliated Hospital of University of South China
        • Contact:
        • Principal Investigator:
          • Gang Tan
    • Jiangsu
      • Wuxi, Jiangsu, China, 214023
        • Recruiting
        • Wuxi People's Hospital
        • Contact:
        • Principal Investigator:
          • Yong Yao
    • Liaoning
      • Dalian, Liaoning, China, 116001
        • Recruiting
        • Affiliated Zhongshan Hospital Dalian University
        • Principal Investigator:
          • Wei Duan
        • Contact:
        • Principal Investigator:
          • Qian Yang
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Luxin Ma
      • Jinan, Shandong, China, 250011
        • Recruiting
        • Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
        • Contact:
        • Principal Investigator:
          • Hongsheng Bi
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Shandong University of Traditional Chinese Medicine Affiliated Hospital
        • Contact:
        • Principal Investigator:
          • Meirong Chen
      • Jinan, Shandong, China, 250022
        • Recruiting
        • Shandong Second Provincial General Hospital
        • Principal Investigator:
          • Hong Wang
        • Contact:
      • Liaocheng, Shandong, China, 252000
        • Recruiting
        • Liaocheng People's Hospital
        • Contact:
        • Principal Investigator:
          • Xinying You
    • Shanxi
      • Xi'an, Shanxi, China, 710077
        • Recruiting
        • The First Affiliated Hospital of Xi'an Medical University
        • Contact:
        • Principal Investigator:
          • Ying Deng
      • Xi'an, Shanxi, China, 710002
        • Recruiting
        • Xian No.1 Hospital
        • Contact:
        • Principal Investigator:
          • Huiqin Lu
      • Xianyang, Shanxi, China, 712000
        • Recruiting
        • The First People'S Hospitalof Xian Yang
        • Contact:
        • Principal Investigator:
          • Lihua Hou
    • Sichuang
      • Luzhou, Sichuang, China, 646099
        • Recruiting
        • The affiliated hospital of Southwest Medical University
        • Contact:
        • Principal Investigator:
          • Hongshan Lv
      • Panzhihua, Sichuang, China, 617000
        • Recruiting
        • Panzhihua Integrated Traditional Chinese and Western Medicine Hospital
        • Contact:
        • Principal Investigator:
          • Libin Zhou
    • Yunnan
      • Kunming, Yunnan, China, 650021
        • Recruiting
        • Yunnan University Affiliated Hospital
        • Principal Investigator:
          • Min Wu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TNTL Experimental Group
TNTL, oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
Drug: TNTL
oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
Placebo Comparator: TNTL Control Group
TNTL simulation preparation，oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
Drug: TNTL simulation preparation
oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
From enrollment to the end of treatment at 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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;
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.
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.
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
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
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
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
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 fundus condition compared to baseline after 12 and 24 weeks of medication
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 retinal macular optical coherence tomography(OCT) after 12 and 24 weeks of medication compared to baseline
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 HemoglobinA1c levels compared to baseline after 12 and 24 weeks of medication
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
Changes in fasting blood glucose levels after 4, 8, 12, 16, 20, and 24 weeks of medication compared to baseline
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
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.
From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events and reactions
Time Frame: From enrollment to the end of treatment at 24 weeks
Record adverse events, including number of participants with abnormal vital signs,urine analysis, urinalysis,liver function , etc
From enrollment to the end of treatment at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beletalent (Zhuhai) Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: Hongsheng Bi, Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNTL-DR-20241112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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