Clinical trial Recruiting at 30 sites Phase 3 Interventional Ages 18 to 75

Evaluating TNTL for treating non-proliferative diabetic retinopathy

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)

Run by Beletalent (Zhuhai) Pharmaceutical Co., Ltd · NCT06817265 · Data updated 2026-11-12

This study is testing if a new drug called TNTL can help adults with non-proliferative diabetic retinopathy see better and stay safe compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment360 (estimated)
SponsorBeletalent (Zhuhai) Pharmaceutical Co., Ltd
Industry-sponsored
Locations30 sites (Xuancheng, Anhui and 29 other locations)
StatusRecruiting
StartedApril 29, 2025
Main results expectedAugust 30, 2026
Study endsDecember 31, 2026
Registry record updatedAugust 24, 2025
Trial IDNCT06817265 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 75 with type 2 diabetes and mild to moderate non-proliferative diabetic retinopathy.

Probably not a fit

Patients with severe eye conditions or those requiring specific treatments for macular edema may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the efficacy and safety of the drug TNTL in adults diagnosed with non-proliferative diabetic retinopathy. Participants will receive either TNTL or a placebo daily for six months, with regular clinic visits every four weeks for checkups and symptom tracking. The study will focus on improvements in visual acuity and the overall safety profile of TNTL compared to a placebo. Researchers will also monitor any medical issues arising during the treatment period.

Why it matters

Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients with non-proliferative diabetic retinopathy.

How similar studies have gone: While this approach is being tested in this specific context, similar studies have shown promise in treating diabetic retinopathy with other interventions.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Xuancheng People's Hospital
    Xuancheng, Anhui, China
    Recruiting
  • Beijing Chaoyang Hospital
    Beijing, Beijing Municipality, China
    Recruiting
  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
    Guangzhou, Guangdong, China
    Recruiting
  • Shenzhen Eye Hospital
    Shenzhen, Guangdong, China
    Recruiting
  • Zhuhai People's Hospital
    Zhuhai, Guangdong, China
    Recruiting
  • The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
    Guiyang, Guizhou, China
    Recruiting
Show 24 more locations
  • Guizhou Provincial People's Hospital
    Guiyang, Guizhou, China
    Recruiting
  • Shijiazhuang People's Hospital
    Shijiazhuang, Hebei, China
    Recruiting
  • Kaifeng Central Hospital
    Kaifeng, Henan, China
    Recruiting
  • Luoyang Third People's Hospital
    Luoyang, Henan, China
    Recruiting
  • Xinxiang Central Hospital
    Xinxiang, Henan, China
    Recruiting
  • People's Hospital of Zhengzhou
    Zhengzhou, Henan, China
    Recruiting
  • Zhengzhou Second Hospital
    Zhengzhou, Henan, China
    Recruiting
  • Taihe Hospital (Affiliated Hospital Of Hubei University Of Medicine)
    Shiyan, Hubei, China
    Recruiting
  • Wuhan Puren Hospital
    Wuhan, Hubei, China
    Recruiting
  • Yichang Central People's Hospital
    Yichang, Hubei, China
    Recruiting
  • The First Affiliated Hospital Of University Of South China
    Hengyang, Hunan, China
    Recruiting
  • Wuxi People's Hospital
    Wuxi, Jiangsu, China
    Recruiting
  • Affiliated Zhongshan Hospital Dalian University
    Dalian, Liaoning, China
    Recruiting
  • Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
    Jinan, Shandong, China
    Recruiting
  • Shandong University of Traditional Chinese Medicine Affiliated Hospital
    Jinan, Shandong, China
    Recruiting
  • Shandong Provincial Hospital
    Jinan, Shandong, China
    Recruiting
  • Shandong Second Provincial General Hospital
    Jinan, Shandong, China
    Recruiting
  • Liaocheng People's Hospital
    Liaocheng, Shandong, China
    Recruiting
  • The First People'S Hospitalof Xian Yang
    Xianyang, Shanxi, China
    Recruiting
  • Xian No.1 Hospital
    Xi’an, Shanxi, China
    Recruiting
  • The First Affiliated Hospital of Xi'an Medical University
    Xi’an, Shanxi, China
    Recruiting
  • The Affiliated Hospital of Southwest Medical University
    Luzhou, Sichuang, China
    Recruiting
  • Panzhihua Integrated Traditional Chinese and Western Medicine Hospital
    Panzhihua, Sichuang, China
    Recruiting
  • Yunnan University Affiliated Hospital
    Kunming, Yunnan, China
    Recruiting

Study contacts

  • Principal investigator: Hongsheng Bi — Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
  • Study coordinator: Jinxin Clinical Project Manager
  • Email: trade@beletalent.com
  • Phone: +86 13885383954

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.