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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 360 (estimated) |
| Sponsor | Beletalent (Zhuhai) Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 30 sites (Xuancheng, Anhui and 29 other locations) |
| Status | Recruiting |
| Started | April 29, 2025 |
| Main results expected | August 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 24, 2025 |
| Trial ID | NCT06817265 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
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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
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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.
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ANXV (Annexin A5) infusions for non-proliferative diabetic retinopathy and retinal vein occlusion
This will test whether short daily infusions of ANXV can be given safely and help improve vision or reduce the need for rescue medication in adults with recent-onset non-proliferative diabetic retinopathy or retinal vein occlusion.
-
OTX-TKI (axitinib intravitreal implant) for non-proliferative diabetic retinopathy
This trial will test whether a long-acting axitinib hydrogel implant injected into one eye can slow worsening in adults with moderately severe to severe non-proliferative diabetic retinopathy.
-
Remote ischemic conditioning to treat early diabetic retinopathy
This trial will test whether remote ischemic conditioning — brief, repeated arm cuff inflations — helps adults aged 40–80 with mild-to-moderate non-proliferative diabetic retinopathy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.