Evaluating TNTL for treating non-proliferative diabetic retinopathy

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)

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
• Enrollment: 360 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beletalent (Zhuhai) Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 30 sites (Xuancheng, Anhui and 29 other locations)
• Trial ID: NCT06817265 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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

Eligibility 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 this trial is running

Xuancheng, Anhui and 29 other locations

• 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)
• 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

Conditions Non-Proliferative Diabetic Retinopathy