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

NCT06817265 | Recruiting Phase 3

• 1 other identifier: TNTL-DR-20241112
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 30

Brief 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. 1.Does drug TNTL can improve visual acuity and reduce the degree of retinopathy?
2. 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.
3. 3.Take drug TNTL or a placebo every day for 6 months
4. 4.Visit the clinic once every 4 weeks for checkups and tests
5. 5.Keep a diary of their symptoms and Change from baseline

Conditions

Non-Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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;

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (9)

• Change in best corrected visual acuity (BCVA) from baseline after medication

  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;

  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;

  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

  From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks

• Changes in fundus condition compared to baseline

  From enrollment to the end of treatment at 12 and 24 weeks.

Other Outcomes (1)

• Adverse events and reactions

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

TNTL Experimental Group

ACTIVE COMPARATOR

TNTL, oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.

Drug: TNTL

TNTL Control Group

PLACEBO COMPARATOR

TNTL simulation preparation，oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.

Drug: TNTL simulation preparation

Interventions

TNTL DRUG

oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.

TNTL Experimental Group

TNTL simulation preparation DRUG

oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.

TNTL Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beletalent (Zhuhai) Pharmaceutical Co., Ltd: lead

Study Sites (30)

Xuancheng People's Hospital

Xuancheng, Anhui, 242000, China

RECRUITING

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510405, China

RECRUITING

Shenzhen Eye Hospital

Shenzhen, Guangdong, 518040, China

RECRUITING

Zhuhai People's Hospital

Zhuhai, Guangdong, 519099, China

RECRUITING

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Guiyang, Guizhou, 550001, China

RECRUITING

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550002, China

RECRUITING

Shijiazhuang People's Hospital

Shijiazhuang, Hebei, 050011, China

RECRUITING

Kaifeng Central Hospital

Kaifeng, Henan, 475000, China

RECRUITING

Luoyang Third People's Hospital

Luoyang, Henan, 471099, China

RECRUITING

Xinxiang Central Hospital

Xinxiang, Henan, 453001, China

RECRUITING

People's Hospital of Zhengzhou

Zhengzhou, Henan, 450014, China

RECRUITING

Zhengzhou Second Hospital

Zhengzhou, Henan, 450015, China

RECRUITING

Taihe Hospital （Affiliated Hospital Of Hubei University Of Medicine）

Shiyan, Hubei, 442099, China

RECRUITING

Wuhan Puren Hospital

Wuhan, Hubei, 430080, China

RECRUITING

Yichang Central People's Hospital

Yichang, Hubei, 443000, China

RECRUITING

The First Affiliated Hospital Of University Of South China

Hengyang, Hunan, 421001, China

RECRUITING

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

RECRUITING

Affiliated Zhongshan Hospital Dalian University

Dalian, Liaoning, 116001, China

RECRUITING

Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital

Jinan, Shandong, 250011, China

RECRUITING

Shandong University of Traditional Chinese Medicine Affiliated Hospital

Jinan, Shandong, 250012, China

RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

RECRUITING

Shandong Second Provincial General Hospital

Jinan, Shandong, 250022, China

RECRUITING

Liaocheng People's Hospital

Liaocheng, Shandong, 252000, China

RECRUITING

The First People'S Hospitalof Xian Yang

Xianyang, Shanxi, 712000, China

RECRUITING

Xian No.1 Hospital

Xi’an, Shanxi, 710002, China

RECRUITING

The First Affiliated Hospital of Xi'an Medical University

Xi’an, Shanxi, 710077, China

RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuang, 646099, China

RECRUITING

Panzhihua Integrated Traditional Chinese and Western Medicine Hospital

Panzhihua, Sichuang, 617000, China

RECRUITING

Yunnan University Affiliated Hospital

Kunming, Yunnan, 650021, China

RECRUITING

Study Officials

• Hongsheng Bi

  Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinxin Clinical Project Manager

CONTACT

+86 13885383954; trade@beletalent.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 10, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (30)