Clinical trial NCT06817265: Clinical Study on the Efficacy and Safety of TNTL in the Treatment of 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-Proliferative Diabetic Retinopathy
Lead sponsor: Beletalent (Zhuhai) Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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


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.

Primary outcomes:
measure: Change in best corrected visual acuity (BCVA) from baseline after 24 weeks of medication;
timeFrame: From enrollment to the end of treatment at 24 weeks
Secondary outcomes:
measure: Change in best corrected visual acuity (BCVA) from baseline after medication
timeFrame: From enrollment to the end of treatment at 4 weeks,8weeks,12weeks,16weeks,20weeks
measure: The change and progression rate of ETDRS classification DR Classification from baseline after 12 and 24 weeks of medication;
timeFrame: From enrollment to the end of treatment at 12weeks and 24weeks.
measure: The proportion of subjects whose best corrected visual acuity (BCVA)increased by ≥ 5, ≥ 10, ≥ 15 compared to baseline after medication;
timeFrame: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
measure: The proportion of subjects whose best corrected visual acuity (BCVA) decreased by ≥ 5, ≥ 10, ≥ 15 compared to baseline after medication
timeFrame: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
measure: Changes in fundus condition compared to baseline
timeFrame: From enrollment to the end of treatment at 12 and 24 weeks.
measure: Changes in retinal macular optical coherence tomography (OCT) compared to baseline
timeFrame: From enrollment to the end of treatment at 12 and 24 weeks.
measure: Changes in HemoglobinA1c compared to baseline
timeFrame: From enrollment to the end of treatment at 12 and 24 weeks.
measure: Changes in fasting blood glucose compared to baseline
timeFrame: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
measure: Effective rate of traditional Chinese medicine syndrome
timeFrame: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
Other outcomes:
measure: Adverse events and reactions
timeFrame: From enrollment to the end of treatment at 24 weeks
Locations:
city: Xuancheng
country: China
facility: Xuancheng People's Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Eye Hospital
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
state: Guangdong
city: Guiyang
country: China
facility: The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
state: Guizhou
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Shijiazhuang
country: China
facility: Shijiazhuang People's Hospital
state: Hebei
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
state: Henan
city: Luoyang
country: China
facility: Luoyang Third People's Hospital
state: Henan
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: People's Hospital of Zhengzhou
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Second Hospital
state: Henan
city: Shiyan
country: China
facility: Taihe Hospital （Affiliated Hospital Of Hubei University Of Medicine）
state: Hubei
city: Wuhan
country: China
facility: Wuhan Puren Hospital
state: Hubei
city: Hengyang
country: China
facility: The First Affiliated Hospital Of University Of South China
state: Hunan
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital Dalian University
state: Liaoning
city: Jinan
country: China
facility: Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong University of Traditional Chinese Medicine Affiliated Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Second Provincial General Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Xi'an
country: China
facility: Xian No.1 Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shanxi
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuang
city: Panzhihua
country: China
facility: Panzhihua Integrated Traditional Chinese and Western Medicine Hospital
state: Sichuang
city: Kunming
country: China
facility: Yunnan University Affiliated Hospital
state: Yunnan
Study officials:
affiliation: Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
name: Hongsheng Bi
role: PRINCIPAL_INVESTIGATOR
References: