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

Inclusion Criteria:

• Age range of 18 to 75 years old (including boundary values);

• Conform to the diagnosis of type 2 diabetes and diabetes retinopathy. diabetesretinopathy is classified as NPDR and mild and moderate patients;

• Patients with the best corrected visual acuity (BCVA) of the target eye is ≥ 34points (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, internalheat, 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 informedconsent form.

Exclusion Criteria:

• Patients with no light perception in one eye;

• Patients with macular edema who require anti Vascular Endothelial GrowthFactor(VEGF) treatment;

• People with other eye diseases, such as retinal artery or vein occlusion, nondiabetes retinopathy, retinal detachment, uveitis, glaucoma, corneal ulcer, cataractaffecting 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 oneyear before the screening period;

• People with other eye related complications of diabetes, such as irisneovascularization, angle neovascularization, and retinal neovascularization;

• acupuncture and moxibustion and other external treatment methods of traditionalChinese medicine were used to treat diabetes retinopathy within one week beforeenrollment;

• Patients who have used drugs clearly stated in the instruction manual to treatdiabetes retinopathy, such as calcium dobesilate, pancreatic kallidinogenase, QimingGranules, Shuangdan Mingmu Capsules, Compound Danshen Dropping Pills, Tongluo MingmuCapsules, etc. within 2 weeks before enrollment;

• Patients who have undergone glaucoma, vitreous, retinal and other intraocularsurgeries and procedures in the target eye within 3 months before enrollment;

• Patients who have undergone cataract surgery in the target eye within 3 months priorto enrollment and have not yet stabilized according to the researcher's assessment;

• Patients who have received intravitreal injections of anti VEGF antibodies andglucocorticoids in the target eye within 3 months prior to enrollment;

• Patients who have undergone total retinal laser photocoagulation treatment in thetarget eye;

• For those whose refractive media is turbid and difficult to evaluate fundus imagesin the target eye;

• Uncontrolled or controlled blood pressure with systolic blood pressure ≥ 160mmHgand/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, orthose 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 toconceive; Female subjects of childbearing age or male subjects (with partners ofchildbearing age) who do not agree to voluntarily take effective contraceptivemeasures within one month after the last dose during the screening period;

• Individuals who are allergic to the drugs or their components used in thisexperiment;

• Participants who have participated in other clinical trials within the past month;

• The researchers believe that participants should not participate in the clinicaltrial.