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
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;
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;
Parallel
TNTL
Drugoral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
TNTL simulation preparation
Drugoral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
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;
Change in best corrected visual acuity (BCVA) from baseline after medication
After 4 weeks,8weeks,12weeks,16weeks,20weeks of medication, the subjects' best corrected visual acuity (BCVA) was checked separately and compared with the value measured at week 0 to observe the degree of change from baseline value;
The change and progression rate of ETDRS classification DR Classification from baseline after 12 and 24 weeks of medication;
After 12 weeks，24 weeks of medication, the subjects' ETDRS classification based on the Diabetic Retinopathy Severity Score and compared with the value measured at week 0 to observe the change and progression rate from baseline value as required, with a minimum score of 10 and a maximum score of 90. The higher the score, the more severe it is.
The proportion of subjects whose best corrected visual acuity (BCVA)increased by ≥ 5, ≥ 10, ≥ 15 compared to baseline after medication;
After 4,8,12,16,20,24 weeks of medication, count the proportion of subjects whose best corrected visual acuity(BCVA) increased by ≥ 5, ≥ 10, ≥ 15 compared to baseline
The proportion of subjects whose best corrected visual acuity (BCVA) decreased by ≥ 5, ≥ 10, ≥ 15 compared to baseline after medication
After 4,8,12,16,20,24 weeks of medication, count the proportion of subjects whose best corrected visual acuity(BCVA) decreased by ≥ 5, ≥ 10, ≥ 15 compared to baseline
Adverse events and reactions
Record adverse events, including number of participants with abnormal vital signs,urine analysis, urinalysis,liver function , etc
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