Phase 3 Study of TNTL for Treating Non-Proliferative Diabetic Retinopathy in Adults with Specific Traditional Chinese Medicine Symptoms

What this Trial Is About

Researchers are evaluating the drug TNTL to treat adults with non-proliferative diabetic retinopathy, a condition related to diabetes that affects the eyes. This Phase III clinical study aims to find out if TNTL can improve vision and reduce the severity of retinopathy compared to a placebo. It also assesses the safety of TNTL for participants with this eye condition and specific traditional Chinese medicine syndromes. Participants are randomly assigned to receive either TNTL or a placebo, taking 4 tablets orally three times a day after meals for 24 weeks. The study includes a double-blind design where neither participants nor researchers know who receives the drug or placebo. Visits to the clinic occur every 4 weeks for checkups and testing throughout the 6-month treatment. During the study, participants will have their vision measured using the best corrected visual acuity BCVA test at multiple time points, along with eye exams including retina imaging and optical coherence tomography. Blood tests will monitor blood sugar control and safety indicators. Participants will keep a diary to track symptoms and changes. Safety and effectiveness are closely observed throughout the treatment period.

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