NCT06817265

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Beletalent (Zhuhai) Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non-Proliferative Diabetic Retinopathy

Interventions

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

Timeline

• Start date: 2025-04-29
• Primary completion: 2026-08-30
• Completion: 2026-12-31
• First posted: 2025-02-10
• Last updated: 2025-08-24

Locations

30 sites across 1 country: China