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

NCT06817265 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-08-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Beletalent (Zhuhai) Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Hongsheng Bi · Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-29
Primary Completion
2026-08-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06817265 on ClinicalTrials.gov