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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeletalent (Zhuhai) Pharmaceutical Co., Ltd

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • TNTL
  • TNTL simulation preparation

Treatment groups

360 Participants
are divided into 2 treatment groups