Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy

NCT05007262 | Unknown Phase 2

• 1 other identifier: TNTL-21-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 13

Brief Summary

This trial is planned to collect relevant clinical data to evaluate the prevention efficacy and safety of Tangningtongluo tablets on the non-proliferation period of diabetic retinopathy.

Conditions

Type2 Diabetes; Diabetic Retinopathy

Keywords

Diabetes; Retinopathy; Tangningtongluo tablets

Outcome Measures

Primary Outcomes (2)

• Best corrected vision acuity (BCVA)

  using ETDRS vision chart measure vision change from Baseline

  At 24 weeks

• diabetic retinopathy(DR)progression rate

  Using ETDRS Classification to evaluate DR Progress rate

  At 24 weeks

Secondary Outcomes (6)

• Fundus photography

  At 12, 24weeks

• Retinal blood oxygen saturation

  At 12, 24weeks

• Retinal macular optical coherence tomography angiography (OCTA)

  At 12, 24weeks

• HbA1c

  At 12,24,36 and 48 weeks

• Routine eye examination;

  At 4,8,12, 24,36 and 48 weeks

Study Arms (2)

Tangningtongluo tablets

EXPERIMENTAL

Tangningtongluo tablets, 4 tablets one time,tid,po, taken after meals.The patients will receive drugs for 24 weeks continuously. After 24 weeks, the researchers will decide whether to continue depend on the patient condition and willingness. The maximum medication time is up to 48 weeks.Basic treatment: According to the comprehensive objectives of China Type 2 Diabetes Guidelines (2020 Edition) .The Angiotensin-Converting Enzyme（ACEI） and Angiotensin Receptor Blocker（ARB） drugs will be continued to use as the original treatment protocol.

Drug: Tangningtongluo tablets

Calcium dobesilate capsules

ACTIVE COMPARATOR

Calcium dobesilate capsules, 1 capsule at a time, tid,po.(morning, midday, and evening), used on an empty stomach.After 24 weeks, the researchers will decide whether to continue depend on the patient condition and willingness. The maximum medication time is up to 48 weeks.Basic treatment: According to the comprehensive objectives of China Type 2 Diabetes Guidelines (2020 Edition) .The Angiotensin-Converting Enzyme（ACEI ）and Angiotensin Receptor Blocker （ARB） drugs will be continued to use as the original treatment protocol.

Drug: Calcium dobesilate capsules

Interventions

Tangningtongluo tablets DRUG

Four pills each time and three times a day after meals.

Tangningtongluo tablets

Calcium dobesilate capsules DRUG

1 capsule at a time, tid,po.(morning, midday, and evening), used on an empty stomach.

Calcium dobesilate capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with the diagnosis of type 2 diabetes.
• \. Patients with the diagnosis of non-proliferative diabetic retinopathy and the classified as mild and moderate.
• \. Target eye best corrected vision acuity (BCVA) ≥ 34 points (ETDRS vision chart, vision equivalent of score 20 / 200, decimal 0.1).
• \. Patients who meet the syndrome differentiation standards of yin asthenia generating intrinsic heat and eye collateral stasis in traditional Chinese medicine.
• \. HbA1C ≤ 9%.
• \. Age between 18 and 75 years old
• \. Informed consent, voluntary subject. The process of obtaining informed consent form complies with Good Clinical Practice(GCP).

You may not qualify if:

• \. Patient with the diagnosis of diabetic retinopathy is combined with severe vitreous blood effusion, or required total retinal laser treatment or vitrectomy.
• \. Patient who has been treated with full retinal laser photocoagulation.
• \. Patient with difficulty in evaluating fundus images with refractive medium turbidity.
• \. Patient was diagnosed of acute metabolic disorders such as diabetic ketoacidosis or combined with severe acute infection in the past 1 month.
• \. Patient with other serious diabetes complications, such as diabetes gangrene.
• \. Patient was allergic to Tangningtongluo tablets, or Calcium dobesilate, or its composition.
• \. Female patient with pregnancy, or prepare for pregnancy, or lactating.
• \. Patient with serious cardiovascular, liver, kidney or hematopoietic system disease, and mental diseases.
• \. Liver and renal function (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 x Upper limit of normal (ULN)and Cr\> above 1 x Upper limit of normal (ULN)). The diabetic nephropathy stage was 4 and above.
• \. Patient with eye diseases such as glaucoma, uveitis, optic neuropathy, and severe cataract.
• \. Patient participated in other clinical researches within a month.

Sponsors & Collaborators

• Guizhou Bailing Group Pharmaceutical Co Ltd: lead

Study Sites (13)

Chongqing hospital of traditional Chinese Medicine

Chongqing, Chongqing Municipality, 400011, China

Location

Gansu Provincial Hospital of traditional Chinese Medicine

Lanzhou, Gansu, 730050, China

Location

People's Hospital of Anshun City Guizhou Province

Anshun, Guizhou, 561099, China

Location

The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine

Guiyang, Guizhou, 550003, China

Location

Hebei Provincial Hospital of traditional Chinese Medicine

Shijiazhuang, Hebei, 050013, China

Location

The First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410021, China

Location

Inner Mongolia Hospital of traditional Chinese Medicine

Hohhot, Inner Mongolia, 750306, China

Location

Affiliated Hospital of Nantong University

Nantong, Jiangshu, 226006, China

Location

Yangzhou Hospital of traditional Chinese Medicine

Yangzhou, Jiangshu, 225012, China

Location

Ineye Hospital of Chendu University of TCM

Chengdu, Sichuan, China

Location

Banan Hospital Affiliated to Chongqing Medical University

Chongqing, Sichuan, China

Location

South Central Hospital of Yunnan Province

Honghe Prefecture, Yunnan, China

Location

Eye Hospital of WMU

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus; Retinal Diseases

Interventions

tangningtongluo; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Junguo Duan, professor

  Ineye Hospital of Chendu University of TCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 16, 2021
• Study Start: August 31, 2021
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)