Study of Natural Course Progression of Diabetic Retinopathy

NCT06269419 | Recruiting

• 1 other identifier: 2023-KY295
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to observe the formation and development of the non-perfusion area of diabetic retinopathy in the posterior area of the retina in type 2 diabetes patients aged 18-75 years old, who can cooperate with all examinations and sign informed consent, clinical myopathy examination and Optos 7 field of vision with mild than severe NPDR, and no other exclusion indicators.The main questions it aims to answer are whether posterior retinal non-perfusion area occurs earlier than peripheral non-perfusion area and whether the rate of non-perfusion area expansion is a risk factor for the progression of diabetic retinopathy. Participants will have protocol-specific follow-up examinations at 1, 2, 3, 4, and 5 years (± 3 months). Additional visits are made as required by the study and the patient's condition. The contents of follow-up examinations are: History of other diseases, medications being used, eye diseases, surgeries, treatments, height, weight, and blood pressure. Best corrected vision, logarithmic visual acuity chart. Tupai OCTA, 24×20mm range, 6×6mm range scan. Optos fundus imaging, color and no red light images. Fundus fluorescence angiography (only preliminary examination for the first time found mild to moderate NPDR patients, who have been angiographed in the past, only at the 5th year, or as required by the condition). Glycosylated hemoglobin. Creatinine, urea, glomerular filtration rate. Total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol. Urinary microalbumin/urinary creatinine ACR. Microvisual field.

Conditions

Biomarkers of Diabetic Retinopathy

Outcome Measures

Primary Outcomes (11)

• Observation and follow-up of biomarkers of diabetic retinopathy

  The biomarkers of diabetic retinopathy were observed by eye examinations including best corrected visual acuity, logarithmic visual acuity chart, TupaOCTA 24×20mm, 6×6mm scan, Optos fundus color and non-red light images, microvisual field at each follow-up.

  2024-2029

• Level of Glycosylated hemoglobin

  tested by venous blood

  2024-2029

• Creatinine

  tested by venous blood

  2024-2029

• Total cholesterol

  tested by venous blood

  2024-2029

• Urinary microalbumin

  tested by urine

  2024-2029

• Urea

  tested by venous blood

  2024-2029

• Glomerular filtration rate

  tested by venous blood

  2024-2029

• Triglycerides

  tested by venous blood

  2024-2029

• Low-density lipoprotein cholesterol

  tested by venous blood

  2024-2029

• High-density lipoprotein cholesterol

  tested by venous blood

  2024-2029

• Urinary creatinine ACR

  tested by urine

  2024-2029

Study Arms (2)

Type 2 diabetes patients with no diabetic retinopathy

Type 2 diabetes patients with mild to moderate diabetic non-proliferative retinopathy

Eligibility Criteria

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

Study Population

Type 2 diabetes patients aged 18-75 years old, who can cooperate with all examinations and sign informed consent, clinical myopathy examination and Optos 7 field of vision with mild than severe NPDR, and no other exclusion indicators.

You may qualify if:

• Patients with type 2 diabetes aged 18-75 years
• Can cooperate with the inspection and sign the informed consent
• There are no other eye diseases that cause retinal neovascularization
• There is no known substantial media haze that would hinder fundus image acquisition
• No history of fundus laser treatment or no possibility of laser treatment expected within six months
• No previous history of intravitreal drug injection, and no intravitreal drug injection is expected in the next 6 months
• Macular edema without diabetes (Zeiss OCT women \< 290µm, male \< 305µm; OCT female in Heidelberg is \< 305µm, and for males \< 320µm)
• In the field of visual field of clinical mydriasis and Optos photo 7 field of view, DR Lesions were less severe than NPDR
• No history of eye surgery

You may not qualify if:

• Patients with kidney failure.
• History of systemic anti-VEGF therapy within the last month.
• Follow-up is expected to be difficult or patients from other provinces have traction retinal detachment;
• The patient has a history of allergy

Sponsors & Collaborators

• Jie Li: lead

Study Sites (1)

Sichuan Academy of Medical Science Sichuan Provincial Hosptial

Chengdu, Sichuan, 610014, China

RECRUITING

Central Study Contacts

Jie Li, doctor

CONTACT

+86 13908094675; lijieyk@med.uestc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 21, 2024
• Study Start: February 25, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2030 and for forever
• Access Criteria: https://pan.baidu.com

Locations

CN (1)