Study of Natural Course Progression of Diabetic Retinopathy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorJie Li

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Type 2 diabetes patients with no diabetic retinopathy
Group B: Type 2 diabetes patients with mild to moderate diabetic non-proliferative retinopathy

Trial outcomes

Primary outcomes

1

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.

Time frame
2024-2029
2

Level of Glycosylated hemoglobin

tested by venous blood

Time frame
2024-2029
3

Creatinine

tested by venous blood

Time frame
2024-2029
4

Total cholesterol

tested by venous blood

Time frame
2024-2029

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jie Li

Lead sponsor

Sichuan Provincial People's Hospital

Sponsor institution