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Study of Natural Course Progression of Diabetic Retinopathy

Observational Cohort Study of Natural Course Progression of Diabetic Retinopathy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06269419
Enrollment
200
Registered
2024-02-21
Start date
2024-02-25
Completion date
2029-01-01
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarkers of Diabetic Retinopathy

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.

Interventions

None listed

Sponsors

Jie Li
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Observation and follow-up of biomarkers of diabetic retinopathy2024-2029The 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.
Level of Glycosylated hemoglobin2024-2029tested by venous blood
Creatinine2024-2029tested by venous blood
Total cholesterol2024-2029tested by venous blood
Urinary microalbumin2024-2029tested by urine
Urea2024-2029tested by venous blood
Glomerular filtration rate2024-2029tested by venous blood
Triglycerides2024-2029tested by venous blood
Low-density lipoprotein cholesterol2024-2029tested by venous blood
High-density lipoprotein cholesterol2024-2029tested by venous blood
Urinary creatinine ACR2024-2029tested by urine

Countries

China

Contacts

Primary ContactJie Li, doctor
lijieyk@med.uestc.edu.cn+86 13908094675

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026