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Follows how diabetic eye damage develops in people with type 2 diabetes

Observes how retina blood-flow loss develops in adults with type 2 diabetes over time.

Plain-language title generated from the registry record
Registry title: Study of Natural Course Progression of Diabetic Retinopathy

Key facts

Where
Chengdu, ChinaSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes and mild diabetic eye disease. They will have eye and blood checks for 5 years.

Age
18 to 75 years
Sex
All sexes
Disease stage
Type 2 diabetes. Diabetic retinopathy lesions are less severe than severe NPDR on the eye exam and Optos photo. No diabetic macular edema.
Earlier treatment
No eye laser treatment, and none expected within 6 months. No injection into the eye, and none expected in the next 6 months. No eye surgery.

Main reasons for not taking part

  • Kidney failure
  • Anti-VEGF therapy in the last month
  • Other eye diseases that cause new retinal blood vessels
  • Cloudy eye media that blocks fundus images
  • Traction retinal detachment

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT06269419, who can take part

Where in China

  • Sichuan Academy of Medical Science Sichuan Provincial HosptialChengdu, ChinaContact: Jie Li, doctorTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Jie Li
Trial code
NCT06269419
Record updated
12 March 2024
Original description
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.Read full original descriptionShow less

Observational Cohort Study of Natural Course Progression of Diabetic Retinopathy

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.

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

ClinicalTrials.gov NCT06269419