Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06269419

Study of Natural Course Progression of Diabetic Retinopathy

Led by Jie Li · Updated on 2024-03-12

200

Participants Needed

1

Research Sites

253 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Study of Natural Course Progression of Diabetic Retinopathy

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with type 2 diabetes aged 18 to 75 years
  • Able to cooperate with examinations and sign informed consent
  • No other eye diseases causing retinal neovascularization
  • No significant media haze affecting fundus image quality
  • No history of fundus laser treatment or no laser treatment expected within 6 months
  • No previous intravitreal drug injections and none expected in the next 6 months
  • Macular thickness within specified limits (Zeiss OCT women < 290µm, men < 305µm; Heidelberg OCT women < 305µm, men < 320µm)
  • Diabetic retinopathy lesions less severe than non-proliferative diabetic retinopathy (NPDR) on clinical mydriasis and Optos 7 field imaging
  • No history of eye surgery
Not Eligible

You will not qualify if you...

  • Patients with kidney failure
  • History of systemic anti-VEGF therapy within the last month
  • Follow-up expected to be difficult or patients with traction retinal detachment from other provinces
  • History of allergy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Sichuan Academy of Medical Science Sichuan Provincial Hosptial

Chengdu, Sichuan, China, 610014

Actively Recruiting

Loading map...

Research Team

J

Jie Li, doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here