Observing the progression of diabetic retinopathy in patients with type 2 diabetes
Observational Cohort Study of Natural Course Progression of Diabetic Retinopathy
This study is tracking how diabetic retinopathy develops in people with type 2 diabetes over five years to see if certain changes in the eye happen sooner and how they might affect the disease's progression.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sichuan Provincial People's Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06269419 on ClinicalTrials.gov |
What this trial studies
This observational study aims to track the development of non-perfusion areas in the retina of type 2 diabetes patients aged 18-75. Participants will undergo follow-up examinations over a period of 5 years to assess the formation and expansion of these areas, which may indicate the progression of diabetic retinopathy. The study will evaluate whether posterior retinal non-perfusion occurs earlier than peripheral non-perfusion and if the rate of expansion serves as a risk factor for disease progression. The study includes detailed assessments of medical history, medications, and eye health.
Who should consider this trial
Good fit: Ideal candidates are type 2 diabetes patients aged 18-75 who can comply with study requirements and have mild to severe non-proliferative diabetic retinopathy.
Not a fit: Patients with kidney failure or those who have undergone recent systemic anti-VEGF therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of diabetic retinopathy progression, leading to improved monitoring and treatment strategies for patients.
How similar studies have performed: While there have been studies on diabetic retinopathy, this specific observational approach focusing on non-perfusion areas is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chengdu, Sichuan
- Sichuan Academy of Medical Science Sichuan Provincial Hosptial — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Jie Li, doctor
- Email: lijieyk@med.uestc.edu.cn
- Phone: +86 13908094675
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.