NCT06269419Recruiting
Study of Natural Course Progression of Diabetic Retinopathy
Observational Cohort Study of Natural Course Progression of Diabetic Retinopathy
Source: ClinicalTrials.gov · Last updated 12 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 6 Feb 2024
- Start date
- 25 Feb 2024
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Jie Li
- Diseases
- Diabetic eye disease
- NCT number
- NCT06269419
What you commit to
- Study type: Observational
- Planned participants: 200
- From 25 Feb 2024 to the primary completion date, 1 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with kidney failure.
- History of systemic anti-VEGF therapy within the last month.
- The patient has a history of allergy
Other
- Follow-up is expected to be difficult or patients from other provinces have traction retinal detachment;
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sichuan Academy of Medical Science Sichuan Provincial Hosptial Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.