Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT05223569
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years;
2. Diagnosis of diabetic macular edema:
* Type 1 or type 2 diabetes mellitus;
* Center-involved macular edema;
3. Willing to receive anti-VEGF treatment;
4. Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT examination;
5. Able to operate self-administratedhome OCT by themselves or with the help of family;
6. Travel time from home to hospital: within 2 hours driving.
7. Able and willing to provide informed consent.
Exclusion Criteria:
1. History of systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization. (These drugs should not be used during the study);
2. History of corticosteroid treatment (intravitreal or peribulbar) at any time in the past 4 months;
3. History of macular laser photocoagulation in the past 4 months;
4. Macular edema due to reasons other than diabetes;
5. Coexisting ocular diseases that might alter visual acuity during the course of the study, such as retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.);
6. Hypertension (systolic blood pressure (BP) above 180 or diastolic BP above 110);
7. History of myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization;
8. Pregnant or lactating;
9. Currently participating in other clinical trials;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05223569
Study Brief:
Protocol Section:
NCT05223569