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:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT04627402
Eligibility Criteria:
Inclusion Criteria:
* Type II diabetes
* Vison decrease was mainly caused by diabetic macular edema (DME)
* BCVA of 20/800 to 20/40 (decimal)
* Central subfield retinal thickness (CST) ≥ 300μm by optical coherence tomography (OCT) in the study eye
* Pan-retinal photocoagulation finished at least 3 months ago, or no pan-retinal photocoagulation is expected in the next 6 months
* Within the last 3 months, one intravitreous injection of anti-VEGF agent was performed, the CST reduction one month after injection was ≤ 20%.
Exclusion Criteria:
* Non-DME related macular edema, or edema control would not benefit the vision (for example, macular atrophy)
* Exist of other reasons of macular edema, retinal vein occlusion, uveitis, iris rubeosis, high myopia
* Ocular media opacity of insufficient quality to obtain OCT images and fundus images in the study eye
* Intraocular or periorbital injection of steroids within the last 3 months
* Macular grid photocoagulation within the last 4 months
* History of vitrectomy
* History of scleral buckle within the last 4 months, or intraocular surgery is expected in the next 6 months
* Any sign of ocular infection, including conjunctivitis, hordeolum, dacryocystitis
* Myocardial infarction, heart failure, stroke, or transient ischemic attack within one month
* Pregnant or breastfeeding women
* Uncontrolled hypertension, or blood pressure \>180/110
* Patients with uncontrolled hyperglycemia, or Hemoglobin A1C (HbA1c) ≥10.0%, or under hemodialysis , or started insulin usage within the last 4 months, or expected to start insulin use for hyperglycemia control in the next 4 months
* Those cannot follow visits on time
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04627402
Study Brief:
Protocol Section:
NCT04627402