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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT05080803
Eligibility Criteria:
Inclusion Criteria. Eligible eyes at the retrospective review
1. Any stage of DME treated with a loading dose of 3 anti-VEGF (any type) or 1 IV dexamethasone (STEP 1).
2. OCT scans and retinal maps (radial/raster lines) at baseline (max 1 month before injection) and at one month (max 6 weeks) after the third anti-VEGF or at 3 months (max 16 weeks) after IV steroid injection (STEP 2).
3. VA at the time of both OCT examinations.
Exclusion Criteria:
1. Past ocular surgery of any kind (except for cataract surgery) or ocular pathologies other than diabetic retinopathy.
2. Macular edema considered to be due to a cause other than diabetic macular edema.
3. OCT examination suggesting that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema. In the case of ERM, an OCT scan must be sent to the Coordinating Center for approval.
4. Any ocular pathology or ocular condition other than diabetes that in the opinion of the investigator might affect macular edema.
5. History of any therapy (anti-VEGF treatment, focal/grid macular photocoagulation, intravitreous or peribulbar corticosteroids) for DME or diabetic retinopathy in the past 8 months.
6. History of YAG capsulotomy performed within two months before enrollment.
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT05080803
Study Brief:
Protocol Section:
NCT05080803