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 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
NCT ID:
NCT04991350
Eligibility Criteria:
Inclusion Criteria:
1. Patients ≥18 years old with type 1 or 2 diabetes mellitus with decreased BCVA due to center involving diabetic macular edema on spectral-domain optical coherence tomography.
2. Patients with central macular thickness "CMT" of ≥ 300 micrometers
Exclusion Criteria:
1. Ocular conditions that may affect macular perfusion (e.g. retinal vascular diseases, uveitis, vasculitis etc.)
2. History of vitreo-retinal surgeries.
3. Previous macular laser treatment
4. Presence of epi-retinal membrane involving the macula or vitreo-macular traction.
5. Media opacity preventing good image quality.
6. Uncontrolled glaucoma.
7. Thrombo-embolic events within 6 months
8. Previous intravitreal injections of anti-VEGF
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04991350
Study Brief:
Protocol Section:
NCT04991350