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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT04697758
Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years of age or older with diabetic macular edema (DME) diagnosis secondary to diabetes mellitus Type 1 or 2
* Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 23 in the study eye
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed inform consent
Exclusion Criteria:
* Any signs of high risk proliferative diabetic retinopathy in the study
* Previously-treated patients who are not responders to anti-VEGF
* Panretinal laser photocoagulation within 6 months and macular laser photocoagulation with 3 months of screening in the study eye
Note: Other inclusion/exclusion criteria apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04697758
Study Brief:
Protocol Section:
NCT04697758