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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT02366468
Eligibility Criteria:
Inclusion Criteria:
* Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0%
* Patients with visual impairment due to DME in at least one eye
* BCVA ≥ 24 and ≤ 78 letters in the study eye
Exclusion Criteria:
* Active intraocular inflammation
* Any active infection in either eye at the
* Structural damage within 0.5 disc diameter of the center of the macula in the study eye
* Uncontrolled glaucoma in either eye at screening
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02366468
Study Brief:
Protocol Section:
NCT02366468