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 @ 2:10 PM
Ignite Modification Date:
2025-12-24 @ 2:10 PM
NCT ID:
NCT02581995
Eligibility Criteria:
Inclusion Criteria:
* Type 1 or 2 diabetes mellitus
* Diagnosis of DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield on OCT) in the study eye
* Decrease in vision determined to be primarily the result of DME in the study eye
* BCVA in the study eye of ETDRS letter score 73 to 24 (This corresponds to a Snellen equivalent of approximately 20/40 to 20/320.)
Exclusion Criteria:
* Pregnancy and lactation
* Mismatch with inclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02581995
Study Brief:
Protocol Section:
NCT02581995