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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT01998412
Eligibility Criteria:
Inclusion Criteria:
* Any patient treated with Iluvien under this protocol will be included in the study.
Exclusion Criteria:
* Patients/Guardians who are unable to understand and sign the Informed Consent will be excluded from the study.
Retrospective Enrollment Criteria
Patients treated with ILUVIEN prior to study initiation may be included provided they satisfy the inclusion and exclusion criteria, where applicable, as well as, the following requirements:
1. The site is allowed to enroll a patient who was treated with ILUVIEN no more than 36 months prior to bringing the patient in for their first study visit.
2. The eligible patient must meet the data requirements as specified in the protocol, i.e., baseline data collected within 7 days prior to treatment with ILUVIEN and additional data subsequently collected approximately every 6 months thereafter until enrolment into the study.
3. The eligible patient must be enrolled at least one year prior to the planned end of the study.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01998412
Study Brief:
Protocol Section:
NCT01998412