Iluvien Registry Safety Study (IRISS)

Alimera Sciences

Status: Unknown

Conditions: Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies

Study type: Observational

Funder types: Industry

Identifiers

NCT01998412

M-01-12-001

Details and patient eligibility

About

The study will include any patient treated with Iluvien at designated sites in European countries where marketing authorization has been granted in order to obtain broader safety and usage information.

Enrollment: 559 patients

Sex: All

Volunteers: No Healthy Volunteers

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.