Iluvien Registry Safety Study

Status unconfirmed

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

In brief

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.

Key facts

Study ID

NCT01998412

Run by

Alimera Sciences

People needed

559

Starts

2013-12-01

Expected to finish

2020-01-01

Last updated by the study team

2019-03-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient treated with Iluvien under this protocol will be included in the study.

You may not qualify if…

• 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:
• 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.
• 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.
• The eligible patient must be enrolled at least one year prior to the planned end of the study.

Where it is running

• Study site — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.