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ClinicalTrials.gov Identifier: NCT01998412
Recruitment Status : Unknown
Verified March 2019 by Alimera Sciences. Recruitment status was: Active, not recruiting
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.
Condition or disease
Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with vision impairment associated with chronic diabetic macular oedema considered insufficiently responsive to available therapies that were selected to be treated with an intravitreal implant of ILUVIEN.
Any patient treated with Iluvien under this protocol will be included in the study.
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.