Iluvien Registry Safety Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

559 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No