Iluvien Registry Safety Study
- Conditions
- Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies
- Registration Number
- NCT01998412
- Lead Sponsor
- Alimera Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 559
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:
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with adverse events. 5 years
- Secondary Outcome Measures
Name Time Method