Iluvien Registry Safety Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/22/2019 |
| Start Date: | December 2013 |
| End Date: | January 2020 |
An Open Label, Registry Study of the Safety of Iluvien® 190 Micrograms Intravitreal Implant in Applicator
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.
countries where marketing authorization has been granted in order to obtain broader safety
and usage information.
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.
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