Iluvien Registry Safety Study

An Open Label, Registry Study of the Safety of Iluvien® 190 Micrograms Intravitreal Implant in Applicator

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01998412

Acronym

IRISS

Enrollment

559

Registered

2013-11-28

Start date

2013-12-31

Completion date

2020-01-31

Last updated

2019-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events.	5 years

Countries

United States

Outcome results