Iluvien Registry Safety Study
IRISS
An Open Label, Registry Study of the Safety of Iluvien® 190 Micrograms Intravitreal Implant in Applicator
1 other identifier
observational
559
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2013
CompletedFirst Posted
Study publicly available on registry
November 28, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedMarch 20, 2019
March 1, 2019
6.1 years
November 20, 2013
March 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events.
5 years
Eligibility Criteria
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.
You may qualify if:
- Any patient treated with Iluvien under this protocol will be included in the study.
You may not qualify if:
- Patients/Guardians who are unable to understand and sign the Informed Consent will be excluded from the study.
- Retrospective Enrollment Criteria
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alimera Scienceslead
Study Sites (1)
Unknown Facility
Atlanta, Georgia, United States
Related Publications (1)
Chakravarthy U, Taylor SR, Koch FHJ, Castro de Sousa JP, Bailey C; ILUVIEN Registry Safety Study (IRISS) Investigators Group. Changes in intraocular pressure after intravitreal fluocinolone acetonide (ILUVIEN): real-world experience in three European countries. Br J Ophthalmol. 2019 Aug;103(8):1072-1077. doi: 10.1136/bjophthalmol-2018-312284. Epub 2018 Sep 21.
PMID: 30242062RESULT
Related Links
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2013
First Posted
November 28, 2013
Study Start
December 1, 2013
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
March 20, 2019
Record last verified: 2019-03