Iluvien Registry Safety Study

Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies Clinical Trial

— IRISS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01998412
• Other study ID #: M-01-12-001
• Status: Active, not recruiting
• Start date: December 2013
• Est. completion date: January 2020

Study information

• Verified date: March 2019
• Source: Alimera Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 559
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies
• Macular Edema

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alimera Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chakravarthy U, Taylor SR, Koch FHJ, Castro de Sousa JP, Bailey C. Changes in intraocular pressure after intravitreal fluocinolone acetonide (ILUVIEN): real-world experience in three European countries. Br J Ophthalmol. 2018 Sep 21. pii: bjophthalmol-2018 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events.		5 years

External Links

•   Changes in intraocular pressure after intravitreal fluocinolone acetonide (ILUVIEN): real-world experience in three European countries