Study identification

EU PAS number

EUPAS15411

Study ID

41077

Official title and acronym

An open label, registry study of the safety of ILUVIEN® 190 micrograms intravitreal implant in applicator (IRISS)

DARWIN EU® study

No

Study countries

Germany
Portugal
United Kingdom

Study description

This study will assess the safety in patients treated with ILUVIEN. The specific objectives include the study of known safety risks of cataract formation or progression, increased intraocular pressure (both within 30 minutes post-treatment and long-term), changes in intraocular pressure and development of glaucoma, procedural complications such as endophthalmitis, retinal tears, retinal detachments, vitreous haemorrhage or vitreous detachments. Potential safety risks that have not been observed in clinical trials will also be monitored such as, retinitis secondary to reactivation of latent viral infections or other ophthalmic infections, potential systemic events associated with the use of corticosteroids or haemorrhagic events associated with the concurrent therapy with anticoagulant medications. Unknown safety risks will be captured as well. Information on significant retinal ischaemia, removal of the implant, long-term safety data, and repeat use will be evaluated. An evaluation of safety in patients who have received ILUVIEN in both eyes during the study will also be performed. Any use in paediatric patients, pregnant or lactating women and off-label use for other retinal oedema conditions will be reported. It should be understood that the sponsor does not advocate the use of ILUVIEN for any indication other than that which is specified on the Summary of Product Characteristics. However, it is also known that, in clinical practice with marketed products, off-label use is common. Therefore, the sponsor intends to collect safety data for any patient treated with ILUVIEN. Finally, the effect of ILUVIEN on visual acuity will be examined.

Study status

Finalised
Research institutions and networks

Institutions

Networks

CRN NIHR

Contact details

Usha Chakravarthy

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Alimera Sciences Limited
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 1 (imposed as condition of marketing authorisation)