IRISS registry safety study offers framework for real-world DME outcomes


Fluocinolone acetonide implant for DME benefits visual acuity

real-world outcomes for DME

This article was reviewed by Ramin Khoramnia, MD.

The fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences) maintained good real-world visual levels in patients with dia­betic macular edema (DME) who had good base­line vision.

The open-label, observational Ilu­vien Registry Safety Study (IRISS)1 (NCT01998412) collected real-world data on the safety and efficacy of the 0.2 μg/day of fluocinolone ace­tonide implant for treating chronic DME, defined as recurrent DME that was insufficiently response to available therapies.

The DME had been present for a mean of 4.95 years. The patients were followed from the time of implantation of the device to 3 years postoperatively, according to Ramin Khoramnia, MD, of the Univer­sity Eye Clinic Heidelberg, David J. Apple International Laboratory for Ocular Pathol­ogy, in Heidelberg, Germany.

A total of 295 patients (343 eyes; mean age, 66.3 years) were included in the study at 41 European sites. The mean baseline visual acuity (VA) was about 52 Early Treatment Diabetic Retinopathy Study letters. Most eyes (97.7%) had under­gone laser or intravitreal treatment. Patients have had an insufficient response to previous therapies before being treated with the (Iluvien) implant—that is, they had been treated according to the licensed indication in Europe.

“Regarding supplemental therapies, 51.3% of Ilu­vien-treated eyes that had not optimally responded to previous therapy received no additional treatments during the 36 months,” Khoramnia said. “This fact is particularly interesting because previous treat­ments had been suboptimal in terms of outcomes.

During the 36-month study period, a mean of about 7.4 supplemental treatments were given; 11.1% of patients received a second implant after about 2.8 years following implantation, Khoramnia noted.

36-month DME data

“The intraocular pressure [IOP] remained stable throughout the study and was in the normal range at every time point at which the patients were evaluated,” he said.

About 40% of patients had IOP ele­vations that were managed medically; a surgical intervention was required to lower the IOP in 3.2% of eyes.

Stable/improved vision

Regarding VA outcomes, the VA required to drive (20/40) improved in 18.2% of eyes at baseline to 33.0% at 12 months and this level remained stable until the 36-month time point. In almost three-quarters of eyes (≥71%), the VA remained stable or improved over the 36 months. In eyes in which the baseline VA exceeded 20/40, the VA did not change significantly from baseline at any visit during the 3-year follow-up.

Iluvien DME data study

Khoramnia concluded that for patients complet­ing 3 years of follow-up, the real-life outcomes con­firm the long-term safety and effectiveness of the implant for treating DME in a cohort of patients larger than the European Union registration trial population. The results from clinical practice show changes in IOP and VA similar to those in the pivotal FAME trials.1,2

“It is important to mention that real-world studies, especially those of DME, rarely confirm the good outcomes of the pivotal trials,” he said. “The data also showed that earlier treatment of DME in patients with better vision before the onset of substantial visual impairment stabilized vision for 3 years.”


  1. Chakravarthy U, Taylor SR, Koch FHJ; 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;103(8):1072–1077. doi:10.1136/bjophthalmol-2018-312284
  2. Campochiaro PA, Brown DM, Pearson A, et al; FAME Study Group. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology. 2012;119(10):2125-2132. doi:10.1016/j. ophtha.2012.04.03
Ramin Khoramnia, MD
This article is adapted from Khoramnia’s presentation at the American Academy of Ophthalmology’s virtual 2020 annual meeting. He is a researcher for Alimera Sciences and receives lecture fees from the company.

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