Author: Ramin Khoramnia
Co-authors: Tunde Peto, Frank Koch, Simon Taylor, Joao Castro de Sousa, Lauren Hill, Clare Bailey, Usha Chakravarthy
Abstract
PurposeTo describe the intraocular pressure (IOP) and visual acuity (VA) outcomes in patients with chronic diabetic macular edema (cDME) treated with a fluocinolone acetonide (FAc; ILUVIEN) implant by duration of DME.
Setting/Venue
A European, multicentre, open-label, observational registry study of patients treated with the FAc implant for any reason and enrolled from 31 sites in the United Kingdom, 11 in Germany and 5 in Portugal.
Methods
Patients treated with a FAc implant (2013-2017) were included and monitored until the last patient reached ≥3 years of follow-up. Study parameters included: mean IOP, IOP events (i.e., a change in pressure from baseline of ≥10 mmHg and a rise to >30 mmHg), the use of IOP-lowering therapy, changes in mean VA and use of supplemental therapy.
The present analysis describes (1) the long-term safety outcomes and VA changes in the full cohort of patients (695 eyes with a mean follow-up of 37.8 months [up to a maximum of 65.0 months]); and (2) a subgroup analysis comparing IOP and VA outcomes (n=672) by median duration of DME (3.6 years calculated from the record of DME duration captured on the electronic CRF. Participants with a cDME duration ≤3.6 years (n=319) were classified as ‘short-term’, and those with a duration of >3.6 years (n=322) as ‘long-term.’
Results
Full cohort
34.5% of eyes required IOP-lowering medication and the mean time to first IOP-lowering medication was 13.3±11.6 months (mean±SD). 5.5% of eyes required IOP-lowering procedures (4.32% surgical and 1.15% trabeculoplasty) to control pressure and the mean time to first procedure was 25.9±10.6 months. A change in pressure from baseline of ≥10 mmHg and a rise to >30 mm Hg were observed in 15.0% and 14.4% eyes, respectively.
Following FAc implantation, VA improved relative to baseline (52.2±19.1 letters) at all timepoints through to Month 48. Between years 1 and 4, the highest mean value of VA was recorded at Month 36 (57.1±18.9 letters).
Subgroup analysis
Over 36 months, eyes with short-term cDME had a marginally lower frequency of IOP-related events compared with eyes with long-term cDME.
For changes in mean VA at Month 36, eyes in the short-term cDME group experienced a higher sustained improvement (+6.6 letters from a baseline of 52.9 letters) than those in the long-term cDME group (+1.8 letters from a baseline of 51.6 letters). By Month 48, the mean improvement in VA (+7.5 letters from baseline) was still evident in the short-term cDME group, whereas the long-term cDME group lost letters (-1.9 letters from baseline).
Conclusion
The present analysis from the IRISS safety registry is the longest and largest real-world study to date on the outcomes of FAc implantation in European clinical practice. This cohort of patients had a suboptimal response to previous therapies and following treatment with the FAc implant no new or unexpected safety signals were identified, and therapy was associated with clinically meaningfully improvements in VA. Visual benefits were particularly evident in eyes with short-term cDME prior to treatment, suggesting a positive benefit-to-risk profile in patients treated earlier with the FAc implant.
Financial disclosures
RK – reports grants from Chengdu Kanghong; grants, personal fees, and nonfinancial support from Alimera, Bayer, Novartis and Roche, personal fees, and nonfinancial support from Allergan outside the submitted work.
TP - speaker honoraria and advisory board member from Alimera Sciences, Allergan, Bayer, Novartis, Boehringer-Ingelheim and Roche.
FHJK - reports a commercial relationship with Alimera Sciences.
SRT - reports financial relationships with GlaxoSmithKline and Novartis, and speaker honoraria, advisory boards and travel grants from Alimera Sciences, Allergan, Bayer, GlaxoSmithKline, Novartis and Santen.
JPCdS - reports financial support from Alcon, Alimera Sciences and Novartis.
LH – statistical consultant to Genentech, Recens Medical, Polyphotonix, and Alimera Sciences.
CB - advisory board member for Alimera Sciences, Bayer Novartis, Roche, Janssen, Boehringer-Ingelheim
UC - a speaker and advisory board member for Alimera Sciences, an advisory board member for Allergan, Bayer, Novartis and Roche, and has received grants from Bayer, Novartis and Roche.
