June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Real-world data from patients with chronic diabetic macular edema and non-infectious uveitis related edema treated with intravitreal fluocinolone acetonide
Author Affiliations & Notes
  • Antonio Bergua
    Ophthalmology, Friedrich-Alexander-Universitat Erlangen-Nurnberg, Erlangen, Bayern, Germany
  • Bettina Hohberger
    Ophthalmology, Friedrich-Alexander-Universitat Erlangen-Nurnberg, Erlangen, Bayern, Germany
  • Melany Roger
    Alimera Sciences Ltd, Berlin, Germany
  • Footnotes
    Commercial Relationships   Antonio Bergua Alimera, Code F (Financial Support); Bettina Hohberger None; Melany Roger Alimera, Code E (Employment)
  • Footnotes
    Support  none
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 551. doi:
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      Antonio Bergua, Bettina Hohberger, Melany Roger; Real-world data from patients with chronic diabetic macular edema and non-infectious uveitis related edema treated with intravitreal fluocinolone acetonide. Invest. Ophthalmol. Vis. Sci. 2023;64(8):551.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Chronic macula edema is a common complication of different retinal disorders, e.g. diabetic retinopathy or non-infectious uveitis. Next to anti-VEGF therapy, glucocorticosteroid therapy is the first-line intravitreal treatment. Because patients vary stronger in their medical history, disease retinal manifestation and personal and social conditions, the treatment modality and time burden plays an important role. Thus, the aim of the present study was to assess real-world outcomes achieved with intravitreal fluocinolone acetonide (FA) (Iluvien®, Alimera) in clinical practice at the University Hospital of Erlangen-Nuremberg, in Erlangen, Germany.

Methods : 48 eyes of patients with chronic diabetic macula edema (DME, n=23) and non-infectious uveitis with involvement of the posterior segment (CME) (NIUPS, n=25), were treated with intravitreal ILUVIEN® and retrospectively analyzed. The primary study outcomes were the best-corrected visual acuity (BVCA) and central retinal thickness (CRT) within a follow-up period between 8 and 36 months. The secondary outcome was intraocular pressure (IOP). Main safety measures were IOP increase and cataract formation.

Results : In DME eyes, CRT was significantly reduced by FA: significant reduction was observed at month 6, 9 and 18 (p<0.05, basal 573 μm vs. 343 μm vs. 313 vs. 281 µm, respectively). BCVA remained stable during follow-up (basal: 0.26±0.17; 36 months: 0,20±0.14). No significant change of mean IOP was observed (<21mmHg). In NIUPS eyes, CRT significantly improved from 467 µm at baseline to 312 µm within 3 months (p<0.05), which was sustained until the end of year 3 (p<0.05, 254 µm). In average, BCVA improved to all time-points within 21 months (0.33±0.26 basal vs. 0.54±0.38 at 21 months), however statistics did not reach significance. Mean IOP remained stable and did not exceed 21 mmHg in average, under anti-glaucomatous treatment, if required. In the DME and NIUPS group, cataract surgeries were necessary in 2/5 and 6/9 phakic eyes, respectively.

Conclusions : The real-world study showed that sustained structural improvements and stabilization with some improvement of the BCVA up to 3 years can be achieved with one single intravitreal inyection of fluocinolone acetonide in both, DME and NIUPS patients. The safety profile was well manageable.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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