Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 2025 Oct;39(14):2678-2685.
doi: 10.1038/s41433-025-03929-5. Epub 2025 Jul 21.

Efficacy and safety of multiple fluocinolone acetonide implants in diabetic macular oedema: comparison between first and second intravitreal injections

Yasmine Serrar #  1 , Lucas Sejournet #  1   2 , Victor Thomeret  1 , Corinne Dot  3   4   5 , Sophie Bonnin  6 , Vincent Soler  7 , Laurence Rosier  8 , Frédéric Matonti  9   10   11 , Mariam Ghazaryan  1   12 , Thibaud Mathis  1   2 , Laurent Kodjikian  13   14
Affiliations
Comparative Study

Efficacy and safety of multiple fluocinolone acetonide implants in diabetic macular oedema: comparison between first and second intravitreal injections

Yasmine Serrar et al. Eye (Lond). 2025 Oct.

Abstract

Purpose: To compare the efficacy and safety between a first and a second injection of fluocinolone acetonide implants (FAc-I) in the treatment of diabetic macular oedema (DMO).

Methods: This retrospective, multicentre cohort study included eyes with chronic DMO that received two consecutive FAc-I injections. We analysed visual and anatomical outcomes, additional DMO treatments, and intraocular pressure (IOP)-related adverse events.

Results: We included 61 eyes from 44 patients. Stable or improved BCVA was observed in 100% of eyes after the first injection and in 93% after the second, demonstrating statistical equivalence within a ±15% margin (p = 0.005). Statistical equivalence was also found for the lowest CRT (±10% margin, p < 0.001) and for the proportion of eyes with ≥20% CRT decrease (±20% margin, p = 0.026). The proportion of patients requiring additional treatments during the first year was equivalent between injections (p = 0.036), with a therapeutic burden reduction of 63% and 59%, respectively. Regarding peak IOP, equivalence was observed between the two injections (±5 mmHg margin, p < 0.001). The incidence of OHT was numerically higher after the second injection (19.7% vs 11.5%, p = 0.302), but this difference was not statistically significant.

Conclusion: Multiple FAc-I injections are a safe and effective treatment option for chronic DMO in real life. The second injection maintained similar functional and anatomical outcomes to the first, supporting the sustainability and repeatability of the treatment.

PubMed Disclaimer

Conflict of interest statement

Competing interests: YS, LS, VT and MG have no conflict of interest to report. LK is consultant for Abbvie, Astellas, Bayer, Alimera-Horus, Novartis, Roche and Théa. TM is consultant for Abbvie, Astellas, Bayer, Horus, Novartis and Roche. CD is consultant for Abbvie, Bayer, Horus, Novartis, Roche and Thea. SB is consultant for AbbVie, Bayer, Oculis, Optic 2000, Roche. VS is consultant for Abbvie, Alcon, FCI, Bayer, Cristallens, Horus, Roche, Novartis and Thea. LR is consultant for Abbvie, Bayer, Horus Novartis and Roche. FM is consultant for Abbvie, Bayer, Alimera-Horus, Roche, and Novartis.

Figures

Fig. 1
Fig. 1. Mean change in best-visual acuity (BCVA), central macular thickness (CMT) and intra-ocular pressure (IOP) after first and second fluocinolone-acetonide implant injections (FAc-I).
A Mean change in BCVA. B Mean change in CMT. C Mean change in IOP. BCVA = best corrected visual acuity, CRT central retinal thickness, FAc-I intravitreal fluocinolone acetonide implant, IOP intraocular pressure.
Fig. 2
Fig. 2
Management of IOP-lowering treatment after first and second FAc-I injections.
See this image and copyright information in PMC

References

    1. Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, et al. IDF diabetes atlas: global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022;183:109119. - PMC - PubMed
    1. Bourne RRA, Jonas JB, Bron AM, Cicinelli MV, Das A, Flaxman SR, et al. Prevalence and causes of vision loss in high-income countries and in Eastern and Central Europe in 2015: magnitude, temporal trends and projections. Br J Ophthalmol. 2018;102:575–85. - PMC - PubMed
    1. Schmidt-Erfurth U, Garcia-Arumi J, Bandello F, Berg K, Chakravarthy U, Gerendas BS, et al. Guidelines for the management of diabetic macular edema by the European Society of Retina Specialists (EURETINA). Ophthalmologica. 2017;237:185–222. - PubMed
    1. Somani S, Koushan K, Shah-Manek B, Mercer D, Kanagenthiran T, Zhao C, et al. Characteristics and treatment patterns of patients with diabetic macular edema non-responsive to anti-vascular endothelial growth factor treatment in Ontario, Canada. Clin Ophthalmol. 2023;17:2013–25. - PMC - PubMed
    1. Busch C, Fraser-Bell S, Iglicki M, Lupidi M, Couturier A, Chaikitmongkol V, et al. Real-world outcomes of non-responding diabetic macular edema treated with continued anti-VEGF therapy versus early switch to dexamethasone implant: 2-year results. Acta Diabetol. 2019;56:1341–50. - PubMed

MeSH terms