Fluocinolone Acetonide Implants Protect Against Diabetic Macular Edema

Investigators from the University Hospital of Erlangen-Nuremberg recently published a study establishing intravitreal fluocinolone acetonide (FA)'s ability to reduce and stabilize central retinal thickness (CRT) in patients with chronic diabetic macular edema (DME) and non-infectious uveitis affecting the posterior segment (NIU-PS) without losing visual acuity.1

In 2021, roughly 537 million people globally had diabetes; experts predict global cases will rise to 783 million by 2045. Longer diabetes duration, poor metabolic control, high blood cholesterol, hypertension, and nephropathy, along with smoking and genetic disposition, are all risk factors for the development of diabetic retinopathy. This condition’s pathogenesis is directly tied to DME, which is projected to reach 366 million cases worldwide by 2030.2

Retinal thickness fluctuations present a significant challenge in the management and treatment of DME. Mechanical stress on the retina can lead to irreversible damage, contributing to functional vision loss. Steroidal implants, such as FA, are widely used in Europe to treat chronic DME and to prevent relapse in eyes with NIU-PS. FA functions by constantly releasing microdoses of 0.2 µg/day for up to 36 months.1

“Our retrospective real-world study including patients with DME and NIU-PS, we observed sustained structural improvement in combination with improvement and stabilization of VA that could be achieved up to three years with single intravitreal injection of FA in our cohorts,” wrote Bettina Hohberger, MD, department of ophthalmology, Friedrich-Alexander-University Erlangen-Nürnberg, and colleagues. “Fluctuations in CRT were reduced with a tolerable safety profile.”1

The team collected data from the last examination before and at each examination after FA injection. A total of 36 patients were included, who were then divided evenly into 2 cohorts: those with DME and those with NIU-PS.

The DME cohort included 21 eyes of 18 patients, with a mean follow up of 792.5 +/- 462.5 days. The mean age of patients treated with the FA implant was 66.6 +/- 5.9 years, with the majority being pseudophakic (78.3%). None of the eyes had an intraocular pressure (IOP) >33 mmHg at baseline, and all except one (n = 20) received prior anti-VEGF, steroid, or laser treatment, with 66.7% (n = 14) receiving intravitreal steroids.1

The NIU-PS cohort included 25 eyes from 18 patients, with a mean follow-up of 977.2 +/- 686.5 days. Mean age was 55 +/- 11.4 years with 64% pseudophakic and 36% phakic at baseline. Most eyes were diagnosed with non-infectious posterior uveitis (84%). A total of 88% of eyes had prior dexamethasone implants, and 59.1% were switched to FA after up to two dexamethasone implants.1

After an initial decrease in CRT during year 1, maximum CRT amplitude significantly decreased in the following years in both cohorts. Patients with DME saw a CRT amplitude reduction from 271.4 to 91.57 µm in the first year (P = .0056) and 106 µm in the second year (P = .0109). Patients with NIU-PS saw a CRT amplitude reduction from 185.2 to 87.7 µm in the first year (P = .0131) and 97.3 µm in the second year (P = .0375).1

Best-corrected visual acuity (BCVA) non-significantly increased in the NIU-PS cohort and remained stable in the DME cohort. Adverse events only occurred in a few cases, and investigators noted the percentage of eyes that needed IOP-lowering medication (42.9% in eyes with DME, 32% in eyes with NIU-PS) were comparable to or lower than previous trials. Only 2 eyes with NIU-PS developed glaucoma after FA treatment, and the rate of cataract formation and surgery was reported in 40% (5/21) of eyes with DME and 36% (9/25) eyes with NIU-PS.1

Investigators noted these results indicate a good safety profile in a real-world setting. Secondary infections, such as herpes, often occur during immunosuppressive treatment of non-infectious uveitis; however, this was not exhibited during this trial. Additionally, after FA implantation, treatment frequency could be reduced, given low supplementary therapy rates and a decrease in CRT fluctuations.1

“The exploratory nature of our findings indicates that the stabilization of CRT fluctuations—combined with a reduced treatment burden—could offer potential benefits of an earlier switch to FA, possibly improving patient compliance and reducing the risk of future retinal damage, ultimately leading to better VA outcomes,” Hohberger and colleagues wrote.1

References

1. Hohberger B, Royer M, Flamann CS, Bergua A. Stabilizing Macular Edema Fluctuations: Outcomes of Intravitreal Fluocinolone Acetonide for Diabetic Macular Edema and Non-Infectious Uveitis. J Clin Med. 2025;14(8):2849. Published 2025 Apr 21. doi:10.3390/jcm14082849

2. Dong N, Xu B, Wang B, Chu L. Study of 27 aqueous humor cytokines in patients with type 2 diabetes with or without retinopathy. Mol Vis. 2013;19:1734-1746. Published 2013 Aug 4.