# Efficacy and safety of fluocinolone acetonide intravitreal implant (0.2 µg/day) in patients with post-surgical inflammation associated with macular edema: a case series study

**Authors:** Maria Madeira, Ana Cabugueira, Helena Urbano, Miguel Cordeiro, Marta Guedes

PMC · DOI: 10.1186/s12348-025-00503-8 · Journal of Ophthalmic Inflammation and Infection · 2025-08-16

## TL;DR

This study shows that a fluocinolone implant improves vision and reduces swelling in patients with persistent eye inflammation after surgery.

## Contribution

The study demonstrates the efficacy and safety of a fluocinolone implant for refractory post-surgical macular edema.

## Key findings

- Patients showed significant improvement in visual acuity over 36 months.
- Central retinal thickness decreased significantly during the study period.
- Intraocular pressure remained stable with no serious safety concerns.

## Abstract

Postoperative cystoid macular edema (PCME) is a primary cause of reduced vision following both cataract and/or vitreoretinal surgery, which may spontaneously resolve. This study aimed to evaluate the effectiveness and safety of the fluocinolone acetonide intravitreal (FAc) implant (0.2 µg/day) in patients with refractory PCME.

Retrospective, non-interventional, and single center study conducted on patients with PCME treated with 0.2 µg/day FAc implant. All the patients received previous treatment with topical corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), triancinolone injection and dexamethasone implant. The primary end-points were the mean change in best-corrected-visual-acuity (BCVA) and the proportion of patients gaining ≥ 15 letters from baseline to the last follow-up visit. The secondary endpoints included the mean CRT reduction and the mean intraocular pressure (IOP) during the 36 months study period.

Eight eyes from 8 patients were included in the study. Median (95% Confidence-interval) BCVA was significantly improved from 60.0 (50.05–69.95) letters at baseline to 80.15 (77.25-85.00) letters at month-36, p = 0.043. At the last follow-up visit, 5 (62.5%) eyes gained ≥ 15 letters, without any eye experiencing a loss of BCVA compared to baseline. There was significant CRT reduction from baseline (median: 497.5 μm; 95%CI: 380.0–596.0 μm) to month-36 (Median: 252.0 μm; 95%CI: 242.0–268.0 μm); p = 0.012. Regarding safety, IOP remained stable from baseline (median: 14.5mmHg; 95%Confidence-interval: 12.0–23.0 mmHg) to the last follow-up visit (median: 13.5mmHg; 95% Confidence-interval: 9.0–19.0 mm Hg); p = 0.123.

The FAc implant significantly improved both visual and anatomic outcomes, and was effective in preventing recurrences, while maintaining a reasonable safety profile, in PCME refractory to intravitreal triancinolone and dexamethasone.

## Linked entities

- **Chemicals:** fluocinolone acetonide (PubChem CID 6215), dexamethasone (PubChem CID 5743)
- **Diseases:** cataract (MONDO:0005129)

## Full-text entities

- **Genes:** VEGFA (vascular endothelial growth factor A) [NCBI Gene 7422] {aka L-VEGF, MVCD1, VEGF, VPF}, FANCC (FA complementation group C) [NCBI Gene 2176] {aka FA3, FAC, FACC}
- **Diseases:** retinal vein occlusion (MESH:D012170), diabetes (MESH:D003920), toxicity (MESH:D064420), cataract (MESH:D002386), loss of BCVA (MESH:D014786), ocular hypotensive (MESH:D015814), SRF (MESH:D006949), trauma (MESH:D014947), vitreous loss (MESH:D014823), uveitis (MESH:D014605), rhegmatogenous retinal detachment (MESH:C563710), epiretinal membrane (MESH:D019773), intraretinal cysts (MESH:D003560), HRF (MESH:C565785), MFM (MESH:C563718), inflammation (MESH:D007249), PCME (MESH:D008269), AC (MESH:C535679), glaucoma (MESH:D005901), Diabetic Retinopathy (MESH:D003930), hypertension (MESH:D006973)
- **Chemicals:** Dexamethasone (MESH:D003907), steroid (MESH:D013256), inflammatory drugs (-), triamcinolone (MESH:D014221), fluocinolone acetonide (MESH:D005446), triamcinolone acetonide (MESH:D014222), DEX (MESH:D003915)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Full text

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## Figures

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## References

2 references — full list in the complete paper: https://tomesphere.com/paper/PMC12356776/full.md

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Source: https://tomesphere.com/paper/PMC12356776