Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
Continuous efficacy and safety of fluocinolone acetonide implant: long-term insights in diabetic macular edema patients from a portuguese hospital.
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Pires Daniela Figueiredo, Ferreira André, Coelho João, Caiado Filipa, Borges Tânia, Correia Nuno, Menéres Maria João, Pessoa Bernardete
Аннотация
PURPOSE: To assess the efficacy and safety of the 0.19 mg intravitreal fluocinolone acetonide (FAc) implant over a 36-month period in patients with refractory diabetic macular edema (DME).
METHODS: Retrospective, single-center study including patients with refractory DME treated with the FAc implant, with outcomes assessed over 36 months. The primary endpoint was the proportion of eyes with CRT ≤ 280 μm at month 36.
RESULTS: Ninety-one eyes from 62 patients were included, with a mean baseline BCVA of 44.7 ± 18.1 ETDRS letters, CRT of 508.6 ± 176.2 μm, and DME duration of 3.6 ± 1.9 years. Eyes had received a median of 6 anti-VEGF injections (IQR, 3-13) and 2 corticosteroid injections (IQR, 1-3), and 23 (25.3%) were phakic. At month 36, 44 of 87 evaluable eyes (50.6%) had a CRT ≤ 280 μm (p < 0.0001). Mean BCVA increased by 9.4 ETDRS letters from baseline to month 36 (p < 0.0001), while mean macular volume decreased by 1.76 mm³ (p < 0.0001). Adjunctive intravitreal treatment was required in 52 eyes (57.1%), and 11 eyes (12.1%) received a second FAc implant. IOP-lowering treatment was initiated or intensified in 45 eyes (49.5%), 33 eyes (36.3%) met event-based criteria for ocular hypertension, and 8 eyes (8.8%) required glaucoma surgery. All phakic eyes at baseline (n = 23) subsequently underwent cataract surgery.
CONCLUSION: The 0.19 mg FAc implant was associated with sustained anatomical and functional improvements over 36 months as part of the management of refractory DME. Long-term IOP monitoring remains essential.
METHODS: Retrospective, single-center study including patients with refractory DME treated with the FAc implant, with outcomes assessed over 36 months. The primary endpoint was the proportion of eyes with CRT ≤ 280 μm at month 36.
RESULTS: Ninety-one eyes from 62 patients were included, with a mean baseline BCVA of 44.7 ± 18.1 ETDRS letters, CRT of 508.6 ± 176.2 μm, and DME duration of 3.6 ± 1.9 years. Eyes had received a median of 6 anti-VEGF injections (IQR, 3-13) and 2 corticosteroid injections (IQR, 1-3), and 23 (25.3%) were phakic. At month 36, 44 of 87 evaluable eyes (50.6%) had a CRT ≤ 280 μm (p < 0.0001). Mean BCVA increased by 9.4 ETDRS letters from baseline to month 36 (p < 0.0001), while mean macular volume decreased by 1.76 mm³ (p < 0.0001). Adjunctive intravitreal treatment was required in 52 eyes (57.1%), and 11 eyes (12.1%) received a second FAc implant. IOP-lowering treatment was initiated or intensified in 45 eyes (49.5%), 33 eyes (36.3%) met event-based criteria for ocular hypertension, and 8 eyes (8.8%) required glaucoma surgery. All phakic eyes at baseline (n = 23) subsequently underwent cataract surgery.
CONCLUSION: The 0.19 mg FAc implant was associated with sustained anatomical and functional improvements over 36 months as part of the management of refractory DME. Long-term IOP monitoring remains essential.