Abstract
PurposeTo investigate the changes in vitreous inflammatory and angiogenic cytokine levels, primarily interleukin-(IL)-6, following intravitreal injection of the 0.19 mg fluocinolone acetonide (FAc, ILUVIEN®) implant in patients with diabetic macular edema.MethodsA single-center phase IV study involving 12 patients’ eyes with diabetic macular edema. Vitreous fluid samples were obtained prior to intravitreal injection of the fluocinolone acetonide implant and then again over a 6-month period. Vitreous samples were examined using a cytometric bead array to measure IL-6, IL-8, IP-10, MCP-1, VEGF, and CD54. PIGF and PEDF were measured using an enzyme-linked immunosorbent assay. Changes in the cytokine and chemokine expression patterns were analyzed. Clinical parameters such as BCVA and center point thickness (CPT) were also examined.ResultsThere were mean reductions in all parameters between baseline and month 6. Significant changes (p < 0.05 versus baseline) were observed in the expression of IL-6, IP-10, MCP-1, and CD54 following the administration of fluocinolone acetonide implant. VEGF and PIGF increased at month 1 before declining at month 6, though this trend was not significant. CPT decreased rapidly between screening and the first follow-up visit, and this decrease was sustained. BCVA remained relatively stable throughout.ConclusionThis study demonstrated changes in vitreous inflammatory and angiogenic cytokine levels following intravitreal injection of the FAc implant in patients with diabetic macular edema. Data show that the fluocinolone acetonide implant led to rapid and sustained reductions of some inflammatory cytokines with improvement of the overall clinical picture.
Highlights
Diabetic macular edema (DME) is a complication of diabetic retinopathy (DR) and is the leading cause of vision loss in diabetics
Corticosteroids are multi-factorial in nature and target vascular endothelial growth factor (VEGF) and several inflammatory cytokines relating to the development of DR and DME [6]
Previous investigations have shown that the pharmacokinetics of the FAc implant are unique compared to other commonly injected intravitreal corticosteroids as it delivers a lower daily dose of corticosteroid over a 3-year period [2], meaning that other preparations have a limited durability of release compared to the FAc implant [9]
Summary
Diabetic macular edema (DME) is a complication of diabetic retinopathy (DR) and is the leading cause of vision loss in diabetics. Current treatment options for DME include intravitreal anti-vascular endothelial growth factor (VEGF) agents (ranibizumab, aflibercept and off-label injections of bevacizumab) and intravitreal corticosteroids (0.2 μg/ day fluocinolone acetonide [FAc] implant, dexamethasone implant, and off-label injections of triamcinolone acetonide). The FAc ILUVIEN® implant was designed to provide continuous treatment with fluocinolone acetonide for up to 3 years [2] and is delivered via an intravitreal injection for the treatment of DME that persists or recurs despite therapy. The outcomes from both clinical trials [3] and real-world practices [4, 5] have consistently shown that therapy with the FAc implant leads to rapid and sustained improvements of visual acuity and center point thickness (CPT). Previous investigations have shown that the pharmacokinetics of the FAc implant are unique compared to other commonly injected intravitreal corticosteroids as it delivers a lower daily dose of corticosteroid over a 3-year period [2], meaning that other preparations have a limited durability of release compared to the FAc implant [9]
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