Efficacy and safety of sustained-delivery fluocinolone acetonide intravitreal implant in patients with chronic diabetic macular edema insufficiently responsive to available therapies: a real-life study
Authors Massin P, Erginay A, Dupas B, Couturier A, Tadayoni R
Received 30 January 2016
Accepted for publication 31 March 2016
Published 8 July 2016 Volume 2016:10 Pages 1257—1264
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Gokcen Gökçe
Peer reviewer comments 3
Editor who approved publication: Dr Scott Fraser
Pascale Massin, Ali Erginay, Bénédicte Dupas, Aude Couturier, Ramin Tadayoni
Ophthalmology Department, Lariboisière Hospital, Paris, France
Purpose: To evaluate the efficacy and safety of sustained-delivery fluocinolone acetonide (FAc) intravitreal implant for diabetic macular edema (DME).
Patients and methods: Prospective study in patients with DME insufficiently responsive to laser and anti-vascular endothelial growth factor (anti-VEGF). Patients with history of rise of intraocular pressure after intravitreal corticosteroids were excluded.
Results: The macular edema rapidly decreased both in group 1 (prior laser only; n=7 eyes) and group 2 (prior laser and ≥3 monthly anti-VEGF therapy; n=10 eyes) and central subfield thickness was reduced by -299 µm (P=0.008) and -251 µm (P=0.016) at 12 months, respectively. Mean area under the curve from baseline to last value for pseudophakic eyes was +4.2 letters in group 1 and +9.5 letters in group 2. Overall, the FAc implant was well tolerated.
Conclusion: This prospective study confirms the efficacy of the FAc implant in DME patients insufficiently responsive to laser and anti-VEGF. Moreover, with a careful patient selection, our safety results would support an earlier use of FAc in the DME treatment pathway.
Keywords: diabetic macular edema, intravitreal corticosteroid, corticosteroid intravitreal implant, fluocinolone acetonide
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