A retrospective evaluation of the efficacy and safety of fluocinolone acetonide 0.2 μg implant in patients with chronic diabetic macular edema with insufficient response to other therapies

Abstract

Purpose : Anti-vascular endothelial growth factor (VEGF) therapies are robust and effective as first line treatment in diabetic macular edema (DME). However, up to 50% of initial VEGF treated patients may have an insufficient response (ISR) and it is thought that inflammatory cytokine pathways, other than VEGF may be responsible for edema recurrence or not complete resolution of fluid despite multiple intravitreal injections. Hence the use of a 2nd line, steroid may be of benefit in these ISR and chronic DME patients. The purpose of this study was to evaluate safety and efficacy of fluocinolone acetonide (FAc) 0.2 μg implant in patients with chronic DME with insufficient response (ISR) to other therapies.

Methods : This non-interventional, retrospective, case series evaluated 18 eyes of 13 patients with chronic DME ISR to other therapies who received one intravitreal FAc implant (0.2 μg). Main outcomes measured at baseline, 2-4 weeks, 3 months and 6 months after injection were visual acuity (VA) (ETDRS) and central retinal thickness (CRT) by optical coherence tomography. Secondary outcomes, measured at same time, were macular volume (MV) and intraocular pressure (IOP). All patients included in this study, which adhered to the tenets of the Declaration of Helsinki, gave their informed consent to treatment.

Results : Before injection (mean ± SE) was: VA (letters): 36.7L ± 4.98; CRT: 584.5μm ± 46.24; MV: 11.03 mm3 ± 0.47 and IOP:15.9 mmHg ± 0.59. Six months after injection, VA was 60.0 L ± 7.63, CRT was 406.5 μm ± 102.80, MV was 8.65mm³ ± 0.57 and IOP was 15.3 mmHg ± 0.71. Mean change from baseline to month 6 was: 23.3L ± 3.47 for VA (P=0.001); -228.5 μm ± 105.63 for CRT (P = 0.083); -3.02 mm³ ± 0.88 for MV (P = 0.042); and -1.2 mmHg ± 1.17 for IOP. The decrease in IOP seen in this study might be explained by 33% (n=6) of patients being on prior IOP medication, that received an additional IOP lowering medication during the study.

Conclusions : Over the 6 months follow up period of this study, patients with Chronic DME with ISR to other available treatments responded with a significant and sustained improvement in VA and decrease in CRT after one intravitreal implant of FAc. Early treatment with FAc may be considered in patients with DME refractory to “conventional” treatments.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.