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Charles Clifton Wykoff; Continuous submicrogram fluocinolone acetonide (FAc) therapy for the treatment of diabetic retinopathy. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2949.
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© ARVO (1962-2015); The Authors (2016-present)
FAc intravitreal implant (ILUVIEN®) is the only approved therapy for diabetic macular edema that delivers continuous local therapy for 36 months and has been shown to slow the progression of proliferative diabetic retinopathy (PDR) in the FAME trial involving 956 patients. The current post-hoc analysis of the FAME dataset compared change in mean DR severity scale (DRSS) score, and time to ≥2-step improvement and ≥2-step worsening between FAc- and sham control-treated patients, with an emphasis on the most at-risk, non-proliferative DR (NPDR) subgroups.
Patients from the FAME trial who received 0.2 µg/day FAc were followed over 36 months and assessed for change in progression of PDR, mean DRSS score and time to ≥2-step improvement or worsening in DR grade compared with sham control-treated patients. The influence of baseline DRSS level on progression was also considered.
The proportion of patients with PDR progression was significantly reduced at Month 36 in FAc- compared with sham control-treated patients in the overall population (18% vs 31%, respectively; P<0.001) and the difference was even greater in patients with baseline NPDR levels 47–53 (18% vs 35%, respectively; P<0.002). Change in overall mean DRSS score between FAc- and sham control-treated patients demonstrated a statistically significant difference at almost every time point, including Month 36. A greater proportion of FAc-treated patients achieved ≥2-step improvement in DRSS over time compared with sham-control patients (P=0.03) and this effect was more apparent in the 47–53 subgroup (P=0.008). FAc treatment reduced the proportion of patients developing ≥2-step worsening in DRSS over time compared with sham-control patients (P=0.028) and again, this reduction was more apparent in the 47–53 subgroup (P=0.001; Table).
These results show that 0.2 µg/day FAc is an efficacious treatment for delaying PDR progression, and is especially effective in the most at-risk NPDR population; those with moderately-severe and severe NPDR. Treatment with 0.2 µg/day FAc maintains therapeutic benefit for a minimum of 36 months, as shown by significantly reduced PDR progression, significant difference in overall mean DRSS score, increased ≥2-step improvement and reduced ≥2-step worsening in DRSS over time compared with sham-control patients over 36 months.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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