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Raymond Iezzi, Barry Kapik, Ken E Green; Progression of diabetic retinopathy in patients treated with 0.2 μg/day fluocinolone acetonide (FAc) implants for diabetic macular edema (DME): a fellow eye-controlled analysis. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2950.
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Previous studies have shown that the risk of diabetic retinopathy (DR) progression increases significantly with severity of baseline non-proliferative DR (NPDR). In the FAME trial, 0.2 μg/day FAc implants significantly improved vision in patients with DME compared with sham control-treated patients. The current analysis compares the DR progression rates in 0.2 μg/day FAc-treated versus fellow eyes.
FAc-treated patients from the FAME trials who had baseline and follow-up fundus photographs, graded for DR severity score (DRSS) by a masked reading center, were included in the Kaplan-Meier (KM) analysis (N=322). DR progression based on ≥2-step ETDRS DRSS improvement or worsening in severity level was compared between FAc treated and fellow eyes. For each patient in this analysis, the FAc treated eye was compared to the fellow eye control. The percentage chances of DRSS improvement or worsening were then computed, based on the KM probabilities for each group through 36 months of follow-up.
After 3 years, the overall population (N=322) of FAc-treated eyes had a 32.7% chance of improving by ≥2 DRSS steps versus 23.7% in fellow eye controls (P=0.004). Further, the chance of worsening by 2 DRSS steps was 13.7% among FAc treated eyes versus 23.2% in fellow eye controls (P=0.140). When the subgroup of patients with matched baseline DRSS for FAc-treated and fellow eyes were compared, the same trends in treatment effects were observed as seen in the overall population, although these were not statistically significant (p≥0.114). In patients with asymmetric DR that did not have matched DRSS at baseline, a distinct trend for better outcome in the eye with lower DR score emerged, irrespective of treatment.
The continuous nature of localized treatment associated with the FAc implant allows for this unique comparison of DR progression between FAc-treated and fellow eyes. We observed that treatment with FAc was associated with a greater probability of ≥2 DRSS step improvement as compared to fellow eye controls. We also observed a treatment-independent progression observed in patients with asymmetric retinopathy. This may indicate the importance of treating DR early in order to modify or reverse the effects of DR.
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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