Sustained Intraocular Delivery of Fluocinolone Acetonide Slows Progression of Diabetic Retinopathy

Abstract

Purpose : The FAME trials demonstrated that 0.2 μg/d fluocinolone acetonide (FAc) intravitreal implants significantly improved visual acuity and reduced retinal thickness compared with sham control over 36 months in patients with diabetic macular edema (DME). However, it is unknown whether 0.2 μg/d FAc implants slow progression of diabetic retinopathy (DR).
The goal of the present study was to evaluate proliferative DR (PDR) progression, based on time to first PDR event and change in diabetic retinopathy severity scale (DRSS) steps according to baseline Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS level and DME duration, respectively, in patients with DME who received sham control or 0.2 μg/d FAc during the 36-month FAME trials.

Methods : A masked reading center (University of Wisconsin-Madison) determined baseline ETDRS DRSS using standard 7-field stereo fundus photography and fluorescein angiography. PDR progression was assessed using 3 measures: progression from nonproliferative DR to PDR based on graded fundus photographs, panretinal photocoagulation (PRP), or pars plana vitrectomy (PPV) for PDR. Retinopathy changes were determined by ETDRS step differences from baseline to month 36.

Results : In the integrated FAME analysis, compared with sham control–treated patients, time to first PDR event was significantly delayed in patients treated with 0.2 μg/day FAc (P < .001). In patients with DRSS levels 47-53 or 60-75, treatment with 0.2 μg/day FAc was associated with a significant delay in time to first PDR event compared with sham control (P = .002 and P = .011, respectively). Among patients with chronic DME, compared with sham control–treated patients, a significantly greater percentage of patients who received 0.2 μg/day FAc experienced a ≥ 2-step (8.3% vs 16.7%; P < .05) and ≥ 3-step (0% vs 3.5%; P < .05) improvement in DRSS score. Conversely, compared with patients who received sham control, significantly fewer patients with chronic DME who were treated with 0.2 μg/day FAc experienced ≥ 3-step worsening (3.7% vs 0.5%; P < .05) in DRSS score, and a similar trend was noted regarding ≥ 2-step DRSS score worsening (7.3% vs 6.1%); however, this difference was not statistically significant.

Conclusions : In patients with DR and macular edema, sustained intraocular delivery of FAc slows progression of DR.

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