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Richard K Parrish, FAME; Changes in the cup-to-disc ratio in patients with diabetic macular edema (DME) treated with fluocinolone acetonide (FAc) implants. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1784.
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Elevated IOP is a common adverse event associated with ocular corticosteroids. Because of concerns regarding glaucomatous change associated with elevated IOP, patients in the Fluocinolone Acetonide for Diabetic Macular Edema (FAME) study were assessed for changes in the optic nerve head.
Patients in the randomized phase 3 FAME trials received sham injection (control; n = 185), or active treatment with 0.2 μg/d FAc (n = 376) or 0.5 μg/d FAc (n = 395) implants. The University of Wisconsin Fundus Photograph Reading Center performed the grading of the optic nerve head in the study eye using color digital and Field One film images. Two independent graders trained in optic nerve head evaluations performed measurements of the vertical cup and disc to determine the effect of FAc. Images were analyzed at baseline and month 36, or last observation in the absence of month 36 assessment.
Baseline and post-baseline assessments were available in 169 control patients, 354 patients treated with 0.2 μg/d FAc, and 368 patients treated with 0.5 μg/d FAc. The mean change in vertical cup-to-disc ratio was 0.005 for control, 0.016 for 0.2 μg/d FAc, and 0.014 for 0.5 μg/d FAc. The number of patients with a worsening (increase from baseline > 0.1) in the vertical cup-to-disc ratio was 2 (1.2%) for control, 12 (3.5%) for 0.2 μg/d FAc and 17 (4.7%) for 0.5 μg/d FAc. A clinically meaningful change (increase from baseline of > 0.2) occurred in 0 control patients, 4 patients (1.2%) receiving 0.2 μg/d FAc, and 3 patients (0.8%) receiving 0.5 μg/d FAc. Confounding factors, such as heavy use of panretinal photocoagulation or loss of glycemic control, were noted in some of these patients.
A clinically meaningful worsening in the cup-to-disc ratio was noted in a small proportion of patients treated with 0.2 μg/d FAc implants, which may have been confounded by factors unrelated to treatment. Overall the risk of glaucomatous change is low for these patients, many of whom experienced significant visual benefit in the study.
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