Abstract
PurposeDiabetic macular oedema (DMO) is a leading cause of blindness in working-age adults. Slow-release, nonbioerodible fluocinolone acetonide (FAc) implants have shown efficacy in the treatment of DMO; however, the National Institute for Health and Care Excellence recommends that FAc should be used in patients with chronic DMO considered insufficiently responsive to other available therapies only if the eye to be treated is pseudophakic. The goal of this analysis was to examine treatment outcomes in phakic patients who received 0.2 μg/day FAc implant.MethodsThis analysis of the phase 3 FAME (Fluocinolone Acetonide in Diabetic Macular Edema) data examines the safety and efficacy of FAc implants in patients who underwent cataract extraction before (cataract before implant (CBI) group) or after (cataract after implant (CAI) group) receiving the implant. The data were further examined by DMO duration.ResultsBest corrected visual acuity (BCVA) after 36 months was comparable in the CAI and CBI groups. Both the percentage of patients gaining ≥3 lines of vision and mean change in BCVA letter score were numerically greater in the CAI group. In addition, most patients who underwent cataract surgery experienced a net gain in BCVA from presurgery baseline as well as from original study baseline.ConclusionsThese data support the use of 0.2 μg/day FAc implants in phakic as well as in pseudophakic patients. These findings will serve as a pilot for design of future studies to evaluate the potential protective effect of FAc implants before cataract surgery in patients with DMO and cataract.
Highlights
The baseline characteristics in terms of best corrected visual acuity (BCVA), centre point thickness (CPT), duration and type of diabetes, and glycosylated haemoglobin were similar across all four subgroups (Table 1)
In patients with nonchronic Diabetic macular oedema (DMO), the stabilization did not occur until month 9 (mean CPT of 308 μm at the last visit before cataract surgery; 355 μm at 1 month post surgery and returned to presurgery values by month 9 (312 μm). These findings suggest that macular anatomy was not disturbed following cataract surgery, especially in patients with chronic DMO who had received 0.2 μg/day fluocinolone acetonide (FAc)
The FAc implant was found to be cost effective by National Institute for Health and Care Excellence (NICE) in patients with chronic DMO considered insufficiently responsive to other therapies, provided the eye to be treated was already pseudophakic
Summary
Diabetic macular oedema (DMO) is the most common cause of vision loss in the working-age population, and its chronic nature can necessitate ongoing treatment to maintain vision.[1,2,3] Recent landmark studies have shown that frequent intravitreal injections with inhibitors of vascular endothelial growth factor (VEGF) were more effective than laser photocoagulation for the treatment of centreinvolving DMO.[4,5,6,7,8,9,10,11,12] Despite the visual and anatomical improvements seen in many patients treated with anti-VEGF agents, a sizeable proportion of patients still have a poor response, even with frequently repeated injections.
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