Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants

• Published in: Eye (London) 2015-09, Vol.29 (9), p.1173-1180
• Main Authors: Yang, Y, Bailey, C, Holz, F G, Eter, N, Weber, M, Baker, C, Kiss, S, Menchini, U, Ruiz Moreno, J M, Dugel, P, Lotery, A
• Format: Article
• Language: English
• Subjects: 692/699/3161/3168; 692/699/3161/3175; Adult; Aged; Clinical Study; Delayed-Action Preparations - administration & dosage; Diabetic Retinopathy - drug therapy; Drug Implants; Female; Fluocinolone Acetonide - administration & dosage; Follow-Up Studies; Glucocorticoids - administration & dosage; Humans; Laboratory Medicine; Macular Edema - drug therapy; Male; Medicine; Medicine & Public Health; Middle Aged; Ophthalmology; Pharmaceutical Sciences/Technology; Pseudophakia - drug therapy; Surgery; Surgical Oncology; Visual Acuity
• ISSN: 0950-222X; 1476-5454
• DOI: 10.1038/eye.2015.98

Purpose Diabetic 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  μ g/day FAc implant. Methods This 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. Results Best 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. Conclusions These data support the use of 0.2  μ g/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.