Abstract
AimsTo compare safety outcomes and visual function data acquired in the real-world setting with FAME study results in eyes treated with 0.2 μg/day fluocinolone acetonide (FAc).MethodsFourteen UK clinical sites contributed to pseudoanonymised data collected using the same electronic medical record system. Data pertaining to eyes treated with FAc implant for diabetic macular oedema (DMO) was extracted. Intraocular pressure (IOP)-related adverse events were defined as use of IOP-lowering medication, any rise in IOP>30 mm Hg, or glaucoma surgery. Other measured outcomes included visual acuity, central subfield thickness (CSFT) changes and use of concomitant medications.ResultsIn total, 345 eyes had a mean follow-up of 428 days. Overall, 13.9% of patients required IOP-lowering drops (included initiation, addition and switching of current drops), 7.2% had IOP elevation >30 mm Hg and 0.3% required glaucoma surgery. In patients with prior steroid exposure and no prior IOP-related event, there were no new IOP-related events. In patients without prior steroid use and without prior IOP-related events, 10.3% of eyes required IOP-lowering medication and 4.3% exhibited IOP >30 mm Hg at some point during follow-up. At 24 months, mean best-recorded visual acuity increased from 51.9 to 57.2 letters and 20.8% achieved ≥15-letter improvement. Mean CSFT reduced from 451.2 to 355.5 μm.ConclusionsWhile overall IOP-related emergent events were observed in similar frequency to FAME, no adverse events were seen in the subgroup with prior steroid exposure and no prior IOP events. Efficacy findings confirm that the FAc implant is a useful treatment option for chronic DMO.
Highlights
Diabetic macular oedema (DMO) is a serious visual complication of diabetic retinopathy, one of the leading causes of vision loss among working-age adults.[1]
What was known before K 0.2 μg/day fluocinolone acetonide (FAc) implant is indicated for the treatment of vision impairment associated with chronic diabetic macular oedema, considered insufficiently responsive to available therapies
K At the time of the FAME study, the standard of care for DMO was predominantly laser, but a course of intravitreal anti-vascular endothelial growth factor (VEGF) injections is widely used before considering intravitreal steroid treatment
Summary
Diabetic macular oedema (DMO) is a serious visual complication of diabetic retinopathy, one of the leading causes of vision loss among working-age adults.[1]. In a post hoc analysis of the Diabetic Retinopathy Clinical Research Network Protocol I study, 40% of eyes had an insufficient response (o5-letter improvement in best-corrected visual acuity (BCVA) from baseline) to anti-VEGF therapy at 3 months.[8] In the Studies of Ranibizumab Injection in Subjects with Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus (RIDE and RISE), 13% of patients experienced no change or a decrease in visual acuity score at Month 24 following 0.5 mg ranibizumab therapy.[5] AntiVEGF therapies require regular follow-up and usually multiple injections, resulting in a substantial treatment burden for patients and hospital eye services.[9]
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