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Caesar Luo; Early central subfield thickness and long-term visual acuity changes with fluocinolone acetonide (FAc)-associated continuous microdosing in diabetic macular edema. Invest. Ophthalmol. Vis. Sci. 2017;58(8):918.
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© ARVO (1962-2015); The Authors (2016-present)
An injectable implant (FAc 0.2 µg/day; ILUVIEN®) is currently the only approved sustained-release drug delivery system for treatment of diabetic macular edema (DME). The implant provides 36 months’ continuous, submicrogram, intravitreal steroid dosing that is substantially lower than any other intraocular steroid delivery system. With potential benefits beyond the reduction in DME, this study aimed to determine how long-term (36-month) visual acuity (VA) changes compared with early (6-week) changes in DME.
Patients in the FAME clinical trial (n=308) received a mean of 1.3 injections of FAc 0.2 µg/day over 36 months. They were divided into two groups based on central subfield thickness (CST) response at Week 6. Good responders were defined as patients with a maximum CST reduction ≥50 µm (n=201, 65.3%) and minimal responders as those with a CST reduction <50 µm (n=107, 34.7%). Long-term anatomic changes were investigated using CST measurements taken at baseline, Week 6 and at least one time-point after Week 6. VA measurements (determined by best corrected VA [BCVA]) were taken at baseline and one post-baseline visit. VA status was categorized as either improved (≥5-letter gain), stable (±4 letters change) or not improved (≥5-letter loss).
Overall, either a good CST response, or stable/improved vision, or both was seen in 92% of patients. Some patients (18.4%) with CST response still lost vision over 36 months, while approximately half (50.5%) of the patients with minimal CST response experienced vision gain at 36 months (Table 1). A similar proportion of patients lost vision at 36 months in either the good or minimal CST response subgroups. For patients experiencing vision gain at Month 36, irrespective of good or minimal CST response subgroup, a similar proportion received disallowed therapies that consisted primarily of intravitreal anti-VEGF and corticosteroid injections (Table 2).
The results of this study demonstrate that most patients experience a good anatomic (CST) response with stable or improved vision. Even in patients with minimal reduction in CST after 6 weeks, 50% have improved and another 27% have stable vision at Month 36. These results show the long-term benefit of treating DME with continuous microdosing using the FAc 0.2 µg/day implant, with minimal treatments over 36 months.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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