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Ali Erginay, Benedicte Marie Dupas, Jean Garrec, Ramin Tadayoni, Pascale G Massin; Real-life experience following the usage of 0.2 µg/day Fluocinolone Acetonide implant in diabetic macular edema patients.. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1749.
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© ARVO (1962-2015); The Authors (2016-present)
The fluocinolone acetonide intravitreal implant (FAc Implant) is indicated for the treatment of vision impairment in Diabetic macular edema (DME) patients. FAc implant was recently approved by the U.S. Food and Drug Administration. Here we summarise the interim analysis from the first DME patients treated in France.
This is a 12 month trial and was designed as a phase 4, single center, open-label trial in DME patients previously treated with focal laser therapy (group 1; n=7) or focal laser plus ≥3 injections of anti-VEGF (group 2; n=10). Patients had been treated with intravitreal steroids (>80% in both treatment groups). Inclusion criteria: central macular thickness (CMT) > 350 µm; best-corrected visual acuity (BCVA) between 20/60 and 20/400; insufficient response to the previous treatment (i.e., change in BCVA < 5 letters)
Prior toFAc implant , median DME duration was 7.6 and 3.6 years in groups 1 and 2. CMT was 573 and 705 µm in these two groups respectively. No correlation was found between DME duration and CMT. More than 80% of these patients were pseudophakic. 6 months afterFAc implant , one patient in group 2 had undergone cataract surgery. At months 1, 3 and 6, CMT decreased by -239, -235 and - 334 µm in group 1 and -173, -167 and -42 µm in group 2. At months 1, 3 and 6, mean BCVA increased by +2.0, +2.2 and +2.7 letters in group 1 and +6.4, +7.8 and +3.2 letters in group 2. Analysis of the gains in BCVA revealed that 3 of the 7 patients in group 1 and 4 of the 10 patients in group 2 gained >5 letters at month 6. At baseline, mean intraocular pressure (IOP) was 15mmHg. One patient in each group was treated with IOP-lowering drops and this occurred between 1 and 3 months. In two cases adjuvant therapy was used. One patient was treated with ranibizumab and the other with triamcinolone.
Interim analysis shows that FAc implant was well tolerated in DME patients and effective. Indeed, following therapy there were rapid and sustained decreases in CMT with concurrent increases in BCVA, particularly at months 1 and 3 in patients previously treated with laser and anti-VEGF (group 2), but not those treated with laser alone (group 1). This may be explained by the longer duration of DME in group 1. This research is ongoing and data will be presented at future events.
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