Author: Ana Rita Viana (Portugal)
Co-authors: Carla Teixeira, Rui Carvalho, Renato Barbosa, Rita Basto, Sara Pereira, Paula Tenedório
Diabetic Macular Edema (DME) is the main cause of vision impairment among diabetic patients. The fluocinolone acetonide (FAc, 0.19 mg, ILUVIEN®) intravitreal implant is a therapy option for persistent and recurrent DME, releasing a sustained microdose of FAc for up to 3 years. The aim of the present study is to evaluate the visual and anatomical outcomes and also to draw a long-term safety profile of intravitreal FAc implant for the treatment of DME.
This study evaluates the functional and anatomical long-term outcomes following FAc intravitreal implant in patients with DME, carried out at the ophthalmology department of Hospital Pedro Hispano, Portugal.
Retrospective study of 109 eyes from 76 patients with persistent DME treated with FAc intravitreal implant 0.19 mg. Demographic data of the patients, best corrected visual acuity (BCVA), central retinal thickness (CRT), duration of DME, number of previous intravitreal anti-VEGF or short-acting steroid injections and intraocular pressure (IOP) prior to FAc implant placement were recorded at baseline. BCVA, CRT and IOP were evaluated at month 1, 3 and then quarterly, and a comparison of these parameters was established over 3 years. The percentage of patients that improved or stabilized BCVA was ascertained. Adjuvant intravitreal therapies and IOP-lowering drugs needed throughout study were also recorded. Percentage of patients that performed FAc implant reinjection 36 months after the first one was recorded.
The average follow-up period was 26.5 ± 10.8 months. At baseline, the mean age was 68.5 ± 8.8 years. Thirty-eight patients were men. At baseline, 30.5% of the eyes were phakic. The mean duration of DME was 4.6 ± 1.9 years. All eyes received intravitreal injections of anti-VEGF and/or short-acting steroids prior to the FAc implant, with an average number of 6.9 ± 4.8 anti-VEGF injections and 2.1 ± 1.5 short-acting steroids injections. The mean baseline BCVA was 49.3 ± 12.3 early treatment diabetic retinopathy study (ETDRS) letters, with an average increase of +9.2 ETDRS letters observed in the last observation, which was statistically significant (p<0.001). Eighty-seven percent of the patients maintained or improved BCVA compared to baseline. The mean CRT significantly decreased by 156.4 μm from the baseline 502.0 ± 176.1 μm (p<0.001). Throughout the study, 34.1% of the eyes required adjuvant intravitreal injections. Thirty-four percent of the eyes registered an IOP increase related to FAc implant requiring IOP-lowering medication and 14% of the eyes underwent selected laser trabeculoplasty (SLT). Eighty-one percent of the baseline phakic eyes underwent phacoemulsification surgery during the follow-up period. After 36 months post-FAc implant, 35.6% of the eyes underwent FAc reinjection.
This study demonstrates that FAc intravitreal implant is a valid treatment option in chronic and recurrent DME, with positive anatomical and functional responses maintained for a long-term period. The majority of patients who reached 36 months of follow-up after FAc implant did not need retreatment after this period. IOP monitoring remains essential in these patients, as well as cataract progression vigilance. Safety parameters and lateral effects were known, well managed and controlled during the follow-up period.
No financial relations.