Session Title: Free Paper Session 18: New Drug & Treatment Technology
Session Date/Time: Saturday 09/09/2017 | 14:30-16:00
Paper Time: 15:36
Venue: Room 120
First Author: : J.Coelho PORTUGAL
Co Author(s): : B. Pessoa A. Abreu N. Correia N. Ferreira J. Melo Beirao A. Meireles
To compare the functional, anatomical and safety response after the long-acting sustained release Fluocinolone Acetonide (FAc) implant (0.2 µg/day, ILUVIEN®) between non-vitrectomized and vitrectomized eyes with chronic Diabetic Macular Edema (DME).
One clinical site - Department of Ophthalmology of a tertiary referral centre in Oporto, Portugal - Centro Hospitalar Universitário do Porto
Retrospective, comparative, analysis of 43 eyes with chronic DME. Each eye was treated with a single 0.2 µg/day FAc implant and followed-up for 10,1±7,5 months (mean± standard error). Patients were divided in two groups: 24 eyes who had undergone pars plana vitrectomy prior to 0.2 µg/day FAc implant (group 1), and 19 eyes had not been vitrectomized (group 2). Patients' demographic data, Best-Corrected Visual Acuity (BCVA) measured with an ETDRS chart, duration of DME, number of intravitreal injections, number of topical glaucoma therapy drugs and intraocular pressure (IOP) were recorded. Spectral Domain Optical Coherence Tomography (SD-OCT) – Heidelberg® - was done at each visit. Outcome measures included mean changes in BCVA, Central Foveal Thickness (CFT) and IOP.
Baseline mean BCVA was 40,5±4,1 and 42,1±3,3 letters and mean CFT 543,9±38,2 μm and 523,6±45,7 μm in group 1 and 2 respectively, both P>0,05. There were no baseline differences between groups in age, gender, duration of DME, number of previous intravitreal injections and IOP – P>0,05. There were no differences between groups in the mean follow-up time (group 1: 9,37±7,0; group 2: 10,4±7,6; respectively - P>0,05). The ratio of pseudophakic:phakic eyes was 23:1 in group 1 and 12:7 in group 2. Phakic eyes had documented mild cataract development during follow-up. Mean BCVA improved in both groups compared to baseline until the ninth month of follow-up (9 patients achieved at least 9 months of follow-up in both groups). At last visit, group 1 have an increase from baseline of 13,7 EDTRS letters (–6 to +48; P<0,001) vs 11,5 EDTRS letters (-20 to +53; P=0,027) in group 2. At last visit, mean CFT decrease in both groups versus baseline (group 1: -227,8±199,7μm and group 2: -197,8±183,9μm, both P<0.001). At last observation point no differences were seen between the groups in BCVA, CFT and CFT, BCVA and IOP variation from baseline – P>0,05.
In this analysis, the clinical findings were similar between non-vitrectomized and vitrectomized eyes. 0.2 µg/day FAc implant led to statistically significant results with long-term functional improvements in visual acuity and macular thickness with little change in IOP in both groups. This analysis supports the early use of 0.2 µg/day FAc implant in DME patients despite their vitreous status.