Optical Coherence Tomography Biomarkers - Vitreous Status Influence in Outcomes for Diabetic Macular Edema Therapy with 0.19 mg Fluocinolone Acetonide Implant

Abstract

Purpose : To quantitatively assess functional and structural features in non-vitrectomized and vitrectomized DME patients after being treated with a FAc implant and to evaluate their influence in DME treatment response.

Methods : A retrospective review was conducted involving patients with DME who received a single intravitreal injection of the FAc implant at the Centro Hospitalar Universitário do Porto, Portugal. The study was designed to analyze the presence of quantitative structural OCT biomarkers at baseline and 12 months after FAc therapy according to vitreous status: vitrectomized eyes (group 1) and non-vitrectomized eyes (group 2). The secondary objectives were to analyze differences in treatment response and the need for additional therapy as well as to correlate those biomarkers with response to therapy. A significant functional improvement was considered a gain of at least 5 ETDRS letters. DME resolution was defined by CFT ≤ 300 µm. The type of response was classified as (1) good responder when at 12-months post-FAc implant there was DME resolution with a significant functional improvement without additional treatments; (2) non-responder, when there was a CFT > 400 µm or ≤ 10% of CFT reduction and BCVA decrease (or BCVA gain < 5 letters); (3) moderate responder - between good and non-responder criteria; (4) non-good responders include non-responders and moderate responders.

Results : A total of 41 eyes from 30 patients were included in this study. At 12 months post-injection, group 1 patients had a lower central foveal thickness (CFT, p=0.017) and fewer hyperreflective dots (HRD, p=0.028) compared with group 2. Concerning the response, 30 (73%) patients presented a significant functional improvement with 17 (42%) having an increase of at least 15 ETDRS letters. Lower baseline BCVA and baseline SRF (p=0.036) were associated with an increase of at least 15 ETDRS letters (p=0.012). Overall, 13 (32%) eyes were judged to be good responders and 3 (7%) bad responders; therefore, 61% of eyes had a moderate response. Patients who needed additional therapy had a higher prevalence of subretinal fluid (SRF, 42% vs 3% p=0.005) at baseline.

Conclusions : This study supports the effectiveness of the FAc implant in the treatment of persistent or recurrent DME and reports significant changes in several SD-OCT parameters at 12 months post-FAc injection.

This is a 2021 ARVO Annual Meeting abstract.