Author: Susana Penas
Co-authors: Bernardete Pessoa, Carla Teixeira, Joao Paulo Sousa, Miguel Ruao, Angelina Meireles
AbstractPurpose: The RIVER study was designed to assess portuguese real-world outcomes of the ILUVIEN® implant (0.190 mg fluocinolone acetonide, FAc) in treating persistent and recurrent diabetic macular edema (DME). This study sub-analysis aimed to compare the functional and safety outcomes based on baseline visual acuity (VA).
Setting/Venue: The RIVER study retrospectively assessed patient data from 5 portuguese centers; it was approved by the Ethics Committees (EC) from all the involved centers and was carried out in collaboration with the Retina Study Group (GER) and designed to audit the patient's electronic medical records (EMR) using the database Retina.PT.
Methods: The RIVER study collected data from 222 eyes of 152 patients with persistent and recurrent DME; data on patients’ records from the last 12 months prior to treatment with the ILUVIEN® implant to > 6 months after its implantation was collected; the mean follow-up time after ILUVIEN® was 22.5 ± 9.0 months Twenty-four eyes were excluded in this sub-analysis due to a missing register on baseline VA. Eyes were divided into three major groups according to their baseline VA score (group A: <50 ETDRS letters (n=84), group B: 50-60 ETDRS letters (n=68) and group C: >60 ETDRS letters (n=46). The effect of the implant on best corrected visual acuity (BCVA), central foveal thickness (CFT) and intraocular pressure (IOP) was compared between groups at similar timelines over 36 months. Statistical analysis was performed using IBM SPSS version 28 and Microsoft Excel software.
Results: Baseline demographic characteristics were similar among the 3 groups except for CFT: 524.7 ± 193.7 µm (A), 457.1 ± 108.0 µm (B) and 414.4 ± 138.4 µm (C), (p<0.01). Mean age was 72.2 ± 8.7, 70.4 ± 8.6 and 71.7 ± 8.9 years in group A, B and C, respectively (p=0.979) and mean duration of DME was 4.6 ± 2.9 (A), 4.8 ± 2.9 (B) and 5.1 ± 2.7 years (C) (p=0.844). Mean baseline BCVA was 31.7 ± 10.7 (A), 54.5 ± 4.3 (B) and 69.6 ± 5.0 (C) (p<0.001). A greater VA gain was observed for groups with lower baseline VA: +13 letters (A) (p<0.001), +8 letters (B) (p<0.001) and was kept the same (70 letters) in group C (p=0.665). A more significant reduction in CFT was also observed for the groups with lower baseline VA: -176.0 µm (A) (p<0.001), -148.3 µm (B) (p<0.001), and -45.6 µm (C) (p=0.049). Group C, including eyes with higher baseline VA experienced a ceiling effect enabling a greater gain, as well as preventing a greater reduction in CFT, as they already presented thinner retinas at baseline. Mean IOP remained stable during follow-up (Δ +0.74 mmHg (A), +0.59 mmHg (B) and +0.45 mmHg(C) (p>0.05).
Conclusions (200 words): This sub-analysis from the RIVER study enhances the long-term effectiveness and safety of the fluocinolone acetonide implant for the treatment of persistent and recurrent DME in routine clinical practice in Portugal, regardless of baseline visual acuity. Patients with better vision at baseline maintained their good vision, close to 70 ETDRS letters, throughout the follow-up period, implying that this implant satisfies the DME treatment goal of maintaining or improving vision as a long-term outcome.
Financial Disclosures: Susana Penas - consultant for Alimera, Bayer, Novartis, Roche