Effectiveness and safety of fluocinolone acetonide intravitreal implant in diabetic macular edema patients considered insufficiently responsive to available therapies (REACT): a prospective, non-randomized, and multicenter study

• Published in: International ophthalmology Vol. 43; no. 12; pp. 4639 - 4649
• Main Authors: Ruiz-Moreno, José María, Adán, Alfredo, Lafuente, María, Asencio Durán, Mónica, Arias Barquet, Luís, García Layana, Alfredo, Araiz Iribarren, Javier
• Format: Journal Article
• Language: English
• Published: Dordrecht Springer Netherlands 01.12.2023; Springer Nature B.V
• Subjects: 2016-001680-37; Acuity; Cataracts; Diabetes; Diabetes mellitus; Edema; Effectiveness; EudraCT identifier; Eye; Eye (anatomy); Medicine; Medicine & Public Health; Observational studies; Ophthalmology; Original Paper; Patients; Population studies; Safety; Corticoids; Fluocinolone acetonide intravitreal implant; VEGF inhibitors; Diabetic macular edema
• ISSN: 1573-2630; 0165-5701; 1573-2630
• DOI: 10.1007/s10792-023-02864-2

Objective To assess the effectiveness and safety of the intravitreal fluocinolone-acetonide implant (FAc-i) in patients with chronic diabetic macular edema who did not sufficiently respond to other available therapies. Methods This was a multicenter, prospective, non-randomized, and phase-IV observational study conducted on patients with recurrent-DME who were insufficient responders to currently available therapies (REACT-Study). The primary end-point was the mean change in best-corrected-visual-acuity from baseline to month-24 values. Results Thirty-one eyes from 31 patients were included in the study. Mean age was 68.0 ± 7.7 years, and 10 (32.3%) were women. Study patients had received 5.3 ± 7.3 previous DME treatments before starting the study. In the overall study sample, BCVA improved from 56.1 ± 12.3 letters at baseline to 62.4 ± 17.0 letters at month-24 ( p  = 0.0510). The eyes with a baseline BCVA < 70 ETDRS letters had a significant improvement in BCVA from 53.2 ± 10.2 letters at baseline to 61.5 ± 17.9 letters at month-24 ( p  = 0.0165). In the overall study population, central-subfoveal-thickness (CST) was significantly reduced from 474.0 ± 135.1 µm at baseline to 333.4 ± 135.6 at month-24 ( p  < 0.0001). Similarly, macular-volume (MV) was significantly reduced from 10.7 ± 2.7 mm 3 at baseline to 9.6 ± 2.9 mm 3 ( p  = 0.0027) at month-24. Among the 31 study eyes, 19 (61.3%) required an additional treatment for DME. Throughout the study, 9 (29.0%) eyes required ocular hypotensive medication for controlling their intraocular-pressure and 5 (16.1%) eyes underwent cataract surgery. Conclusions In DME eyes who did not sufficiently respond to previous therapies, the FAc-i was associated with an improvement in visual and anatomic outcomes. There were no unexpected adverse-events. Trial registration number EudraCT identifier: 2016-001680-37.