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    2. 38. Internationaler Kongress der Deutschen Ophthalmochirurgie (DOC)
    3. A randomized, active-controlled clinical trial of fluocinolone acetonide 0.19 mg intravitreal implant for diabetic macular edema: Reductions in injection treatment burden – results from the NEW DAY study
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38. Internationaler Kongress der Deutschen Ophthalmochirurgie (DOC)


18.-20.06.2026
Nürnberg

Meeting Abstract

A randomized, active-controlled clinical trial of fluocinolone acetonide 0.19 mg intravitreal implant for diabetic macular edema: Reductions in injection treatment burden – results from the NEW DAY study

Christopher D. Riemann - Cincinnati Eye Institute, OH, USA
Michael Singer - Medical Center Ophthalmology Associates, Texas, USA
Charles C. Wykoff - Retina Consultants of Texas, Texas, USA
Victor H. Gonzalez - Valley Retina Institute, Texas, USA
Christina Y. Weng - Baylor College of Medicine, Texas, USA
Kamel Alkhatib - ANI Pharmaceuticals Inc., Baudette, MN, USA
Mary Pao - ANI Pharmaceuticals Inc., Baudette, MN, USA

Text

Purpose: NEW DAY was a prospective, randomized, active-controlled, multicenter, phase 4, 18-month study (ClinicalTrials.gov ID NCT04469595). The study assessed the efficacy and safety of the fluocinolone acetonide (FAc; 0.19 mg) intravitreal implant as a baseline therapy in patients with center-involving diabetic macular edema (DME). Here we focus on reducing injection treatment burden.

Methods: The study compared two treatment regimens: FAc implant followed by supplemental aflibercept (AFL; 2 mg/0.05 mL) versus intravitreal AFL loading doses (2 mg every 4 weeks for 5 consecutive doses) followed by supplemental AFL (2 mg/0.05 mL). Inclusion criteria were: adult patients with type 1 or type 2 diabetes, center-involving DME, and treatment naïve or nearly naïve (≤1 intravitreal ranibizumab or bevacizumab injection in the 12 months before screening; or ≤4 intravitreal anti-VEGF injections >12 months before screening). The primary endpoint was the mean number of supplemental AFL injections. Efficacy and safety were assessed in all randomized patients regardless of whether they received treatment.

Results: 517 participants were screened and 306 were randomized. In terms of the primary endpoint, mean (SD) supplemental AFL injections were FAc: 2.4 (3.17), and aflibercept: 2.5 (3.07) (P=0.76). Total number of injections including FAc and AFL loading, were 3.4 (3.17) and 7.2 (3.42) (P<0.001). Time to rescue after the last mandated injection was 185.4 (97.9) and 132.8 (94.0) days (P<0.001), respectively, with a mean difference of 52.6 (96.0) days. In total, 32.5% and 30.3% (P=0.68) of FAc and AFL patients, respectively, received no supplemental injections. BCVA and CST were generally similar between groups. Cataract procedures occurred in 27.9% (FAc) and 6.6% (AFL); IOP increase events (IOP=10 mmHg from baseline) occurred in 15.6% (FAc) and 3.3% (AFL). Incisional surgery for IOP elevation occurred in 1.9% (FAc) and 0.0% (AFL).

Conclusions: F Functional and anatomical measures were non-inferior between FAc and AFL. Injection treatment burden was reduced in the FAc group compared with the AFL group as indicated by the lower total number of injections, and the longer interval between injections. However, the number of patients receiving no supplemental therapy was similar (~one-third) in both FAc and AFL groups. Safety findings were consistent with previous FAc implant studies.