According to the company, the study has now reached its goal of 300 patients enrolled to evaluate ILUVIEN as a first line, baseline therapy for DME.
Alimera Sciences, Inc. announced it has completed enrollment for the company’s NEW DAY clinical trial (NCT04469595), a randomly assigned, controlled, multi-center study designed to generate prospective data for fluocinolone acetonide intravitreal implant (ILUVIEN) 0.19 mg as a baseline therapy in patients diagnosed with diabetic macular edema (DME).
Rick Eiswirth, Alimera’s president and CEO said the company believes the study is the largest head-to-head comparison of any corticosteroid therapy and anti-VEGF therapy in the treatment of newly diagnosed patients suffering from DME.
“From this study, we look forward to sharing data in early 2025, which we expect will support a change to the current paradigm of DME treatment, offering patients a first-line treatment option that can maintain vision longer with fewer injections than other therapies,” he said in a news release. “We continue to have great confidence in this study as our most recent PALADIN data further indicated that the benefits of ILUVIEN are realized earlier when used early in DME treatment. We would like to thank all the investigators, staff and patients who are participating in our NEW DAY Study.”
According to the company, the NEW DAY study is a multicenter, single-masked, randomized, controlled trial designed to generate prospective data evaluating fluocinolone acetonide intravitreal implant as a baseline therapy in the treatment of DME and demonstrate its potential advantages over the current standard of care of repeat anti-VEGF (aflibercept) injections. The NEW DAY study currently has enrolled approximately 300 treatment-naïve, or near naïve, DME patients in approximately 42 sites around the U.S.
Patients who meet the entry criteria are randomized to receive either 5 injections of intravitreal aflibercept 2 mg at four-week intervals for the first 16 weeks as a loading dose or an ILUVIEN intravitreal implant. After the initial 16-week period, both arms are evaluated every 4 weeks and receive supplemental intravitreal injections of aflibercept 2 mg only as needed. Criteria for supplemental treatment is set by protocol and identical in both treatment arms. The treatment period in the study is 18 months.
According to the company, the primary outcome measure for the NEW DAY study is the mean number of supplemental aflibercept injections needed during the trial between treatment groups. Key secondary endpoints include mean best corrected visual acuity (BCVA) score over time, time to first supplemental treatment, measures of retinal thickness variability based on optical coherence tomography (OCT), and diabetic retinopathy scores. In addition, the study will collect patient-reported outcome measures evaluating the effect on patients’ quality of life and level of functioning.
The company noted exploratory endpoints include neuronal functional measures and OCT imaging measures of retinal nerve layer thickness.