Alimera Sciences announces that it has enrolled the first patient in the company’s NEW DAY clinical trial, a randomized, controlled, multicenter study designed to generate prospective data for Iluvien (fluocinolone acetonide intravitreal implant) 0.19 mg as a baseline therapy in patients diagnosed with diabetic macular edema (DME).
“The first patient enrolled in our NEW DAY trial is an important milestone initiating the opportunity to generate data that we believe has the potential to change the paradigm of DME treatment by offering patients a first-line treatment option that can maintain vision longer with fewer injections,” Rick Eiswirth, Alimera’s President and Chief Executive Officer, said in a company news release. “We have great confidence in this study as our FAME Study data supported the approval of Iluvien as first-line therapy in the U.S., and our real-world data from both the U.S. and Europe indicate that the benefits of Iluvien are maximized when used early in DME.”
About the NEW DAY Study
The NEW DAY Study is a multicenter, single-masked, randomized, controlled trial designed to generate prospective data evaluating Iluvien as a baseline therapy in the treatment of DME and demonstrate its potential advantages over the current standard of care of repeat anti-VEGF (afilbercept) injections. The NEW DAY Study is planned to enroll approximately 300 treatment-naïve, or almost naïve, DME patients in approximately 42 sites around the U.S.
Patients who meet the entry criteria will be randomized to receive either five injections of intravitreal aflibercept 2 mg at 4-week intervals for the first 16 weeks as a loading dose or an Iluvien intravitreal implant. After the initial 16-week period, both arms will be 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 will be identical in both treatment arms. The planned treatment period in the study is 18 months. Once the treatment period is concluded, patients will be given the option to participate in an open label extension study for up to 42 months.
The primary outcome measure for NEW DAY 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 up to 18 months, time to first supplemental treatment, retinal thickness amplitude on optical coherence tomography (OCT), and diabetic retinopathy scores. In addition, the study will collect patient-reported outcome measures to evaluate the effect on patients’ quality of life and level of functioning. Exploratory endpoints will include neuronal functional measures and OCT imaging measures of retinal nerve layer thickness.
Full study details are available at https://clinicaltrials.gov