Alimera enrolls first patient in Iluvien trial
Alimera Sciences has initiated enrollment for its prospective Iluvien study New Day, according to a press release.
The single-masked, randomized, controlled, multicenter study is designed to investigate Iluvien (fluocinolone acetonide intravitreal implant) 0.19 mg as a baseline therapy for patients with diabetic macular edema. The trial plans enrollment of about 300 treatment naive or minimally treated patients at more than 40 sites worldwide.
Patients will receive either five injections of intravitreal aflibercept 2 mg at 4-week intervals for 16 weeks as a loading dose or an Iluvien intravitreal implant. After 16 weeks, both arms will be evaluated every 4 weeks, receiving supplemental aflibercept injections as needed.
The primary endpoint is mean number of supplemental aflibercept injections needed.
Secondary endpoints include best corrected visual acuity up to 18 months, time to first supplemental treatment, retinal thickness amplitude on optical coherence tomography and diabetic retinopathy scores. The study will also include patient-reported outcome measures to investigate effect on patients’ quality of life.
“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, president and CEO, Alimera Sciences, said.