Alimera Sciences, Inc. announced patient enrollment completion for its NEW DAY clinical trial on ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg for diabetic macular edema (DME).
Refresh me on ILUVIEN.
Approved by the FDA in 2014, ILUVIEN is a sustained-release intravitreal implant indicated for DME patients who have already received corticosteroid therapy and did not exhibit a significant increase in intraocular pressure (IOP).
It is also approved in Canada, Kuwait, Lebanon, and the U.A.E., and is marketed with an indication to treat non-infectious posterior uveitis in 17 European countries (not in the U.S.).
How does it work?
The implant is designed to release the corticosteroid fluocinolone acetonide in sub-microgram levels for up to 36 months.
Now talk about the study.
The multicenter, randomized, single-masked, randomized controlled trial (NCT04469595) is generating potential data that will assess ILUVIEN as a baseline treatment for DME as well as advantages over repeat aflibercept (anti-vascular endothelial growth [VEGF]) injections.
And the patients?
An estimated 300 patients across approximately 42 sites in the U.S. have been enrolled.
Patient criteria included those who are either treatment naïve or who have not received any DME treatments 12 months prior to the start of the study.
Those who did receive DME treatment >12 months before screening must not have received >4 intravitreal injections.
How are they randomized?
Patients are being split into two groups to be administered either:
- 5 injections of 2 mg aflibercept at 4-week intervals for 16 weeks as a loading dose.
- 5 injections of ILUVIEN at 4-week intervals for 16 weeks as a loading dose.
Following 16 weeks, both groups are being evaluated every 4 weeks; supplemental aflibercept injections (2 mg / 0.05 mL) are administered only as needed.
Note: The criteria for the supplemental therapy will be determined by the study protocol and identical for both groups.
According to Alimera, the treatment period is 18 months.
What’s being measured?
Primary outcomes include the mean number of supplemental aflibercept needed between treatment groups.
Secondary endpoints are:
- Mean best-corrected visual acuity (BCVA) score
- Time to first supplemental treatment
- Retinal thickness variability measures based on optical coherence tomography (OCT)
- Diabetic retinopathy (DR) scores
Is that it?
Nope! Other data points will include: outcome measures (patient-reported) assessing the effect on their quality of life and level of functioning as well as neuronal functional measures and retinal nerve layer (RNL) OCT imaging measures.
When can we expect results?
According to Clinical Trials, the study is expected to be completed by June 2024. Stay tuned for updates in the meantime!