Recently, pharmaceutical company Alimera Sciences announced that the first patient was enrolled in the NEW DAY clinical trial to test ILUVIEN as a potential treatment for patients with diabetic macular edema (DME). This trial aims to determine whether ILUVIEN (fluocinolone acetonide intravitreal implant) could be a potential first-line treatment for patients that improves vision and is more easily accessible than alternate treatments.
ILUVIEN
What is ILUVIEN 0.19 mg and how does it work? The therapy is implanted intravitreally, meaning it is injected directly into the eye. Just one injection can offer up to 3 years of treatment by continuously releasing small amounts of fluocinolone acetonide into the eye. This allows patients to uphold their vision and prevent rapid vision loss without frequent or recurrent treatments.
In the NEW DAY clinical trial, researchers will determine the safety, efficacy, tolerability, and benefits of ILUVIEN compared to aflibercept, the current injectable solution. Altogether, 300 patients with treatment-averse DME will enroll. Patients will receive either ILUVIEN or 5 injections of 2mg aflibercept every 4 weeks for a 4-month period. Next, researchers will compare the results and patients may receive more injections if needed. Ultimately, the NEW DAY trial will last for 1.5 years.
Researchers hope to test how many aflibercept injections are needed, how vision improves, patient quality of life (QOL), and retinal health.
Diabetic Macular Edema
According to the Mayo Clinic, diabetic macular edema (DME) is a complication of diabetic retinopathy. The retinopathy occurs when too high blood sugar damages or blocks blood vessels in your retina. DME then happens when:
tiny bulges (micro aneurysms) protrude from the vessel walls, leaking or oozing fluid and blood into the retina. This fluid can cause swelling (edema) in the central part of the retina (macula).
An estimated 28% of patients with diabetes have related vision problems. Addition risk factors include high blood pressure, high fat levels in the blood, and fluid retention. Patients with DME may experience blurry or double vision, floaters, and vision loss. Learn more about diabetic macular edema.
