A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
This is a randomized, masked, active-controlled, parallel-group, multi-center study that will
assess the efficacy of ILUVIEN as a baseline therapy in the treatment of Center Involving DME
(CI-DME). The study will enroll patients who are either treatment naïve or have not received
any DME treatments for the preceding 12 months as documented in medical records. Patients who
received DME treatment >12 months before screening, must not have received >4 intravitreal
injections. The study will compare 2 treatment regimens: ILUVIEN intravitreal implant (0.19
mg) followed by supplemental aflibercept as needed per protocol criteria (2 mg/0.05 mL),
compared to intravitreal aflibercept loading dose (2 mg administered by intravitreal
injection every 4 weeks for 5 consecutive doses) followed by supplemental aflibercept as
needed per protocol criteria (2 mg/0.05 mL).