NCT04469595

A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)

A Randomized, Masked, Controlled Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Alimera Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Iluvien 0.19 MG Drug Implant	0.19 mg Fluocinolone Acetonide Intravitreal Implant
DRUG	Aflibercept	2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection

Timeline

• Start date: 2020-08-31
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-07-14
• Last updated: 2024-07-31

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study