ILUVIEN® Implant for Diabetic Macular Edema
(NEW DAY Trial)

Recruiting in Palo Alto (17 mi)

+38 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Alimera Sciences

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for adults over 18 with early Diabetic Macular Edema (DME) confirmed by SD-OCT and specific vision acuity scores. It's not for those with advanced diabetic eye disease, other causes of macular edema, recent certain eye treatments, or uncontrolled glaucoma.

Inclusion Criteria

I am 18 years old or older.

My vision in the study eye is somewhat impaired but not severely.

Must have CI-DME confirmed by Spectral Domain Ocular Coherence Tomography (SD-OCT) and Center Subfield Thickness (CST) of: ≥350 µm in the study eye

Exclusion Criteria

I have or had high eye pressure, glaucoma, or a significant eye condition.

Steroid Challenge Exclusion Criterion- At the Baseline Visit, patients who are determined to have an IOP ≥25 mmHg or an increase ≥8 mmHg from Screening will be excluded from the study.

I have not had certain eye treatments in the past year.

+4 more

Participant Groups

The study compares two DME treatments: an ILUVIEN implant followed by as-needed aflibercept injections versus a series of aflibercept injections alone. The goal is to see if ILUVIEN can be an effective initial treatment.

2Treatment groups

Active Control

Group I: Aflibercept ArmActive Control1 Intervention

Intravitreal aflibercept

Group II: ILUVIEN ArmActive Control2 Interventions

Intravitreal ILUVIEN