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Corticosteroid

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

Phase 4
Waitlist Available
Research Sponsored by Alimera Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects ≥18 years of age at the time of consent
Best Corrected Visual Acuity (BCVA) of ≤80 ETDRS Letters and ≥35 ETDRS letters in the study eye at Screening Visit
Must not have
Patients who have lens opacities due to cataract or other etiologies that would make it difficult to examine the fundus or that affect the patients Activities of Daily Living (ADL)
History or current diagnosis of glaucoma or ocular hypertension (OHT) or a cup to disc ratio >0.8; History of uncontrolled intraocular pressure (defined as IOP ≥25 mmHg with maximum topical and systemic medical hypotensive treatment) or previous filtration surgery in the study eye at Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 18 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether or not a new treatment for DME is better than the standard treatment. It will enroll patients who have not had any DME treatments for the past 12 months, and compare the new treatment to the standard treatment.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include increased eye pressure which could lead to glaucoma, cataract formation, and potential complications related to the injection procedure such as infection or retinal detachment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My vision in the study eye is somewhat impaired but not severely.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cataracts or similar conditions that affect my vision and daily activities.
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I have or had high eye pressure, glaucoma, or a significant eye condition.
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I have not had certain eye treatments in the past year.
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My eye condition is due to advanced diabetic retinopathy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The mean total number of supplemental aflibercept injections needed during the study
Secondary study objectives
Area under the curve (AUC) of Best Corrected Visual Acuity (BCVA)
Area under the curve (AUC) of Center Subfield Thickness (CST)
Mean change from baseline in Center Subfield Thickness (CST)
+3 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Aflibercept ArmActive Control1 Intervention
Intravitreal aflibercept
Group II: ILUVIEN ArmActive Control2 Interventions
Intravitreal ILUVIEN

Find a Location

Who is running the clinical trial?

Alimera SciencesLead Sponsor
13 Previous Clinical Trials
2,659 Total Patients Enrolled
Samer Kaba, MDStudy ChairAlimera Sciences, Inc.

Media Library

Iluvien 0.19 MG Drug Implant (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04469595 — Phase 4
Diabetic Macular Edema Research Study Groups: Aflibercept Arm, ILUVIEN Arm
Diabetic Macular Edema Clinical Trial 2023: Iluvien 0.19 MG Drug Implant Highlights & Side Effects. Trial Name: NCT04469595 — Phase 4
Iluvien 0.19 MG Drug Implant (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04469595 — Phase 4
~6 spots leftby Dec 2024
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