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Diabetic Macular EdemaPhase 4NEW DAYNCT04469595

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

A Phase 4 study testing Iluvien 0.19 MG Drug Implant and Aflibercept in people with Diabetic Macular Edema, run by Alimera Sciences at 40 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Iluvien 0.19 MG Drug Implant and Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
40 sitesUnited States
Study dates
31 Aug 2020to 31 Dec 2024
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Major Inclusion Criteria:

  1. Male or female subjects ≥18 years of age at the time of consent.
  2. 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.
  3. Best Corrected Visual Acuity (BCVA) of ≤80 ETDRS Letters and ≥35 ETDRS letters in the study eye at Screening Visit.

Major Exclusion Criteria:

  1. Patients with Proliferative Diabetic Retinopathy (PDR); high risk proliferative diabetic retinopathy in the study eye and related complications.
  2. 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.
  3. Other conditions that can cause macular edema.
  4. Patients who received prior LASER photocoagulation therapy including macular grid or pan retina photocoagulation (PRP) at any time in the study eye. Prior focal LASER photocoagulation therapy outside the macula is allowed.
  5. Patients who received the following therapies in the study eye:
  6. Intravitreal or periocular steroids;
  7. Intravitreal injection of aflibercept, brolucizumab, or conbercept ≤12 months prior to Screening Visit
  8. Patients who received >1 intravitreal injection of ranibizumab or bevacizumab in the last 12 months; or have received ranibizumab or bevacizumab ≤6 weeks prior to Screening Visit
  9. 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).
  10. 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.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Investigative Site

    Baltimore, Maryland, 21237

  • Investigative Site

    Beachwood, Ohio, 44122

  • Investigative Site

    Beverly Hills, California, 90211

  • Investigative Site

    Bloomfield, New Jersey, 07003

  • Investigative Site

    Cincinnati, Ohio, 45242

  • Investigative Site

    Clearwater, Florida, 33761

  • Investigative Site

    Cleveland, Ohio, 22106

  • Investigative Site

    Colorado Springs, Colorado, 80909

  • Investigative Site

    Columbia, South Carolina, 29169

  • Investigative Site

    Dallas, Texas, 75231

  • Investigative Site

    Detroit, Michigan, 48201

  • Investigative Site

    Elmhurst, Illinois, 60126

  • Investigative Site

    Erie, Pennsylvania, 16507

  • Investigative Site

    Glendale, California, 91203

  • Investigative Site

    Grand Blanc, Michigan, 48439

  • Investigative Site

    Houston, Texas, 77030

  • Investigative Site

    Independence, Missouri, 64055

  • Investigative Site

    Laguna Hills, California, 92653

  • Investigative Site

    Leawood, Kansas, 66211

  • Investigative Site

    Lemont, Illinois, 60439

  • Investigative Site

    Marietta, Georgia, 30060

  • Investigative Site

    McAllen, Texas, 78503

  • Investigative Site

    Oak Park, Illinois, 60304

  • Investigative Site

    Orlando, Florida, 32806

  • Investigative Site

    Palm Beach Gardens, Florida, 33418

  • Investigative Site

    Phoenix, Arizona, 85020

  • Investigative Site

    Roanoke, Virginia, 24018

  • Investigative Site

    San Antonio, Texas, 72815

  • Investigative Site

    San Antonio, Texas, 78240

  • Investigative Site

    Sandy Springs, Georgia, 30328

  • Investigative Site

    Santa Ana, California, 92705

  • Investigative Site

    Shawnee Mission, Kansas, 66204

  • Investigative Site

    Springfield, Illinois, 62704

  • Investigative Site

    Tampa, Florida, 33609

  • Investigative Site

    The Woodlands, Texas, 77384

  • Investigative Site

    Tucson, Arizona, 85704

  • Investigative Site

    Tulsa, Oklahoma, 74114

  • Investigative Site

    Warrenton, Virginia, 20186

  • Investigative Site

    West Monroe, Louisiana, 71291

  • Investigative Site

    Youngstown, Ohio, 44505

Other trials in United States

About this study

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

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).

Being tested
Iluvien 0.19 MG Drug Implant, Aflibercept
Keywords
DME, CI-DME, Diabetic Macular Edema, Diabetic Retinopathy
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iluvien 0.19 MG Drug ImplantDrug

    Also called ILUVIEN

    0.19 mg Fluocinolone Acetonide Intravitreal Implant

  • AfliberceptDrug

    Also called Eylea

    2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection

Study groups in NCT04469595
Study groupRoleWhat they receive
ILUVIEN ArmActive comparatorIntravitreal ILUVIEN
Receives: Drug: Iluvien 0.19 MG Drug Implant; Drug: Aflibercept
Aflibercept ArmActive comparatorIntravitreal aflibercept
Receives: Drug: Aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The mean total number of supplemental aflibercept injections needed during the study

    The mean total number of supplemental aflibercept injections needed during

    Measured: Baseline to 18 months

Secondary outcomes (6)

  1. Proportion of subjects with 15, 10 and 5 letter (ETDRS) gains from baseline

    Proportion of subjects with 15, 10 and 5 letter (ETDRS) gains from baseline

    Measured: At 18 months

  2. Area under the curve (AUC) of Best Corrected Visual Acuity (BCVA)

    Area under the curve (AUC) of Best Corrected Visual Acuity (BCVA)

    Measured: Baseline to 18 months

  3. Mean change from baseline in Center Subfield Thickness (CST)

    Mean change from baseline in Center Subfield Thickness (CST)

    Measured: Baseline to 18 months

  4. Area under the curve (AUC) of Center Subfield Thickness (CST)

    Area under the curve (AUC) of Center Subfield Thickness (CST)

    Measured: Baseline to 18 months

  5. Mean change from baseline in the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite score and subscale scores

    The NEI VFQ-25 is a questionnaire that allows the individual to report on their level of visual function. Scores range from 0-100, with a score of 0 being the worst outcome and 100 being the best outcome.

    Measured: At 18 months

  6. Safety Outcome Endpoints: The incidence and severity of treatment-related adverse events

    The incidence and severity of treatment-related adverse events

    Measured: Baseline to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2020
  2. Study start31 Aug 2020
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, masked, active-controlled, multi-center study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04469595
Sponsor's protocol ID
01-20-005
Acronym
NEW DAY
Status last verified
Jul 2024
First submitted
9 Jul 2020
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Singer MA, Wykoff CC, Riemann CD, Gonzalez VH, Weng CY, Alkhatib K, Amarshi RA, Moody S, Pao M. Fluocinolone Acetonide Implant as a Baseline Therapy for Diabetic Macular Edema: Results from the Randomized Phase 4 NEW DAY Study. Ophthalmology. 2026 Jul;133(7):837-851. doi: 10.1016/j.ophtha.2026.03.019. Epub 2026 Mar 25.

    PubMed 41887289

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Iluvien 0.19 MG Drug Implant and Aflibercept in people with Diabetic Macular Edema, run by Alimera Sciences at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The mean total number of supplemental aflibercept injections needed during the study (time frame: Baseline to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04469595, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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