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

July 30, 2024 updated by: Alimera Sciences

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Investigative Site
      • Tucson, Arizona, United States, 85704
        • Investigative Site
    • California
      • Beverly Hills, California, United States, 90211
        • Investigative Site
      • Glendale, California, United States, 91203
        • Investigative Site
      • Laguna Hills, California, United States, 92653
        • Investigative Site
      • Santa Ana, California, United States, 92705
        • Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Investigative Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • Investigative Site
      • Orlando, Florida, United States, 32806
        • Investigative Site
      • Palm Beach Gardens, Florida, United States, 33418
        • Investigative Site
      • Tampa, Florida, United States, 33609
        • Investigative Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Investigative Site
      • Sandy Springs, Georgia, United States, 30328
        • Investigative Site
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Investigative Site
      • Lemont, Illinois, United States, 60439
        • Investigative Site
      • Oak Park, Illinois, United States, 60304
        • Investigative Site
      • Springfield, Illinois, United States, 62704
        • Investigative Site
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Investigative Site
      • Shawnee Mission, Kansas, United States, 66204
        • Investigative Site
    • Louisiana
      • West Monroe, Louisiana, United States, 71291
        • Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Investigative Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Investigative Site
      • Grand Blanc, Michigan, United States, 48439
        • Investigative Site
    • Missouri
      • Independence, Missouri, United States, 64055
        • Investigative Site
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Investigative Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Investigative Site
      • Cincinnati, Ohio, United States, 45242
        • Investigative Site
      • Cleveland, Ohio, United States, 22106
        • Investigative Site
      • Youngstown, Ohio, United States, 44505
        • Investigative Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Investigative Site
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Investigative Site
    • South Carolina
      • Columbia, South Carolina, United States, 29169
        • Investigative Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Investigative Site
      • Houston, Texas, United States, 77030
        • Investigative Site
      • McAllen, Texas, United States, 78503
        • Investigative Site
      • San Antonio, Texas, United States, 72815
        • Investigative Site
      • San Antonio, Texas, United States, 78240
        • Investigative Site
      • The Woodlands, Texas, United States, 77384
        • Investigative Site
    • Virginia
      • Roanoke, Virginia, United States, 24018
        • Investigative Site
      • Warrenton, Virginia, United States, 20186
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

    1. Intravitreal or periocular steroids;
    2. Intravitreal injection of aflibercept, brolucizumab, or conbercept ≤12 months prior to Screening Visit
  6. 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
  7. 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).
  8. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: ILUVIEN Arm
Intravitreal ILUVIEN
Drug: Iluvien 0.19 MG Drug Implant
0.19 mg Fluocinolone Acetonide Intravitreal Implant
Other Names:
  • ILUVIEN
Drug: Aflibercept
2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection
Other Names:
  • Eylea
Active Comparator: Aflibercept Arm
Intravitreal aflibercept
Drug: Aflibercept
2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection
Other Names:
  • Eylea

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The mean total number of supplemental aflibercept injections needed during the study
Time Frame: Baseline to 18 months
The mean total number of supplemental aflibercept injections needed during
Baseline to 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects with 15, 10 and 5 letter (ETDRS) gains from baseline
Time Frame: At 18 months
Proportion of subjects with 15, 10 and 5 letter (ETDRS) gains from baseline
At 18 months
Area under the curve (AUC) of Best Corrected Visual Acuity (BCVA)
Time Frame: Baseline to 18 months
Area under the curve (AUC) of Best Corrected Visual Acuity (BCVA)
Baseline to 18 months
Mean change from baseline in Center Subfield Thickness (CST)
Time Frame: Baseline to 18 months
Mean change from baseline in Center Subfield Thickness (CST)
Baseline to 18 months
Area under the curve (AUC) of Center Subfield Thickness (CST)
Time Frame: Baseline to 18 months
Area under the curve (AUC) of Center Subfield Thickness (CST)
Baseline to 18 months
Mean change from baseline in the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite score and subscale scores
Time Frame: At 18 months
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.
At 18 months
Safety Outcome Endpoints: The incidence and severity of treatment-related adverse events
Time Frame: Baseline to 18 months
The incidence and severity of treatment-related adverse events
Baseline to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alimera Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01-20-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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