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

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: Active, not recruiting
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Iluvien 0.19 MG Drug Implant; Drug: Aflibercept

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ashley Gantt; Phone Number: 6785271332; Email: ashley.gantt@alimerasciences.com

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

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
The mean total number of supplemental aflibercept injections needed during the study	The mean total number of supplemental aflibercept injections needed during	Baseline to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At 18 months
Area under the curve (AUC) of Best Corrected Visual Acuity (BCVA)	Area under the curve (AUC) of Best Corrected Visual Acuity (BCVA)	Baseline to 18 months
Mean change from baseline in Center Subfield Thickness (CST)	Mean change from baseline in Center Subfield Thickness (CST)	Baseline to 18 months
Area under the curve (AUC) of Center Subfield Thickness (CST)	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	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	The incidence and severity of treatment-related adverse events	Baseline to 18 months

Collaborators and Investigators

• Sponsor: Alimera Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Diabetic Macular Edema; Diabetic Retinopathy; DME; CI-DME
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Fluocinolone Acetonide; Aflibercept
• Other Study ID 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