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

NCT04469595 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 01-20-005
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 40

Brief 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). 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).

Conditions

Diabetic Macular Edema

Keywords

DME; CI-DME; Diabetic Macular Edema; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

  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)

  Baseline to 18 months

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

  At 18 months

Study Arms (2)

ILUVIEN Arm

ACTIVE COMPARATOR

Intravitreal ILUVIEN

Drug: Iluvien 0.19 MG Drug Implant; Drug: Aflibercept

Aflibercept Arm

ACTIVE COMPARATOR

Intravitreal aflibercept

Drug: Aflibercept

Interventions

Iluvien 0.19 MG Drug Implant DRUG

0.19 mg Fluocinolone Acetonide Intravitreal Implant

Also known as: ILUVIEN

ILUVIEN Arm

Aflibercept DRUG

2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection

Also known as: Eylea

Aflibercept Arm; ILUVIEN Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with Proliferative Diabetic Retinopathy (PDR); high risk proliferative diabetic retinopathy in the study eye and related complications.
• 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.
• Other conditions that can cause macular edema.
• 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.
• Patients who received the following therapies in the study eye:
• Intravitreal or periocular steroids;
• Intravitreal injection of aflibercept, brolucizumab, or conbercept ≤12 months prior to Screening Visit
• 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
• 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).

Sponsors & Collaborators

• Alimera Sciences: lead

Study Sites (40)

Investigative Site

Phoenix, Arizona, 85020, United States

Location

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Tucson, Arizona, 85704, United States

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Beverly Hills, California, 90211, United States

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Glendale, California, 91203, United States

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Laguna Hills, California, 92653, United States

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Santa Ana, California, 92705, United States

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Colorado Springs, Colorado, 80909, United States

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Clearwater, Florida, 33761, United States

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Orlando, Florida, 32806, United States

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Palm Beach Gardens, Florida, 33418, United States

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Tampa, Florida, 33609, United States

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Marietta, Georgia, 30060, United States

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Sandy Springs, Georgia, 30328, United States

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Elmhurst, Illinois, 60126, United States

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Lemont, Illinois, 60439, United States

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Oak Park, Illinois, 60304, United States

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Springfield, Illinois, 62704, United States

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Leawood, Kansas, 66211, United States

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Shawnee Mission, Kansas, 66204, United States

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West Monroe, Louisiana, 71291, United States

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Baltimore, Maryland, 21237, United States

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Detroit, Michigan, 48201, United States

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Grand Blanc, Michigan, 48439, United States

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Independence, Missouri, 64055, United States

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Bloomfield, New Jersey, 07003, United States

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Beachwood, Ohio, 44122, United States

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Cincinnati, Ohio, 45242, United States

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Cleveland, Ohio, 22106, United States

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Youngstown, Ohio, 44505, United States

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Tulsa, Oklahoma, 74114, United States

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Erie, Pennsylvania, 16507, United States

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Columbia, South Carolina, 29169, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77030, United States

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McAllen, Texas, 78503, United States

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San Antonio, Texas, 72815, United States

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San Antonio, Texas, 78240, United States

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The Woodlands, Texas, 77384, United States

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Roanoke, Virginia, 24018, United States

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Investigative Site

Warrenton, Virginia, 20186, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Fluocinolone Acetonide; Drug Implants; aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, masked, active-controlled, multi-center study

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 14, 2020
• Study Start: August 31, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (40)