A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)
NCT ID: NCT04469595
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
300 participants
INTERVENTIONAL
2020-08-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ILUVIEN Arm
Intravitreal ILUVIEN
Iluvien 0.19 MG Drug Implant
0.19 mg Fluocinolone Acetonide Intravitreal Implant
Aflibercept
2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection
Aflibercept Arm
Intravitreal aflibercept
Aflibercept
2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection
Interventions
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Iluvien 0.19 MG Drug Implant
0.19 mg Fluocinolone Acetonide Intravitreal Implant
Aflibercept
2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Alimera Sciences
INDUSTRY
Responsible Party
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Locations
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Investigative Site
Phoenix, Arizona, United States
Investigative Site
Tucson, Arizona, United States
Investigative Site
Beverly Hills, California, United States
Investigative Site
Glendale, California, United States
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Laguna Hills, California, United States
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Santa Ana, California, United States
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Colorado Springs, Colorado, United States
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Clearwater, Florida, United States
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Orlando, Florida, United States
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Palm Beach Gardens, Florida, United States
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Tampa, Florida, United States
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Marietta, Georgia, United States
Investigative Site
Sandy Springs, Georgia, United States
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Elmhurst, Illinois, United States
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Lemont, Illinois, United States
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Oak Park, Illinois, United States
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Springfield, Illinois, United States
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Leawood, Kansas, United States
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Shawnee Mission, Kansas, United States
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West Monroe, Louisiana, United States
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Baltimore, Maryland, United States
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Detroit, Michigan, United States
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Grand Blanc, Michigan, United States
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Independence, Missouri, United States
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Bloomfield, New Jersey, United States
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Beachwood, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Youngstown, Ohio, United States
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Tulsa, Oklahoma, United States
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Erie, Pennsylvania, United States
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Columbia, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
Investigative Site
McAllen, Texas, United States
Investigative Site
San Antonio, Texas, United States
Investigative Site
San Antonio, Texas, United States
Investigative Site
The Woodlands, Texas, United States
Investigative Site
Roanoke, Virginia, United States
Investigative Site
Warrenton, Virginia, United States
Countries
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Other Identifiers
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01-20-005
Identifier Type: -
Identifier Source: org_study_id
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