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A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)
Sponsor: Alimera Sciences
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).
Official title: A Randomized, Masked, Controlled Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2020-08-31
Completion Date
2024-12-31
Last Updated
2024-07-31
Healthy Volunteers
No
Conditions
Interventions
Iluvien 0.19 MG Drug Implant
0.19 mg Fluocinolone Acetonide Intravitreal Implant
Aflibercept
2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection
Locations (40)
Investigative Site
Phoenix, Arizona, United States
Investigative Site
Tucson, Arizona, United States
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Beverly Hills, California, United States
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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
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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
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McAllen, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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The Woodlands, Texas, United States
Investigative Site
Roanoke, Virginia, United States
Investigative Site
Warrenton, Virginia, United States