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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Alimera Sciences
Study ID
NCT04469595
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Iluvien 0.19 MG Drug Implant — DRUG
    0.19 mg Fluocinolone Acetonide Intravitreal Implant
  • Aflibercept — DRUG
    2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection

Study Details

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).

Key Dates

Start date
Aug 31, 2020
Status verified
Jul 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ILUVIEN Arm
    Intravitreal ILUVIEN
  • Active Comparator: Aflibercept Arm
    Intravitreal aflibercept

Primary Outcome Measure

The mean total number of supplemental aflibercept injections needed during the study [ Time Frame: Baseline to 18 months ]

Locations (40)

FacilityCityStateZIPSite coordinators
Investigative SitePhoenixArizona85020-
Investigative SiteTucsonArizona85704-
Investigative SiteBeverly HillsCalifornia90211-
Investigative SiteGlendaleCalifornia91203-
Investigative SiteLaguna HillsCalifornia92653-
Investigative SiteSanta AnaCalifornia92705-
Investigative SiteColorado SpringsColorado80909-
Investigative SiteClearwaterFlorida33761-
Investigative SiteOrlandoFlorida32806-
Investigative SitePalm Beach GardensFlorida33418-
Investigative SiteTampaFlorida33609-
Investigative SiteMariettaGeorgia30060-
Investigative SiteSandy SpringsGeorgia30328-
Investigative SiteElmhurstIllinois60126-
Investigative SiteLemontIllinois60439-
Investigative SiteOak ParkIllinois60304-
Investigative SiteSpringfieldIllinois62704-
Investigative SiteLeawoodKansas66211-
Investigative SiteShawnee MissionKansas66204-
Investigative SiteWest MonroeLouisiana71291-
Investigative SiteBaltimoreMaryland21237-
Investigative SiteDetroitMichigan48201-
Investigative SiteGrand BlancMichigan48439-
Investigative SiteIndependenceMissouri64055-
Investigative SiteBloomfieldNew Jersey07003-
Investigative SiteBeachwoodOhio44122-
Investigative SiteCincinnatiOhio45242-
Investigative SiteClevelandOhio22106-
Investigative SiteYoungstownOhio44505-
Investigative SiteTulsaOklahoma74114-
Investigative SiteEriePennsylvania16507-
Investigative SiteColumbiaSouth Carolina29169-
Investigative SiteDallasTexas75231-
Investigative SiteHoustonTexas77030-
Investigative SiteMcAllenTexas78503-
Investigative SiteSan AntonioTexas72815-
Investigative SiteSan AntonioTexas78240-
Investigative SiteThe WoodlandsTexas77384-
Investigative SiteRoanokeVirginia24018-
Investigative SiteWarrentonVirginia20186-

Find similar trials in Phoenix, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Investigative Site· Phoenix, AZInvestigative Site· Tucson, AZInvestigative Site· Beverly Hills, CAInvestigative Site· Glendale, CAInvestigative Site· Laguna Hills, CAInvestigative Site· Santa Ana, CA

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