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NCT04469595 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Diabetic Macular Edema, sponsored by Alimera Sciences.

Active
Registry status
Phase 4
Development phase
300
Enrollment target
20
Study locations

NCT04469595 is a Phase 4 study of Diabetic Macular Edema that is active but no longer recruiting, run by Alimera Sciences. The registered enrollment target is 300 participants, below the 3,790-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT04469595, a Phase 4 study of Diabetic Macular Edema, is active but no longer recruiting, sponsored by Alimera Sciences.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
300 participants
Enrollment target
20
Study locations

Study 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 Studied

Diabetic Macular Edema

Interventions

  • DRUG Aflibercept
  • DRUG Iluvien 0.19 MG Drug Implant

Study Locations (20)

California

  • Investigative Site - Beverly Hills
  • Investigative Site - Glendale
  • Investigative Site - Laguna Hills
  • Investigative Site - Santa Ana

Florida

  • Investigative Site - Clearwater
  • Investigative Site - Orlando
  • Investigative Site - Palm Beach Gardens
  • Investigative Site - Tampa

Illinois

  • Investigative Site - Elmhurst
  • Investigative Site - Lemont
  • Investigative Site - Oak Park
  • Investigative Site - Springfield

Arizona

  • Investigative Site - Phoenix
  • Investigative Site - Tucson

Georgia

  • Investigative Site - Marietta
  • Investigative Site - Sandy Springs

Kansas

  • Investigative Site - Leawood
  • Investigative Site - Shawnee Mission

Colorado

  • Investigative Site - Colorado Springs

Louisiana

  • Investigative Site - West Monroe

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2020-08-31
Est. Completion 2024-12-31
Phase Phase 4

Sponsor

Alimera Sciences

8 total trials

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What the Registry Record Tells You About NCT04469595

The ClinicalTrials.gov registry entry for NCT04469595 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,790-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (92% lower). The listed sponsor is Alimera Sciences, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 2 interventions - of which Aflibercept is the first listed.

NCT04469595 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT04469595 about?

NCT04469595 is a clinical study titled "A 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 ...

What is the current status of trial NCT04469595?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2020-08-31. Estimated completion is 2024-12-31.

What conditions does trial NCT04469595 study?

This clinical trial studies the following conditions: Diabetic Macular Edema.

What interventions are being tested in trial NCT04469595?

The interventions under investigation include: Aflibercept (DRUG), Iluvien 0.19 MG Drug Implant (DRUG).

Who is sponsoring clinical trial NCT04469595?

This trial is sponsored by Alimera Sciences, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04469595 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.