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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: Active Phase 4 study of Diabetic Macular Edema, sponsored by Alimera Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The mean total number of supplemental aflibercept injections needed during
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2020-08-31 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 4 |
What the registry record for NCT04469595 still lists
NCT04469595 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 3,790-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (92% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04469595's enrollment target sits among peer trials
300 14th of 63 higher than 49 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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