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NCT04418427 · ClinicalTrials.gov registry record · Phase 2
ADVM-022 Intravitreal Gene Therapy for DME
A Phase 2 study, sponsored by Adverum Biotechnologies.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT04418427: Completed Phase 2 study, sponsored by Adverum Biotechnologies.
NCT04418427 is a Phase 2 study that has completed, run by Adverum Biotechnologies. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04418427, a Phase 2 study, has completed, sponsored by Adverum Biotechnologies.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
A Phase 2, Multi-Center, Randomized, Double-Masked\*, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema \[INFINITY\]
Primary Outcome
Time to worsening of DME disease activity in the study eye through 96 weeks. Time to worsening of DME disease activity defined by either: An increase in CST \> 50 µm as assessed by SD-OCT compared to the lower of the two CST measurements recorded at Day 1 or Week 4; A loss of \> 5 letters in BCVA due to worsening DME disease activity compared to the higher of the two BCVA measurements recorded at Day 1 or Week 4. Number of weeks was relative to Day 1.
Interventions
- BIOLOGICAL Aflibercept
- BIOLOGICAL 6E11 vg/eye of ADVM-022
- BIOLOGICAL 2E11 vg/eye of ADVM-022
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-05-28 |
| Est. Completion | 2023-06-14 |
| Phase | Phase 2 |
What the finished NCT04418427 record still lists
NCT04418427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Aflibercept is the first listed.
NCT04418427 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04418427 about?
NCT04418427 is a clinical study titled "ADVM-022 Intravitreal Gene Therapy for DME". A Phase 2, Multi-Center, Randomized, Double-Masked\*, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema \[INFINITY\]
What is the current status of trial NCT04418427?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2020-05-28. Estimated completion is 2023-06-14.
What interventions are being tested in trial NCT04418427?
The interventions under investigation include: Aflibercept (BIOLOGICAL), 6E11 vg/eye of ADVM-022 (BIOLOGICAL), 2E11 vg/eye of ADVM-022 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04418427?
This trial is sponsored by Adverum Biotechnologies, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04418427's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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