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NCT04857996 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD)
A Phase 2 study, sponsored by Unity Biotechnology.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT04857996: Completed Phase 2 study, sponsored by Unity Biotechnology.
NCT04857996 is a Phase 2 study that has completed, run by Unity Biotechnology. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04857996, a Phase 2 study, has completed, sponsored by Unity Biotechnology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study Summary
This study is intended to assess the exposure, safety, biological activity, and durability of UBX1325, a phosphate pro-drug, and its active parent molecule (UBX0601) following a single intravitreal (IVT) injection of UBX1325 in patients with diabetic macular edema (DME).
Primary Outcome
The systemic safety and tolerability is evaluated by incidence of Treatment Emergent Adverse Events (TEAEs) by System organ class Preferred Term.
Interventions
- OTHER Sham
- DRUG UBX1325
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2021-06-25 |
| Est. Completion | 2023-04-06 |
| Phase | Phase 2 |
What the finished NCT04857996 record still lists
NCT04857996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT04857996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04857996 about?
NCT04857996 is a clinical study titled "Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD)". This study is intended to assess the exposure, safety, biological activity, and durability of UBX1325, a phosphate pro-drug, and its active parent molecule (UBX0601) following a single intravitreal (IVT) injection of UBX1325 in patients with diabetic macular edema (DME).
What is the current status of trial NCT04857996?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2021-06-25. Estimated completion is 2023-04-06.
What interventions are being tested in trial NCT04857996?
The interventions under investigation include: Sham (OTHER), UBX1325 (DRUG).
Who is sponsoring clinical trial NCT04857996?
This trial is sponsored by Unity Biotechnology, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04857996's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 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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