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NCT06011798 · ClinicalTrials.gov registry record · Phase 2

Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)

A Phase 2 study, sponsored by Unity Biotechnology.

Completed
Registry status
Phase 2
Development phase
52
Enrollment target

NCT06011798: Completed Phase 2 study, sponsored by Unity Biotechnology.

NCT06011798 is a Phase 2 study that has completed, run by Unity Biotechnology. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06011798, a Phase 2 study, has completed, sponsored by Unity Biotechnology.

COMPLETED
Registry status
Phase 2
Development phase
52 participants
Enrollment target

Study Summary

The goal of this clinical trial is to assess the efficacy and safety of multiple doses of foselutoclax (UBX1325) in patients with Diabetic Macular Edema. The main questions the study aims to answer are: * Assess the efficacy of foselutoclax compared to aflibercept * Assess the safety and tolerability of foselutoclax

Primary Outcome

Mean change from baseline to the average of Week 20 and Week 24 in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter

Interventions

  • DRUG Aflibercept
  • DRUG foselutoclax

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2023-08-23
Est. Completion 2025-04-08
Phase Phase 2
Unity Biotechnology

9 total trials

What the finished NCT06011798 record still lists

NCT06011798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).

The record links to 0 conditions, and to 2 interventions - of which Aflibercept is the first listed.

NCT06011798 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06011798 about?

NCT06011798 is a clinical study titled "Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)". The goal of this clinical trial is to assess the efficacy and safety of multiple doses of foselutoclax (UBX1325) in patients with Diabetic Macular Edema. The main questions the study aims to answer are: * Assess the efficacy of foselutoclax compared to aflibercept * Assess the safety and tolerabili...

What is the current status of trial NCT06011798?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2023-08-23. Estimated completion is 2025-04-08.

What interventions are being tested in trial NCT06011798?

The interventions under investigation include: Aflibercept (DRUG), foselutoclax (DRUG).

Who is sponsoring clinical trial NCT06011798?

This trial is sponsored by Unity Biotechnology, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06011798's enrollment target sits among peer trials

52 1181st of 2000 higher than 811 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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Source: ClinicalTrials.gov NCT06011798, the US trial registry maintained by the National Library of Medicine. NCT06011798 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.