MedTrace Logo

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

NCT06011798 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-08-05

Study results available
· View outcomes & findings →

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

Conditions

Interventions

DRUG

Aflibercept

Anti-VEGF control

DRUG

foselutoclax

Experimental drug

Sponsors & Collaborators

  • Unity Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Bhisitkul, MD, Ph.D. · Unity Biotechnology, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-23
Primary Completion
2025-01-21
Completion
2025-04-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06011798 on ClinicalTrials.gov