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Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD)

NCT04857996 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-05-16

Study results available
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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).

Conditions

  • Diabetic Macular Edema (DME)

Interventions

DRUG

UBX1325

Patients will be administered a single 50 μL UBX1325 IVT injection

OTHER

Sham

Sham procedure

Sponsors & Collaborators

  • Unity Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Sharon Klier, MD, MPH · Unity Biotechnology, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-25
Primary Completion
2023-04-06
Completion
2023-04-06
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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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 NCT04857996 on ClinicalTrials.gov