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Phosphate Pro-drug

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

Phase 2
Waitlist Available
Research Sponsored by Unity Biotechnology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12, 24 and 48

Summary

This trial tests a new eye injection treatment for patients with diabetic macular edema. The treatment aims to reduce swelling in the retina and improve vision by converting into an active form inside the eye.

Eligible Conditions
  • Diabetic Macular Edema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12, 24 and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12, 24 and 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ocular Safety and Tolerability of a Single IVT Injection of UBX1325
Systemic Safety and Tolerability of a Single IVT Injection of UBX1325.
Secondary study objectives
Changes in Best Corrected Visual Acuity (BCVA) From Baseline

Side effects data

From 2023 Phase 2 trial • 65 Patients • NCT04857996
53%
Diabetic retinal oedema
25%
Conjunctival haemorrhage
13%
COVID-19
9%
Vitreous haemorrhage
6%
Eye irritation
6%
Electrocardiogram abnormal
3%
Macular thickening
3%
Retinal oedema
3%
Cataract subcapsular
3%
Pneumonia
3%
Cellulitis
3%
Ankle fracture
3%
Skin abrasion
3%
Anaemia
3%
Atrial fibrillation
3%
Coronary artery occlusion
3%
Nasopharyngitis
3%
Type 2 diabetes mellitus
3%
Headache
3%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
UBX1325
Sham Control

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: UBX1325Experimental Treatment1 Intervention
Group II: Sham ControlPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UBX1325
2021
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Unity Biotechnology, Inc.Lead Sponsor
8 Previous Clinical Trials
609 Total Patients Enrolled
Sharon Klier, MD, MPHStudy DirectorUnity Biotechnology, Inc.
2 Previous Clinical Trials
103 Total Patients Enrolled
~15 spots leftby Dec 2025
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