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Phosphate Pro-drug

UBX1325 for Diabetic Macular Edema

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
Awards & highlights

Study Summary

This trial will test the new drug UBX1325 for safety and efficacy in treating DME.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ocular and systemic safety and tolerability of a single IVT injection of UBX1325 evaluated by incidence of treatment emergent adverse events (TEAEs)
Secondary outcome measures
Change in CST area under the curve (AUC) from baseline to each study visit
Change in central subfield thickness (CST) from baseline to each study visit as assessed by spectral domain optical coherence tomography (SD-OCT)
Changes in best corrected visual acuity (BCVA) from Baseline
+2 more

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
597 Total Patients Enrolled
Sharon Klier, MD, MPHStudy DirectorUnity Biotechnology, Inc.
2 Previous Clinical Trials
91 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has UBX1325 met the regulatory requirements of the FDA?

"Analysts at Power have determined UBX1325's safety to be a 2, as it is currently undergoing Phase 2 trials and limited evidence of efficacy has been gathered."

Answered by AI

Are there any opportunities for enrollment in this clinical trial currently?

"Clinicaltrials.gov does not list this trial as actively recruiting patients, which was first made available for public view on June 25th 2021 and last amended April 21st 2022. However, there are 114 other studies that are welcoming participants currently."

Answered by AI

Are there any American hospitals participating in the execution of this research endeavor?

"At present, 36 sites are running this study. These span locations such as Sarasota, Longmont and Vancouver in addition to other cities across the world. To reduce travel burdens if you choose to partake, it is ideal to select a location closeby."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Bascom Palmer Eye Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD)
2021. "Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04857996.
~17 spots leftby Apr 2025
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