At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 65 enrolled
Drug / intervention
UBX1325 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2a, Prospective, Multicenter, Randomized, Double Masked, Sham-Controlled Study to Assess the Safety, Tolerability and Evidence of Activity of a Single Intravitreal Injection of UBX1325 in Patients With Diabetic Macular Edema
In Brief
A Phase 2 clinical trial evaluating UBX1325 and Sham for Diabetic Macular Edema (DME). Completed, enrolled 65 participants across 22 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema (DME)
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedApr 2021
Enrollment StartJun 2021
Primary CompletionApr 2023
TodayJul 2026
First PostedApr 23, 2021
Enrollment StartJun 25, 2021
Primary CompletionApr 6, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.2 years ago
Interventions
UBX1325drug
Patients will be administered a single 50 μL UBX1325 IVT injection
Shamother
Sham procedure