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

  • STATUS
    Recruiting
  • End date
    Jun 16, 2022
  • participants needed
    62
  • sponsor
    Unity Biotechnology, Inc.
Updated on 16 August 2021
Investigator
Medical Monitor
Primary Contact
Northwestern University (7.1 mi away) Contact
+32 other location

Summary

This study is intended to assess the safety, tolerability and evidence of pharmacodynamic activity of a single intravitreal (IVT) injection of UBX1325 in patients with diabetic macular edema (DME)

Description

This is a Phase 2a Proof-of-Concept (POC) study. The study will enroll approximately 62 patients randomized 1:1 into either the UBX1325 or sham study arms, in order to assess the primary objective. All patients will be followed for approximately 24 weeks.

Details
Condition Diabetic Macular Edema
Treatment SHAM, UBX1325
Clinical Study IdentifierNCT04857996
SponsorUnity Biotechnology, Inc.
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged 18 years
Diabetic retinopathy patients (nonproliferative (NPDR) and proliferative (PDR)) with DME (ETDRS-DRSS Score at 65C [or DR severity level of 8] or less severe), who had at least one of 3 anti-VEGF agents: aflibercept, bevacizumab or ranibizumab in the preceding 6 months prior to Day 1, with the last anti-VEGF given between 3 and 6 weeks prior to Day 1
Center-involved DME with central subfield thickness (CST) 350 m on SD-OCT at Screening
BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening and at Day 1

Exclusion Criteria

Concurrent disease in the study eye or structural damage, other than DME, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or color fundus photography (CFP) in the study eye
Any ocular/intraocular/periocular infection or inflammation in either eye
High risk/active PDR, defined as: any vitreous or preretinal hemorrhage, neovascularization elsewhere >1/2 disc area within an area equivalent to standard ETDRS 7-field on clinical examination, or neovascularization of disc >1/3 disc area on clinical examination
History of vitreous hemorrhage in the study eye within 2 months prior to Screening
Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study
Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging
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