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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Unity Biotechnology, Inc.

Criteria

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 µm 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.

• 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

• Any ocular/intraocular/periocular infection or inflammation in either eye

• 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