McAllen, Texas 78503

  • Diabetic Macular Edema (DME)

Purpose:

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)


Study summary:

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.


Criteria:

Inclusion Criteria: - Patients aged ≥ 18 years. - Nonproliferative diabetic retinopathy (DR) patients with DME who had at least 3 anti-VEGF treatments in the preceding 6 months prior to Day 1, with the last anti-VEGF given between 3 and 5 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. - 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


NCT ID:

NCT04857996


Primary Contact:

Medical Monitor
Phone: 650-513-0096
Email: UBX1325_medicalmonitor@unitybiotechnology.com


Backup Contact:

N/A


Location Contact:

McAllen, Texas 78503
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 26, 2021

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