Clinical Trials // Diabetic Macular Edema // Past // Roomasa Channa // Aug 24 2021
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
Sponsor: UNITY Biotechnology, Inc.
Principal Investigator: Roomasa Chana
Study Coordinator: Angie Adler
This study is intended to assess the safety, tolerability, and evidence of pharmacodynamic activity of a single intravitreal injection of UBX1325 in patients with diabetic macular edema.
Subjects will be randomized 1:1 into either the UBX1325 or sham study arms and be followed for approximately 24 weeks.
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.
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
Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging