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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Macular Edema (DME)

In brief

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).

Key facts

Study ID

NCT04857996

Run by

Unity Biotechnology, Inc.

People needed

65

Starts

2021-06-25

Expected to finish

2023-04-06

Last updated by the study team

2024-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 as determined by a Central Reading Center), who had at least 2 anti-VEGF intravitreal (IVT) injections (one or more of the following 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) ≥300 µm on SD-OCT at Screening
• BCVA in the study eye (most affected) of 73 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening and at Day 1.

You may not qualify if…

• 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 in the past 4 weeks prior to screening
• 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

Where it is running

• Retinal Research Institute, LLC — Phoenix, Arizona, United States
• California Retina Consultants — Bakersfield, California, United States
• The Retina Partners — Encino, California, United States
• Salehi Retina Institute Inc. — Huntington Beach, California, United States
• Loma Linda University — Loma Linda, California, United States
• California Retina Consultants — Oxnard, California, United States
• Advanced Vision Research Institute — Longmont, Colorado, United States
• Bascom Palmer Eye Institute — Miami, Florida, United States
• MedEye Associates — Miami, Florida, United States
• Northwestern Medical Group — Chicago, Illinois, United States
• MidWest Eye Institute — Indianapolis, Indiana, United States
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• Mass Eye and Ear Institute — Boston, Massachusetts, United States
• Sierra Eye Associates — Reno, Nevada, United States
• New York Eye and Ear Infirmary — New York, New York, United States
• EyeHealth Northwest — Portland, Oregon, United States
• Retina Consultants of Carolina, PA — Greenville, South Carolina, United States
• Valley Retina Institute, P.A. — McAllen, Texas, United States
• Retina Center of Texas — Southlake, Texas, United States
• Alberta Retina Research Corporation — Edmonton, Alberta, Canada
• Toronto Retina Institute — North York, Ontario, Canada
• Hopital Maisonneuve-Rosemont — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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