Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration

• ClinicalTrials.gov Identifier: NCT04537884
• Recruitment Status: Recruiting
• First Posted: September 3, 2020
• Last Update Posted: January 29, 2021
• Sponsor: Unity Biotechnology, Inc.
• Information provided by (Responsible Party): Unity Biotechnology, Inc.

Study Description

Brief Summary:

A study to evaluate safety, tolerability, and pharmacokinetics of a single intravitreal injection of UBX1325 in patients diagnosed with diabetic macular edema (DME) or neovascular Age-Related Macular Degeneration.

Condition or disease	Intervention/treatment	Phase
Diabetic Macular Edema; Neovascular Age-related Macular Degeneration	Drug: UBX1325	Phase 1

Detailed Description:

This is a Phase 1, open-label, first-in-human (FIH), single-ascending dose (SAD) study consisting of approximately 4 cohorts. The total number of patients will be at least 3 per cohort plus 3 additional patients in the maximum tolerated dose (MTD) cohort. UBX1325 will be administered intravitreally and all patients will be followed for approximately 6 months.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open-Label, Single Ascending Dose Study to Assess the Safety and Tolerability of a Single Intravitreal Injection of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration
• Actual Study Start Date: October 8, 2020
• Estimated Primary Completion Date: April 2021
• Estimated Study Completion Date: October 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment with UBX1325; UBX1325, single intravitreal injection, ascending dose	Drug: UBX1325; Investigational drug intravitreal injection

Outcome Measures

Primary Outcome Measures :

1. Ocular and systemic safety and tolerability of a single intravitreal injection of UBX1325 evaluated by the incidence of dose limiting toxicities (DLTs) and treatment emergent adverse events (TEAEs) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :

1. Plasma concentration of UBX1325 following a single intravitreal injection [ Time Frame: up to 24 hours post dose ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Nonproliferative diabetic retinopathy (DR) patients with DME or patients with nAMD.
• Center-involved DME with central subfield thickness (CST) ≥350 μm on SD-OCT and for nAMD, active choroidal neovascularization (CNV) associated with age-related macular degeneration as evidenced on FA and SD-OCT at Day 1, including presence of intraretinal or subretinal fluid.
• BCVA in the study eye (most affected) of 55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or worse screening and on Day 1.
• Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.

Exclusion Criteria:

• Any ocular/intraocular/periocular infection or inflammation in either eye.
• History of vitreous hemorrhage in the study eye within 2 months prior to screening and subretinal hemorrhage with bleeding area ≥4 disc area in the study eye.
• Any retinovascular disease or retinal degeneration other than DME or nAMD in the study eye.
• History of systemic and intraocular steroid use for 6 months prior to Day 1. The use of intravitreal nonbiodegradable steroid implants (ex. Iluvien®, Yutiq®, Retisert®) is prohibited.
• Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging.
• Any uncontrolled medical condition that, in the opinion of the investigator, would preclude participation in this study.

Contacts and Locations

Contacts

Contact: Medical Monitor; 650-513-0096; UBX1325-01_medicalmonitor@unitybiotechnology.com

Locations

United States, California

Retina-Vitreous Associates Medical Group; Recruiting

Beverly Hills, California, United States, 90211

Salehi Retina Institute; Recruiting

Huntington Beach, California, United States, 92647

United States, Florida

MedEye Associates; Recruiting

Miami, Florida, United States, 33143

Sarasota Retina Institute; Recruiting

Sarasota, Florida, United States, 34239

Center for Retina and Macular Disease; Recruiting

Winter Haven, Florida, United States, 33880

United States, Indiana

MidWest Eye Institute; Recruiting

Indianapolis, Indiana, United States, 46290

United States, Texas

Houston Eye Associates; Recruiting

Houston, Texas, United States, 77025

Medical Center Ophthalmology Associates; Recruiting

San Antonio, Texas, United States, 78240

Sponsors and Collaborators

Unity Biotechnology, Inc.

Investigators

• Study Chair: Jamie Dananberg, MD; UNITY Biotechnology

More Information

• Responsible Party: Unity Biotechnology, Inc.
• ClinicalTrials.gov Identifier: NCT04537884
• Other Study ID Numbers: UBX1325-01
• First Posted: September 3, 2020
• Last Update Posted: January 29, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Unity Biotechnology, Inc.:

Retinal disease; Macular edema; Diabetes mellitus; Diabetic macular edema; Neovascular Age-Related Macular Degeneration

Additional relevant MeSH terms:

Macular Degeneration; Macular Edema; Wet Macular Degeneration; Edema; Retinal Degeneration; Retinal Diseases; Eye Diseases