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

• ClinicalTrials.gov Identifier: NCT04537884
• Recruitment Status: Completed
• First Posted: September 3, 2020
• Last Update Posted: March 10, 2022
• 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 in order to address the primary objective. Up to an additional 6 nAMD patients will be enrolled in the highest dose cohort. A single dose of UBX1325 will be administered intravitreally and all patients will be followed for approximately 6 months.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 19 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
• Actual Primary Completion Date: January 25, 2022
• Actual Study Completion Date: January 25, 2022

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

Criteria

Inclusion Criteria:

• nAMD patients who, in the opinion of the Investigator, are inadequately responding to or failed current treatment options.
• 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 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or worse at 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 in the past 4 weeks prior to screening.
• Subretinal hemorrhage with bleeding area ≥4 disc area in the study eye
• Concomitant therapy with anti-VEGF therapies (e.g., Avastin®, Lucentis®, or Eylea®) or previous use of these agents in the study eye within approximately 28 days of study enrollment
• Any retinovascular disease or retinal degeneration other than 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

Locations

United States, California

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States, 90211

Salehi Retina Institute

Huntington Beach, California, United States, 92647

United States, Florida

MedEye Associates

Miami, Florida, United States, 33143

Sarasota Retina Institute

Sarasota, Florida, United States, 34239

Center for Retina and Macular Disease

Winter Haven, Florida, United States, 33880

United States, Indiana

MidWest Eye Institute

Indianapolis, Indiana, United States, 46290

United States, Texas

Houston Eye Associates

Houston, Texas, United States, 77025

Medical Center Ophthalmology Associates

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: March 10, 2022
• Last Verified: March 2022

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