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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04537884
Recruitment Status : Completed
First Posted : September 3, 2020
Last Update Posted : March 10, 2022
Information provided by (Responsible Party):
Unity Biotechnology, Inc.

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.

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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

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537884

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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.
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Study Chair: Jamie Dananberg, MD UNITY Biotechnology
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Responsible Party: Unity Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT04537884    
Other Study ID Numbers: UBX1325-01
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Macular Degeneration
Macular Edema
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases