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

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ClinicalTrials.gov Identifier: NCT04537884
Recruitment Status : Recruiting
First Posted : September 3, 2020
Last Update Posted : January 29, 2021
Sponsor:
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. UBX1325 will be administered intravitreally and all patients will be followed for approximately 6 months.

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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

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:   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.

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


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

Locations
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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
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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: January 29, 2021
Last Verified: January 2021
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
Edema
Retinal Degeneration
Retinal Diseases
Eye Diseases