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Trial record 3 of 3 for:    ubx1325

Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (AMD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05275205
Recruitment Status : Recruiting
First Posted : March 11, 2022
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Unity Biotechnology, Inc.

Brief Summary:
This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Drug: UBX1325 Drug: EYLEA® (aflibercept) Injection 2 mg (0.05mL) Phase 2

Detailed Description:
This is a Phase 2 Proof-of-Concept (POC) study. A total of approximately 46 patients will be enrolled. During Screening, every patient will receive a run-in injection of aflibercept. On Day 1, patients will be randomized to either the two-dose UBX1325 (4-week interval) or active control (aflibercept every 8 weeks) study arm, in order to assess the primary and secondary objectives. All patients will be followed for approximately 24 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:

This study is double-masked, masking patients and investigators to treatment assignment. Other roles at the site, Clinical Research Organization and Sponsor levels are unmasked.

The injector will be unmasked.

Primary Purpose: Treatment
Official Title: A Phase 2, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Safety, Tolerability, and Evidence of Activity of a Repeat Intravitreal Injection of UBX1325 in Patients With Neovascular AMD
Estimated Study Start Date : March 31, 2022
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UBX1325 Drug: UBX1325
Patients will be administered 50 μL of UBX1325, two doses at a 4-week interval

Active Comparator: Aflibercept (EYLEA ®) Drug: EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Patients will be administered aflibercept every 8 weeks




Primary Outcome Measures :
  1. Treatment emergent adverse events (TEAEs) will be evaluated for ocular and systemic safety and tolerability of a repeat IVT injection of UBX1325 compared to active control [ Time Frame: 24 weeks ]
  2. Changes in BCVA from Baseline within group at any or all visits [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Average change in BCVA from Baseline over time [ Time Frame: 16 and 24 weeks ]
  2. Change in CST from Baseline over time as assessed by SD-OCT and read by a Central Reading Center [ Time Frame: 16 and 24 weeks ]


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
Criteria

Inclusion Criteria:

  • Patients aged ≥50 years.
  • Active CNV associated with age-related macular degeneration as evidenced on FA and SD-OCT with presence of intraretinal or subretinal fluid at Screening and Day 1
  • BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening.
  • 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:

  • Concurrent disease in the study eye or structural damage, other than wet AMD, 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 CFP in the study eye.
  • Any ocular/intraocular/periocular infection or inflammation in either eye
  • Subretinal hemorrhage with bleeding area of 4 or greater disc area in the study eye
  • 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

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): NCT05275205


Contacts
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Contact: Sharon Klier, MD, MPH (Medical Monitor) 650-513-0096 UBX1325_medicalmonitor@unitybiotechnology.com

Locations
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Sponsors and Collaborators
Unity Biotechnology, Inc.
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Responsible Party: Unity Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT05275205    
Other Study ID Numbers: UBX1325-03
First Posted: March 11, 2022    Key Record Dates
Last Update Posted: March 11, 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.:
Wet AMD
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents