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

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
UBX1325 injection 50 μL
EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Sponsored by
Unity Biotechnology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring Wet AMD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina-Vitreous Associates Medical Group
  • Salehi Retina Institute
  • Advanced Vision Research Institute
  • Rand Eye Institute
  • Retina Vitreous Associates of Florida
  • University Retina and Macula Associates
  • Illinois Eye Center
  • Midwest Eye
  • Mayo Clinic-Rochester
  • Sierra Eye Associates
  • EyeHealth Northwest
  • Retina Research Institution of Texas
  • Valley Retina Institute
  • Austin Retina Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UBX1325

Aflibercept (EYLEA ®)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in best corrected visual acuity (BCVA) from Baseline over time
Change in central subfield thickness (CST) from Baseline over time as assessed by SD-OCT and read by a Central Reading Center
Adverse events (safety)

Full Information

First Posted
February 17, 2022
Last Updated
April 17, 2023
Sponsor
Unity Biotechnology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05275205
Brief Title
Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)
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 Age-Related Macular Degeneration (Wet AMD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Biotechnology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a Phase 2 study. During Screening, every patient will receive a run-in injection of aflibercept. On Day 1, patients will be randomized to either the UBX1325 arm or the aflibercept arm. Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28; and sham procedure on Weeks 8, 16, 24, 32, and 40. Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
Wet AMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
This study is double-masked, masking patients and investigators to treatment assignment. In addition to this, any Clinical Research Organization and Sponsor team members who are actively engaged with the site will be masked. The injector will be unmasked. Some additional roles at the site, Clinical Research Organization and Sponsor levels are unmasked.
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UBX1325
Arm Type
Experimental
Arm Title
Aflibercept (EYLEA ®)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
UBX1325 injection 50 μL
Intervention Description
Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
Intervention Type
Drug
Intervention Name(s)
EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Intervention Description
Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
Primary Outcome Measure Information:
Title
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
Through 24 weeks
Secondary Outcome Measure Information:
Title
Change in best corrected visual acuity (BCVA) from Baseline over time
Time Frame
Through 48 weeks
Title
Change in central subfield thickness (CST) from Baseline over time as assessed by SD-OCT and read by a Central Reading Center
Time Frame
Through 48 weeks
Title
Adverse events (safety)
Time Frame
Through 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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 in the past 12 weeks prior to screening 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
Facility Information:
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Salehi Retina Institute
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Advanced Vision Research Institute
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80503
Country
United States
Facility Name
Rand Eye Institute
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Retina Vitreous Associates of Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
University Retina and Macula Associates
City
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
Country
United States
Facility Name
Illinois Eye Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Midwest Eye
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Mayo Clinic-Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
EyeHealth Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Retina Research Institution of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Austin Retina Associates
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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