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

Neovascular Age-related Macular Degeneration Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05275205
• Other study ID #: UBX1325-03
• Status: Completed
• Phase: Phase 2
• Start date: March 2, 2022
• Est. completion date: July 25, 2023

Study information

• Verified date: October 2023
• Source: Unity Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 25, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• UBX1325 injection 50 µL
Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
• EYLEA® (aflibercept) Injection 2 mg (0.05mL)
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.

Locations

Country	Name	City	State
United States	Retina Research Institution of Texas	Abilene	Texas
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Midwest Eye	Carmel	Indiana
United States	Rand Eye Institute	Deerfield Beach	Florida
United States	Salehi Retina Institute	Huntington Beach	California
United States	University Retina and Macula Associates	Lemont	Illinois
United States	Advanced Vision Research Institute	Longmont	Colorado
United States	Valley Retina Institute	McAllen	Texas
United States	Illinois Eye Center	Peoria	Illinois
United States	EyeHealth Northwest	Portland	Oregon
United States	Sierra Eye Associates	Reno	Nevada
United States	Mayo Clinic-Rochester	Rochester	Minnesota
United States	Austin Retina Associates	Round Rock	Texas
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Unity Biotechnology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Through 24 weeks
Secondary	Change in best corrected visual acuity (BCVA) from Baseline over time		Through 48 weeks
Secondary	Change in central subfield thickness (CST) from Baseline over time as assessed by SD-OCT and read by a Central Reading Center		Through 48 weeks
Secondary	Adverse events (safety)		Through 48 weeks