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

Phase 2

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: UBX1325 injection 50 μL; Drug: EYLEA® (aflibercept) Injection 2 mg (0.05mL)

• Registration Number: NCT05275205
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-03-01
• Study Start: 2022-03-02
• Study First Posted: 2022-03-11
• Primary Completion: 2023-02-15
• Study Completion: 2023-07-25
• Status Verified: 2023-10
• Results First Submitted: 2024-07-12
• Results First Submitted QC: 2024-07-12
• Last Update Submitted: 2024-07-12
• Results First Posted: 2024-08-07
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UBX1325	UBX1325 injection 50 μL	-
Aflibercept (EYLEA ®)	EYLEA® (aflibercept) Injection 2 mg (0.05mL)	-

Primary Outcome Measures

Name	Time	Method
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	Ocular and systemic safety and tolerability of a repeat IVT injection of UBX1325 compared to active-control (aflibercept) evaluated by treatment emergent adverse events (TEAEs) through Week 24

Secondary Outcome Measures

Name	Time	Method
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time	Through 48 weeks	BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart starting at 4 meters.
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center	Through 48 weeks	Central Subfield Thickness (CST) measured in microns using spectral domain optical coherence tomography (SD-OCT).
Adverse Events (Safety)	Through 48 weeks	Safety is evaluated by incidence of Treatment Emergent Adverse Events (TEAEs).

Trial Locations

Locations (14)

University Retina and Macula Associates; 🇺🇸 Lemont, Illinois, United States

Valley Retina Institute; 🇺🇸 McAllen, Texas, United States

Retina Vitreous Associates of Florida; 🇺🇸 Saint Petersburg, Florida, United States

Salehi Retina Institute; 🇺🇸 Huntington Beach, California, United States

Retina Research Institution of Texas; 🇺🇸 Abilene, Texas, United States

Illinois Eye Center; 🇺🇸 Peoria, Illinois, United States

Mayo Clinic-Rochester; 🇺🇸 Rochester, Minnesota, United States

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Advanced Vision Research Institute; 🇺🇸 Longmont, Colorado, United States

Rand Eye Institute; 🇺🇸 Deerfield Beach, Florida, United States

EyeHealth Northwest; 🇺🇸 Portland, Oregon, United States

Austin Retina Associates; 🇺🇸 Round Rock, Texas, United States

Midwest Eye; 🇺🇸 Carmel, Indiana, United States

Sierra Eye Associates; 🇺🇸 Reno, Nevada, United States