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

Sponsor

Unity Biotechnology, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05275205

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

1.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated 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

Actual Study Start Date :

Mar 2, 2022

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

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

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

Outcome Measures

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 [24 weeks]
Changes in BCVA from Baseline within group at any or all visits [24 weeks]

Secondary Outcome Measures

Average change in BCVA from Baseline over time [16 and 24 weeks]
Change in CST from Baseline over time as assessed by SD-OCT and read by a Central Reading Center [16 and 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina-Vitreous Associates Medical Group	Beverly Hills	California	United States	90211
2	Salehi Retina Institute	Huntington Beach	California	United States	92647
3	Loma Linda University	Loma Linda	California	United States	92354
4	Cal Retina	Oxnard	California	United States	93036
5	Byers Eye Institute @ Stanford University	Palo Alto	California	United States	94303
6	Bay Area Retina	Walnut Creek	California	United States	94598
7	Advanced Vision Research Institute	Longmont	Colorado	United States	80503
8	Rand Eye Institute	Deerfield Beach	Florida	United States	33603
9	Retina Vitreous Associates of Florida	Tampa	Florida	United States	33607
10	Northwestern University	Chicago	Illinois	United States	60611
11	University Retina and Macula Associates	Lemont	Illinois	United States	69439
12	Illinois Eye Center	Peoria	Illinois	United States	61615
13	Midwest Eye	Indianapolis	Indiana	United States	46290
14	Sabates Eye Centers	Leawood	Kansas	United States	66211
15	Wilmer Eye Institute at John Hopkins University	Baltimore	Maryland	United States	21287
16	Mayo Clinic-Rochester	Rochester	Minnesota	United States	55901
17	Sierra Eye Institute	Reno	Nevada	United States	89502
18	Mid Atlantic Retina	Cherry Hill	New Jersey	United States	08034
19	Western Carolina Clinical Research	Asheville	North Carolina	United States	28803
20	EyeHealth Northwest	Portland	Oregon	United States	97225
21	Retina Research Institution of Texas	Abilene	Texas	United States	79606
22	Retina Consultants of Texas	Bellaire	Texas	United States	77401
23	Valley Retina Institute	McAllen	Texas	United States	78503
24	Austin Retina	Round Rock	Texas	United States	78681
25	Retina Center of Texas	Southlake	Texas	United States	76092

Sponsors and Collaborators

Unity Biotechnology, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Unity Biotechnology, Inc.

ClinicalTrials.gov Identifier:

NCT05275205

Other Study ID Numbers:

UBX1325-03

First Posted:

Mar 11, 2022

Last Update Posted:

May 26, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Unity Biotechnology, Inc.

Wet AMD

Additional relevant MeSH terms:

Macular Degeneration

Wet Macular Degeneration

Aflibercept

Study Results

No Results Posted as of May 26, 2022