Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration

• Sponsor: Unity Biotechnology, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04537884
• Collaborator: (none)
• Enrollment: 19
• Locations: 8
• Arm: 1
• Actual Duration (Months): 15.6
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

A study to evaluate safety, tolerability, and pharmacokinetics of a single intravitreal injection of UBX1325 in patients diagnosed with diabetic macular edema (DME) or neovascular Age-Related Macular Degeneration.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema; Neovascular Age-related Macular Degeneration	Drug: UBX1325	Phase 1

Detailed Description

This is a Phase 1, open-label, first-in-human (FIH), single-ascending dose (SAD) study consisting of approximately 4 cohorts. The total number of patients will be at least 3 per cohort plus 3 additional patients in the maximum tolerated dose (MTD) cohort in order to address the primary objective. Up to an additional 6 nAMD patients will be enrolled in the highest dose cohort. A single dose of UBX1325 will be administered intravitreally and all patients will be followed for approximately 6 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open-Label, Single Ascending Dose Study to Assess the Safety and Tolerability of a Single Intravitreal Injection of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration
• Actual Study Start Date: Oct 8, 2020
• Actual Primary Completion Date: Jan 25, 2022
• Actual Study Completion Date: Jan 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment with UBX1325 UBX1325, single intravitreal injection, ascending dose	Drug: UBX1325; Investigational drug intravitreal injection

Outcome Measures

Primary Outcome Measures

1. Ocular and systemic safety and tolerability of a single intravitreal injection of UBX1325 evaluated by the incidence of dose limiting toxicities (DLTs) and treatment emergent adverse events (TEAEs) [24 weeks]

Secondary Outcome Measures

1. Plasma concentration of UBX1325 following a single intravitreal injection [up to 24 hours post dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• nAMD patients who, in the opinion of the Investigator, are inadequately responding to or failed current treatment options.

• Active choroidal neovascularization (CNV) associated with age-related macular degeneration as evidenced on FA and SD-OCT at Day 1, including presence of intraretinal or subretinal fluid.

• BCVA in the study eye (most affected) of 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or worse at screening and on Day 1.

• 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:

• Any ocular/intraocular/periocular infection or inflammation in either eye in the past 4 weeks prior to screening.

• Subretinal hemorrhage with bleeding area ≥4 disc area in the study eye

• Concomitant therapy with anti-VEGF therapies (e.g., Avastin®, Lucentis®, or Eylea®) or previous use of these agents in the study eye within approximately 28 days of study enrollment

• Any retinovascular disease or retinal degeneration other than nAMD in the study eye.

• History of systemic and intraocular steroid use for 6 months prior to Day 1. The use of intravitreal nonbiodegradable steroid implants (ex. Iluvien®, Yutiq®, Retisert®) is prohibited.

• Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging.

• Any uncontrolled medical condition that, in the opinion of the investigator, would preclude participation in this study.

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	MedEye Associates	Miami	Florida	United States	33143
4	Sarasota Retina Institute	Sarasota	Florida	United States	34239
5	Center for Retina and Macular Disease	Winter Haven	Florida	United States	33880
6	MidWest Eye Institute	Indianapolis	Indiana	United States	46290
7	Houston Eye Associates	Houston	Texas	United States	77025
8	Medical Center Ophthalmology Associates	San Antonio	Texas	United States	78240

Sponsors and Collaborators

• Unity Biotechnology, Inc.

Investigators

• Study Chair: Jamie Dananberg, MD, UNITY Biotechnology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Unity Biotechnology, Inc.
• ClinicalTrials.gov Identifier: NCT04537884
• Other Study ID Numbers: UBX1325-01
• First Posted: Sep 3, 2020
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Unity Biotechnology, Inc.: Retinal disease; Macular edema; Diabetes mellitus; Diabetic macular edema; Neovascular Age-Related Macular Degeneration
• Additional relevant MeSH terms: Macular Degeneration; Macular Edema; Wet Macular Degeneration; Edema

Study Results

No Results Posted as of Mar 10, 2022