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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04537884
• Other study ID #: UBX1325-01
• Status: Completed
• Phase: Phase 1
• Start date: October 8, 2020
• Est. completion date: January 25, 2022

Study information

• Verified date: March 2022
• Source: Unity Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 25, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• UBX1325
Investigational drug intravitreal injection

Locations

Country	Name	City	State
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Houston Eye Associates	Houston	Texas
United States	Salehi Retina Institute	Huntington Beach	California
United States	MidWest Eye Institute	Indianapolis	Indiana
United States	MedEye Associates	Miami	Florida
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Sarasota Retina Institute	Sarasota	Florida
United States	Center for Retina and Macular Disease	Winter Haven	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	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	Plasma concentration of UBX1325 following a single intravitreal injection		up to 24 hours post dose