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

Unity Biotechnology

Status and phase

Completed

Phase 1

Conditions

Diabetic Macular Edema

Neovascular Age-related Macular Degeneration

Treatments

Drug: UBX1325

Study type

Interventional

Funder types

Industry

Identifiers

NCT04537884

UBX1325-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.