Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Conditions
Keywords
Retinal disease, Macular edema, Diabetes mellitus, Diabetic macular edema, Neovascular Age-Related Macular Degeneration
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.
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.
Interventions
DRUGUBX1325
Investigational drug intravitreal injection
Sponsors
Unity Biotechnology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Plasma concentration of UBX1325 following a single intravitreal injection | up to 24 hours post dose |
Countries
United States
Outcome results
None listed