Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration
- Conditions
- Diabetic Macular EdemaNeovascular Age-related Macular Degeneration
- Interventions
- Registration Number
- NCT04537884
- Lead Sponsor
- Unity Biotechnology, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment with UBX1325 UBX1325 UBX1325, single intravitreal injection, ascending dose
- Primary Outcome Measures
Name Time Method 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
Name Time Method Plasma concentration of UBX1325 following a single intravitreal injection up to 24 hours post dose
Trial Locations
- Locations (8)
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Salehi Retina Institute
🇺🇸Huntington Beach, California, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
MidWest Eye Institute
🇺🇸Indianapolis, Indiana, United States
MedEye Associates
🇺🇸Miami, Florida, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States