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

  • days left to enroll
  • participants needed
  • sponsor
    Unity Biotechnology, Inc.
Updated on 27 June 2021


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.


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.

Condition Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Neovascular Age Related Macular Degeneration
Treatment UBX1325
Clinical Study IdentifierNCT04537884
SponsorUnity Biotechnology, Inc.
Last Modified on27 June 2021


Yes No Not Sure

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