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

Completed · Phase 1

Conditions studied: Diabetic Macular Edema, Neovascular Age-related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT04537884

Run by

Unity Biotechnology, Inc.

People needed

19

Starts

2020-10-08

Expected to finish

2022-01-25

Last updated by the study team

2022-03-10

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• Salehi Retina Institute — Huntington Beach, California, United States
• MedEye Associates — Miami, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• MidWest Eye Institute — Indianapolis, Indiana, United States
• Houston Eye Associates — Houston, Texas, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.