Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04537884 |
Recruitment Status :
Completed
First Posted : September 3, 2020
Last Update Posted : March 10, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Macular Edema Neovascular Age-related Macular Degeneration | Drug: UBX1325 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Open-Label, Single Ascending Dose Study to Assess the Safety and Tolerability of a Single Intravitreal Injection of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration |
Actual Study Start Date : | October 8, 2020 |
Actual Primary Completion Date : | January 25, 2022 |
Actual Study Completion Date : | January 25, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment with UBX1325
UBX1325, single intravitreal injection, ascending dose
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Drug: UBX1325
Investigational drug intravitreal injection |
- 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) [ Time Frame: 24 weeks ]
- Plasma concentration of UBX1325 following a single intravitreal injection [ Time Frame: up to 24 hours post dose ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537884
United States, California | |
Retina-Vitreous Associates Medical Group | |
Beverly Hills, California, United States, 90211 | |
Salehi Retina Institute | |
Huntington Beach, California, United States, 92647 | |
United States, Florida | |
MedEye Associates | |
Miami, Florida, United States, 33143 | |
Sarasota Retina Institute | |
Sarasota, Florida, United States, 34239 | |
Center for Retina and Macular Disease | |
Winter Haven, Florida, United States, 33880 | |
United States, Indiana | |
MidWest Eye Institute | |
Indianapolis, Indiana, United States, 46290 | |
United States, Texas | |
Houston Eye Associates | |
Houston, Texas, United States, 77025 | |
Medical Center Ophthalmology Associates | |
San Antonio, Texas, United States, 78240 |
Study Chair: | Jamie Dananberg, MD | UNITY Biotechnology |
Responsible Party: | Unity Biotechnology, Inc. |
ClinicalTrials.gov Identifier: | NCT04537884 |
Other Study ID Numbers: |
UBX1325-01 |
First Posted: | September 3, 2020 Key Record Dates |
Last Update Posted: | March 10, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Retinal disease Macular edema Diabetes mellitus Diabetic macular edema Neovascular Age-Related Macular Degeneration |
Macular Degeneration Macular Edema Wet Macular Degeneration Edema |
Retinal Degeneration Retinal Diseases Eye Diseases |