Diabetic Macular Edema Clinical Trial
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
Verified date | March 2022 |
Source | Unity Biotechnology, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | January 25, 2022 |
Est. primary completion date | January 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Retina-Vitreous Associates Medical Group | Beverly Hills | California |
United States | Houston Eye Associates | Houston | Texas |
United States | Salehi Retina Institute | Huntington Beach | California |
United States | MidWest Eye Institute | Indianapolis | Indiana |
United States | MedEye Associates | Miami | Florida |
United States | Medical Center Ophthalmology Associates | San Antonio | Texas |
United States | Sarasota Retina Institute | Sarasota | Florida |
United States | Center for Retina and Macular Disease | Winter Haven | Florida |
Lead Sponsor | Collaborator |
---|---|
Unity Biotechnology, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Plasma concentration of UBX1325 following a single intravitreal injection | up to 24 hours post dose |
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