Status:
COMPLETED
Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)
Lead Sponsor:
Unity Biotechnology, Inc.
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.
Detailed Description
This is a Phase 2 study. During Screening, every patient will receive a run-in injection of aflibercept. On Day 1, patients will be randomized to either the UBX1325 arm or the aflibercept arm. Patient...
Eligibility Criteria
Inclusion
- Patients aged ≥50 years.
- Active CNV associated with age-related macular degeneration as evidenced on FA and SD-OCT with presence of intraretinal or subretinal fluid at Screening and Day 1
- BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening.
- 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
- Concurrent disease in the study eye or structural damage, other than wet AMD, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or CFP in the study eye.
- Any ocular/intraocular/periocular infection or inflammation in either eye in the past 12 weeks prior to screening
- Subretinal hemorrhage with bleeding area of 4 or greater disc area in the study eye
- History of vitreous hemorrhage in the study eye within 2 months prior to Screening
- Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study
- Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT05275205
Start Date
March 2 2022
End Date
July 25 2023
Last Update
August 7 2024
Active Locations (14)
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1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
2
Salehi Retina Institute
Huntington Beach, California, United States, 92647
3
Advanced Vision Research Institute
Longmont, Colorado, United States, 80503
4
Rand Eye Institute
Deerfield Beach, Florida, United States, 33064