Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)

Completed · Phase 2 · Has a placebo group

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.

Key facts

Study ID

NCT05275205

Run by

Unity Biotechnology, Inc.

People needed

51

Starts

2022-03-02

Expected to finish

2023-07-25

Last updated by the study team

2024-08-07

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• Salehi Retina Institute — Huntington Beach, California, United States
• Advanced Vision Research Institute — Longmont, Colorado, United States
• Rand Eye Institute — Deerfield Beach, Florida, United States
• Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States
• University Retina and Macula Associates — Lemont, Illinois, United States
• Illinois Eye Center — Peoria, Illinois, United States
• Midwest Eye — Carmel, Indiana, United States
• Mayo Clinic-Rochester — Rochester, Minnesota, United States
• Sierra Eye Associates — Reno, Nevada, United States
• EyeHealth Northwest — Portland, Oregon, United States
• Retina Research Institution of Texas — Abilene, Texas, United States
• Valley Retina Institute — McAllen, Texas, United States
• Austin Retina Associates — Round Rock, Texas, United States

Full record on ClinicalTrials.gov

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