Phase 2
Completed N=51
Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)
Source: ClinicalTrials.gov NCT05275205 ↗Enrolled (actual)
51
Serious AEs
10.0%
Results posted
Aug 2024
Primary outcomePrimary: Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control — 19; 18; 2; 0 Participants
Summary
This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control |
19; 18; 2; 0; 1; 0 | — |
| SECONDARY Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time |
58; 62.4; -0.2; 3.1; 1.7; 3.0 | — |
| SECONDARY Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center |
374.1; 367.5; 29.9; -35.0; 56.6; -14.9 | — |
| SECONDARY Adverse Events (Safety) |
20; 20; 0; 2; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05275205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.