NCT05202587|CompletedDMC
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Sponsor study identifier
observational
386
1 country
5
Study Start
November 10, 2021
Actual (reported)Primary Completion
January 12, 2023
Actual (reported)Study Completion
January 12, 2023
Actual (reported)This multi-center study will enroll Adult subjects diagnosed with neo-vascular age-related macular degeneration (NV-AMD) in at least one eye at the time of enrollment. the subject study duration for this study is one day (2-3 hours). Each study site will have two NVHO devices and one Cirrus 5000 and the patients will be scand on the two NVHO devices and one Cirrus device as a part of the study flow. At the Study Visit, fluid must be present in approximately 280 study eyes and fluid must be absent from 20 study eyes. Each subject will only have one study eye. The fluid status will be determined by the investigator while reviewing an acceptable screening Cirrus OCT volume scan.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 12, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 10, 2021
Actual (reported)January 9, 2022
Actual (reported)January 21, 2022
Actual (reported)January 12, 2023
Actual (reported)January 12, 2023
Actual (reported)Intra-Retinal Fluid (IRF)
volume \[nl\] of the Intra-retinal fluid
5 minutes
Sub-Retinal Fluid (SRF)
volume \[nl\] of the Sub-retinal fluid
5 minutes
IRF spatial distribution
frontal view (en-face) of IRF thickness map
5 minutes
SRF spatial distribution
frontal view (en-face) of SRF thickness map
5 minutes
IRF area segmentation
Segmented B-scans of the IRF
5 minutes
SRF area segmentation
Segmented B-scans of the ISRF
5 minutes
The study will enroll approximately 140 AMD patients diagnosed with NV-AMD presenting with IRF and 140 AMD patients presenting with SRF in at least one eye at the time of enrollment, and 20 eyes with no fluid for a total of 300 subjects
Brian Joondeph
Lakewood, Colorado, 80228, United States
Florida Retina Institute, PA
Orlando, Florida, 32806, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Tennessee Retina, PC
Nashville, Tennessee, 37203, United States
Strategic Clinical Research Group
Willow Park, Texas, 76087, United States
Gidi Benyamini
Notal vision Druyanov 5, Tel Aviv
386 participants (actual enrollment reported by the registry).
First Submitted
January 9, 2022
First Posted
January 21, 2022
Study Start
November 10, 2021
Actual (reported)Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)
Mean central retinal thickness
Retina thickness (µ) in 5 central ETDRS grid fields (Total, superior, temporal, inferior, nasal, and central)
5 minutes
Contact the study team to confirm eligibility.
Primary Completion
January 12, 2023
Actual (reported)Study Completion
January 12, 2023
Actual (reported)Last Updated
February 15, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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