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Active, not recruitingNCT06630169Updated Jan 28, 2025

Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction

A Phase 2 interventional study of Cryopreserved AURN001 in Corneal Edema, sponsored by Aurion Biotech. Active, not recruiting at 1 site in El Salvador. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-01-28.

Sponsored by Aurion Biotech · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as active, not recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

The purpose of this study is to assess the safety and efficacy of cryopreserved AURN001 in patients with corneal edema secondary to endothelial dysfunction.

02

Conditions studied

  • Corneal Edema

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03

In context

Corneal Edema

45 studies on the registry are indexed under Corneal Edema; 7 are open to participants now.

This study's enrollment of 25 is below the median of 42 across 37 interventional studies indexed under Corneal Edema.

Browse Corneal Edema studies →

Lead sponsor

Aurion Biotech is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
  • BCVA no worse than 5 ETDRS letters (i.e., 1.6 LogMAR or approximate 20/800 Snellen equivalent).

Exclusion criteria

Exclusion Criteria:

  • Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye
  • Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Other
    Arm 1

    Endothelial polishing zone 1 (low)

    Combination Product: Cryopreserved AURN001

  • Other
    Arm 2

    Endothelial polishing zone 2 (medium)

    Combination Product: Cryopreserved AURN001

  • Other
    Arm 3

    Endothelial polishing zone 3 (high)

    Combination Product: Cryopreserved AURN001

Interventions

  • Combination productCryopreserved AURN001

    Corneal Endothelial Cells and Y27632

06

What researchers measure

Primary outcomes

  1. BCVA - 15-letter improvement (3-line gain)

    Response, defined as a ≥15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA)

    Time frame: Month 6

07

Study locations

1 site
  • Aurion Biotech site
    San Salvador, El Salvador
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06630169
Lead sponsor
Aurion Biotech
Responsible party
Sponsor
First posted
Oct 8, 2024
Start date
Sep 16, 2024
Primary completion
Oct 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Jan 28, 2025

Study contacts

Study Manager, OD
study director · Aurion Biotech

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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