NCT06630169

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

October 4, 2024

Last Update Submit

January 27, 2025

Conditions

Corneal Edema

Outcome Measures

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)

    Month 6

Study Arms (3)

Arm 1

OTHER

Endothelial polishing zone 1 (low)

Combination Product: Cryopreserved AURN001

Arm 2

OTHER

Endothelial polishing zone 2 (medium)

Combination Product: Cryopreserved AURN001

Arm 3

OTHER

Endothelial polishing zone 3 (high)

Combination Product: Cryopreserved AURN001

Interventions

Cryopreserved AURN001COMBINATION_PRODUCT

Corneal Endothelial Cells and Y27632

Arm 1Arm 2Arm 3

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aurion Biotech site

San Salvador, El Salvador

Location

MeSH Terms

Conditions

Corneal Edema

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Study Manager, OD

    Aurion Biotech

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 8, 2024

Study Start

September 16, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations

EL(1)