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

NCT ID: NCT06630169

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2025-10-31

Brief Summary

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

Detailed Description

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Conditions

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Corneal Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Endothelial polishing zone 1 (low)

Group Type OTHER

Cryopreserved AURN001

Intervention Type COMBINATION_PRODUCT

Corneal Endothelial Cells and Y27632

Arm 2

Endothelial polishing zone 2 (medium)

Group Type OTHER

Cryopreserved AURN001

Intervention Type COMBINATION_PRODUCT

Corneal Endothelial Cells and Y27632

Arm 3

Endothelial polishing zone 3 (high)

Group Type OTHER

Cryopreserved AURN001

Intervention Type COMBINATION_PRODUCT

Corneal Endothelial Cells and Y27632

Interventions

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Cryopreserved AURN001

Corneal Endothelial Cells and Y27632

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aurion Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Manager, OD

Role: STUDY_DIRECTOR

Aurion Biotech

Locations

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Aurion Biotech site

San Salvador, , El Salvador

Site Status

Countries

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El Salvador

Other Identifiers

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APANECA

Identifier Type: -

Identifier Source: org_study_id

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