Corneal EdemaPhase 2NCT06630169
Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
A Phase 2 study testing Cryopreserved AURN001 in people with Corneal Edema, run by Aurion Biotech at 1 site in El Salvador.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Corneal Edema
- What is being tested?
- Cryopreserved AURN001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEl Salvador
- Study dates
- 16 Sep 2024to Oct 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: APANECA: A Prospective, Parallel-arm, Multi-Surgeon Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (2024-E002-C)
The purpose of this study is to assess the safety and efficacy of cryopreserved AURN001 in patients with corneal edema secondary to endothelial dysfunction.
- Conditions
- Corneal Edema
- Being tested
- Cryopreserved AURN001
- Medical subject headings
- Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryopreserved AURN001Combination product
Corneal Endothelial Cells and Y27632
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Endothelial polishing zone 1 (low) Receives: Combination Product: Cryopreserved AURN001 |
| Arm 2 | Other | Endothelial polishing zone 2 (medium) Receives: Combination Product: Cryopreserved AURN001 |
| Arm 3 | Other | Endothelial polishing zone 3 (high) Receives: Combination Product: Cryopreserved AURN001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start16 Sep 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurion Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Manager, OD, Study director, Aurion Biotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630169
- Sponsor's protocol ID
- APANECA
- Status last verified
- Jan 2025
- First submitted
- 4 Oct 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APANECA: A Prospective, Parallel-arm, Multi-Surgeon Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (2024-E002-C)
- ClinicalTrials.gov ID
- NCT06630169
- Acronym / sponsor ID
- APANECA
- Conditions
- Corneal Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Aurion BiotechIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of cryopreserved AURN001 in patients with corneal edema secondary to endothelial dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Combination Product: Cryopreserved AURN001Endothelial polishing zone 1 (low) |
| Arm 2 | Other | Combination Product: Cryopreserved AURN001Endothelial polishing zone 2 (medium) |
| Arm 3 | Other | Combination Product: Cryopreserved AURN001Endothelial polishing zone 3 (high) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryopreserved AURN001Corneal Endothelial Cells and Y27632 | Combination product | Arm 1, Arm 2, Arm 3 |
Primary outcome
BCVA - 15-letter improvement (3-line gain)
Time frame: Month 6
Response, defined as a ≥15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
Related trials for Corneal Edema
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
Active, not recruitingPhase 3
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Corneal Endothelial Dysfunction
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
Recruiting
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
Fuchs' Endothelial Dystrophy, Corneal Edema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Manager, OD study director
Aurion Biotech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cryopreserved AURN001 in people with Corneal Edema, run by Aurion Biotech at 1 site in El Salvador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA - 15-letter improvement (3-line gain) (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.