Corneal EdemaPhase 3NCT07368959
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
A Phase 3 study testing Combination Product: AURN001 + Y-27632 in people with Corneal Edema and Corneal Endothelial Dysfunction, run by Aurion Biotech at 12 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Edema, Corneal Endothelial Dysfunction, Fuchs Endothelial Corneal Dysfunction
- What is being tested?
- Combination Product: AURN001 + Y-27632
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 12 sitesUnited States
- Study dates
- 19 Feb 2026to Jan 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Key Ocular Inclusion Criteria:
(All ocular criteria apply to the study eye unless noted otherwise)
- Have corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
- BCVA between 65 ETDRS letters (approximate 20/50 Snellen equivalent) and 5 ETDRS letters (approximate 20/800 Snellen equivalent)
- Be pseudophakic with PCIOL
Key Ocular Exclusion Criteria:
(All ocular criteria apply to the study eye unless noted otherwise)
- Have progressive corneal dystrophies or degenerations
- Have visually significant corneal or other ocular pathologies
Other inclusion/exclusion criteria may apply.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Investigational Site 7
Atlanta, Georgia, 30339
Investigational Site 3
Cynwyd, Pennsylvania, 19004
Investigational Site 9
Fort Collins, Colorado, 80528
Investigational Site 4
Kansas City, Missouri, 64154
Investigational Site 12
Ladson, South Carolina, 29456
Investigational Site 11
Leland, North Carolina, 28451
Investigational Site 6
Little Rock, Arkansas, 72205
Investigational Site 2
Mesa, Arizona, 85206
Investigational Site 10
Plymouth Meeting, Pennsylvania, 19462
Investigational Site 8
San Antonio, Texas, 78209
Investigational Site 1
Spring, Texas, 77388
Investigational Site 5
Winston-Salem, North Carolina, 27157
About this study
Official title: ASTRA: A Phase 3 Multi-center, Randomized, Double-Masked, Prospective Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-3)
The purpose of this study is to assess the efficacy and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction.
- Conditions
- Corneal Edema, Corneal Endothelial Dysfunction, Fuchs Endothelial Corneal Dysfunction, Pseudophakic Bullous Keratopathy (PBK)
- Being tested
- Combination Product: AURN001 + Y-27632, Placebo
- Keywords
- Best Corrected Visual Acuity, Central corneal thickness, Human Corneal Endothelial Cells, Neltependocel, Postsurgical endothelial dysfunction, Keratoplasty, Pseudophakic Corneal Edema (PCE), Corneal Endothelial Cells, Endothelial Cells, AURN001, Y-27632, Endothelial Keratoplasty, Corneal Endothelial Cell Therapy
- Medical subject headings
- Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination Product: AURN001 + Y-27632Drug
AURN001 will be injected to the anterior chamber of the eye.
PlaceboOther
Placebo control will be injected to the anterior chamber of the eye.
| Study group | Role | What they receive |
|---|---|---|
| AURN001 | Experimental | Participants will receive single dose of AURN001 Receives: Drug: Combination Product: AURN001 + Y-27632 |
| Placebo | Placebo comparator | Participants will receive single dose of placebo control. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who achieve a ≥ 15-letter improvement (3-line gain) from baseline in Best Corrected Visual Acuity (BCVA) at Month 6
Measured: At Month 6
Secondary outcomes (2)
Change from baseline in non-contact Central Corneal Thickness (CCT) at Month 6
Measured: Baseline (Day 1) and At Month 6
Change from baseline in BCVA at Month 6
Measured: Baseline (Day 1) and At Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start19 Feb 2026
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurion Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368959
- Sponsor's protocol ID
- ABA-3
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASTRA: A Phase 3 Multi-center, Randomized, Double-Masked, Prospective Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-3)
- ClinicalTrials.gov ID
- NCT07368959
- Acronym / sponsor ID
- ABA-3
- Conditions
- Corneal Edema, Corneal Endothelial Dysfunction, Fuchs Endothelial Corneal Dysfunction, Pseudophakic Bullous Keratopathy (PBK)
- Keywords
- Best Corrected Visual Acuity, Central corneal thickness, Human Corneal Endothelial Cells, Neltependocel, Postsurgical endothelial dysfunction, Keratoplasty, Pseudophakic Corneal Edema (PCE), Corneal Endothelial Cells
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Aurion BiotechIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 27 Jan 2026 (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 efficacy and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AURN001 | Experimental | Drug: Combination Product: AURN001 + Y-27632Participants will receive single dose of AURN001 |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive single dose of placebo control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Combination Product: AURN001 + Y-27632AURN001 will be injected to the anterior chamber of the eye. | Drug | AURN001 |
| PlaceboPlacebo control will be injected to the anterior chamber of the eye. | Other | Placebo |
Primary outcome
Percentage of participants who achieve a ≥ 15-letter improvement (3-line gain) from baseline in Best Corrected Visual Acuity (BCVA) at Month 6
Time frame: At Month 6
2 secondary outcomes
Change from baseline in non-contact Central Corneal Thickness (CCT) at Month 6
Time frame: Baseline (Day 1) and At Month 6
Change from baseline in BCVA at Month 6
Time frame: Baseline (Day 1) and At Month 6
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 24 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combination Product: AURN001 + Y-27632 in people with Corneal Edema and Corneal Endothelial Dysfunction, run by Aurion Biotech at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage of participants who achieve a ≥ 15-letter improvement (3-line gain) from baseline in Best Corrected Visual Acuity (BCVA) at Month 6 (time frame: At 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 24 Sep 2026.