Corneal EdemaPhase 1/2CLARANCT06041256

A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)

A Phase 1/2 study testing AURN001, Corneal Endothelial Cells and Y27632 in people with Corneal Edema and Corneal Endothelial Dysfunction, run by Aurion Biotech at 20 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Corneal Edema, Corneal Endothelial Dysfunction
What is being tested?: AURN001, Corneal Endothelial Cells and Y27632
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 97 participants
Where: 20 sitesin 2 countries
Study dates: 18 Oct 2023to 15 Apr 2025
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 between 65 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (i.e., 0.4 LogMAR or approximate 20/50 Snellen equivalent) and 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

20 sites in 2 countries.

Country

City, postcode or hospital

20 sites in 2 countries

United States17 sites

Aurion Biotech site
Atlanta, Georgia, 30339
Aurion Biotech site
Bala-Cynwyd, Pennsylvania, 19004
Aurion Biotech site
Cincinnati, Ohio, 45242
Aurion Biotech site
Garden City, New York, 11576
Aurion Biotech site
Houston, Texas, 77027
Aurion Biotech site
Houston, Texas, 77055
Aurion Biotech site
Indianapolis, Indiana, 46260
Aurion Biotech site
Little Rock, Arkansas, 72205
Aurion Biotech site
Los Angeles, California, 90067
Aurion Biotech site
Minnetonka, Minnesota, 55305
Aurion Biotech site
Norfolk, Virginia, 23502
Aurion Biotech site
Oklahoma City, Oklahoma, 73104
Aurion Biotech site
San Francisco, California, 94158
Aurion Biotech site
Seattle, Washington, 98125
Aurion Biotech site
Sioux Falls, South Dakota, 57108
Aurion Biotech site
Wichita, Kansas, 67206
Aurion Biotech site
Winston-Salem, North Carolina, 27157

Other trials in United States

Canada3 sites

Aurion Biotech site
Oakville, Ontario, L6H 0J8 CAN
Aurion Biotech site
Toronto, Ontario, M5T 3A9 CAN
Aurion Biotech site
Vancouver, British Columbia, V5Z 1K1 CAN

Other trials in Canada

About this study

Official title: CLARA: A Phase 1/2 Multi-center, Randomized, Double-Masked, Prospective, Parallel-Arm Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)

The goal of this clinical trial is to compare different doses of AURN001 in patients with corneal edema secondary to corneal endothelial dysfunction. The main questions the clinical trial aims to answer are whether AURN001 effective and safe. Participants will receive a single injection of AURN001. A comparison between low, medium, and high doses of AURN001 against the contribution of each element, cells alone and Y27632 alone, will be conducted to determine the effects on corneal edema.

Conditions: Corneal Edema, Corneal Endothelial Dysfunction
Being tested: AURN001, Corneal Endothelial Cells, Y27632
Medical subject headings: Corneal Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AURN001Combination product
Corneal Endothelial Cells and Y27632
Corneal Endothelial CellsBiological
Corneal Endothelial Cells
Y27632Drug
Y27632

Study groups in NCT06041256
Study group	Role	What they receive
AURN001 High	Experimental	Neltependocel High and Rho-associated protein kinase Receives: Combination Product: AURN001
AURN001 Medium	Experimental	Neltependocel Medium and Rho-associated protein kinase Receives: Combination Product: AURN001
AURN001 Low	Experimental	Neltependocel Low and Rho-associated protein kinase Receives: Combination Product: AURN001
Neltependocel	Experimental	Neltependocel - High Receives: Biological: Corneal Endothelial Cells
ROCK	Experimental	Rho-associated protein kinase (ROCK) Receives: Drug: Y27632

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data
Best-corrected visual acuity was assessed using Early Treatment Diabetic Retinopathy Study(ETDRS) method, standard for vision testing. Standardized Sloan letter charts with 5 letters per line, decreasing by 0.1 logarithm of minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Data presented represent number of participants with available BCVA measurements at Month 6, with those who had missing data, underwent rescue surgery before Month 6, or discontinued study prior to Month 6 imputed as non-responders.
Measured: Month 6

Secondary outcomes (6)

Change From Baseline in BCVA at Month 6
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Measured: Baseline (Day 1) and at Month 6
Change From Baseline in Central Corneal Thickness (CCT) at Month 6
Central corneal thickness was measured by pachymetry which is an essential anatomical marker for detecting the presence or absence of edema and serves as a supportive indicator of treatment efficacy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Measured: Baseline (Day 1) and at Month 6
Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. The data presented reflect only participants with non-missing BCVA at each corresponding visit.
Measured: At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12
Change From Baseline in BCVA at All Other Timepoints
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Measured: Baseline (Day 1) and at Week 4, Months 2, 3, 4.5, 6, 9 and 12
Change From Baseline in CCT at All Other Timepoints
Central corneal thickness was measured by pachymetry which is an essential anatomical marker for detecting the presence or absence of edema and serves as a supportive indicator of treatment efficacy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Measured: Baseline (Day 1) and at Weeks 1 and 4, Months 2, 3, 4.5, 6, 9, and 12
Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. The data presented reflect only participants with non-missing BCVA at each corresponding visit.
Measured: At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 202315 Apr 2025

First posted18 Sep 2023
Study start18 Oct 2023
Primary completion25 Oct 2024
Study completion15 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06041256
Sponsor's protocol ID: ABA-1
Acronym: CLARA
Status last verified: Dec 2025
First submitted: 11 Sep 2023
Last updated: 17 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Corneal Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CLARA: A Phase 1/2 Multi-center, Randomized, Double-Masked, Prospective, Parallel-Arm Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)
ClinicalTrials.gov ID: NCT06041256
Acronym / sponsor ID: CLARA / ABA-1
Conditions: Corneal Edema, Corneal Endothelial Dysfunction
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: Aurion BiotechIndustry (pharma, biotech, devices)
Study start: 18 Oct 2023 (actual)
Primary completion: 25 Oct 2024 (actual)
Study completion: 15 Apr 2025 (actual)
First posted: 18 Sep 2023 (actual)
Results: Posted 17 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
AURN001 High	Experimental	Combination Product: AURN001Neltependocel High and Rho-associated protein kinase
AURN001 Medium	Experimental	Combination Product: AURN001Neltependocel Medium and Rho-associated protein kinase
AURN001 Low	Experimental	Combination Product: AURN001Neltependocel Low and Rho-associated protein kinase
Neltependocel	Experimental	Biological: Corneal Endothelial CellsNeltependocel - High
ROCK	Experimental	Drug: Y27632Rho-associated protein kinase (ROCK)

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 between 65 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (i.e., 0.4 LogMAR or approximate 20/50 Snellen equivalent) and 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
AURN001Corneal Endothelial Cells and Y27632	Combination product	AURN001 High, AURN001 Low, AURN001 Medium
Corneal Endothelial CellsCorneal Endothelial Cells	Biological	Neltependocel
Y27632Y27632	Drug	ROCK

Primary outcome

Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data
Time frame: Month 6
Best-corrected visual acuity was assessed using Early Treatment Diabetic Retinopathy Study(ETDRS) method, standard for vision testing. Standardized Sloan letter charts with 5 letters per line, decreasing by 0.1 logarithm of minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Data presented represent number of participants with available BCVA measurements at Month 6, with those who had missing data, underwent rescue surgery before Month 6, or discontinued study prior to Month 6 imputed as non-responders.

6 secondary outcomes

Change From Baseline in BCVA at Month 6
Time frame: Baseline (Day 1) and at Month 6
Change From Baseline in Central Corneal Thickness (CCT) at Month 6
Time frame: Baseline (Day 1) and at Month 6
Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data
Time frame: At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12
Change From Baseline in BCVA at All Other Timepoints
Time frame: Baseline (Day 1) and at Week 4, Months 2, 3, 4.5, 6, 9 and 12
Change From Baseline in CCT at All Other Timepoints
Time frame: Baseline (Day 1) and at Weeks 1 and 4, Months 2, 3, 4.5, 6, 9, and 12
Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data
Time frame: At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12

Results and safety

Results posted to the registry on 17 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Y-27632 100 µM	21	3
Neltependocel 1.0 × 10^6	18	12
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)	19	7
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)	19	12
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)	20	17

Primary outcome: Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data

Time frame: Month 6. Number. Unit: Percentage of participants

Measure	Y-27632 100 µM n = 21	Neltependocel (1.0 × 10^6) n = 18	AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) n = 19	AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) n = 19	AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) n = 20
Value	14.3	44.4	10.5	36.8	50.0

Y-27632 100 µM vs Neltependocel (1.0 × 10^6): Difference in response rates: 30.2 (95% CI 0.8 to 58.3), p = 0.0722, Fisher Exact
Y-27632 100 µM vs AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM): Difference in response rates: -3.8 (95% CI -28.1 to 20.6), p >0.9999, Fisher Exact
Y-27632 100 µM vs AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM): Difference in response rates: 22.6 (95% CI -5.5 to 50.6), p = 0.1482, Fisher Exact

Population analysed: Full Analysis Set.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose (Day 1) through Month 12. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Y-27632 100 µM	1 of 21 (4.8%)	9 of 21 (42.9%)	0 of 21
Neltependocel 1.0 × 10^6	1 of 18 (5.6%)	11 of 18 (61.1%)	0 of 18
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)	0 of 19 (0%)	10 of 19 (52.6%)	0 of 19
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)	0 of 19 (0%)	18 of 19 (94.7%)	0 of 19
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)	0 of 20 (0%)	14 of 20 (70%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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

20 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AURN001, Corneal Endothelial Cells and Y27632 in people with Corneal Edema and Corneal Endothelial Dysfunction, run by Aurion Biotech at 20 sites in 2 countries.

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: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06041256.

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 17 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.