Trial · NCT06041256
A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)
NCT06041256, Phase 1, Phase 2, Completed, Aurion Biotech; results first posted 2025-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1). Trials, record NCT06041256. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06041256
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)
- NCT number
- NCT06041256
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 97 participants, actual
- Lead sponsor
- Aurion Biotech
- Conditions
- Corneal Edema, Corneal Endothelial Dysfunction
- Interventions
- AURN001, Corneal Endothelial Cells, Y27632
- First posted
- 2023-09-18
- Last updated
- 2025-12-17
- Results first posted
- 2025-12-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data | 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. |
| Secondary | Change From Baseline in BCVA at Month 6 | Baseline (Day 1) and 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. |
| Secondary | Change From Baseline in Central Corneal Thickness (CCT) at Month 6 | Baseline (Day 1) and 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. |
| Secondary | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12 | 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. |
| Secondary | Change From Baseline in BCVA at All Other Timepoints | Baseline (Day 1) and at Week 4, Months 2, 3, 4.5, 6, 9 and 12 | 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. |
| Secondary | Change From Baseline in CCT at All Other Timepoints | Baseline (Day 1) and at Weeks 1 and 4, Months 2, 3, 4.5, 6, 9, and 12 | 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. |
| Secondary | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12 | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data | Month 6 | Full Analysis Set. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in BCVA at Month 6 | Baseline (Day 1) and at Month 6 | Full Analysis Set. | change in ETDRS letters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Central Corneal Thickness (CCT) at Month 6 | Baseline (Day 1) and at Month 6 | Full Analysis Set. | Microns | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12 | Full Analysis Set. Only those participants with data available at specified time points has been presented. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in BCVA at All Other Timepoints | Baseline (Day 1) and at Week 4, Months 2, 3, 4.5, 6, 9 and 12 | Full Analysis Set. Only those participants with data available at specified time points has been presented. | change in ETDRS letters | MEAN |
| SECONDARY | Change From Baseline in CCT at All Other Timepoints | Baseline (Day 1) and at Weeks 1 and 4, Months 2, 3, 4.5, 6, 9, and 12 | Full Analysis Set. Only those participants with data available at specified time points has been presented. | Microns | MEAN |
| SECONDARY | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12 | Full Analysis Set. Only those participants with data available at specified time points has been presented. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group160
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data | Y-27632 100 µM | 14.3 | Percentage of participants | ||
| Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data | Neltependocel (1.0 × 10^6) | 44.4 | Percentage of participants | ||
| Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | 10.5 | Percentage of participants | ||
| Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | 36.8 | Percentage of participants | ||
| Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | 50.0 | Percentage of participants | ||
| Change From Baseline in BCVA at Month 6 | Y-27632 100 µM | -25.5 | Standard Error 6.06 | change in ETDRS letters | |
| Change From Baseline in BCVA at Month 6 | Neltependocel (1.0 × 10^6) | -5.1 | Standard Error 6.41 | change in ETDRS letters | |
| Change From Baseline in BCVA at Month 6 | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | -15.7 | Standard Error 6.24 | change in ETDRS letters | |
| Change From Baseline in BCVA at Month 6 | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | -3.0 | Standard Error 6.25 | change in ETDRS letters | |
| Change From Baseline in BCVA at Month 6 | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | 10.4 | Standard Error 6.17 | change in ETDRS letters |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Y-27632 100 µM | 21 | |
| Overall Study | STARTED | Neltependocel 1.0 × 10^6 | 18 | |
| Overall Study | STARTED | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | 19 | |
| Overall Study | STARTED | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | 19 | |
| Overall Study | STARTED | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | 20 | |
| Overall Study | COMPLETED | Y-27632 100 µM | 3 | |
| Overall Study | COMPLETED | Neltependocel 1.0 × 10^6 | 12 | |
| Overall Study | COMPLETED | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | 7 | |
| Overall Study | COMPLETED | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | 12 | |
| Overall Study | COMPLETED | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | 17 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events260
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ocular hypertension | Eye disorders | Y-27632 100 µM | 3 | 21 | |
| other | Ocular hypertension | Eye disorders | Neltependocel 1.0 × 10^6 | 2 | 18 | |
| other | Ocular hypertension | Eye disorders | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | 3 | 19 | |
| other | Ocular hypertension | Eye disorders | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | 2 | 19 | |
| other | Ocular hypertension | Eye disorders | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | 1 | 20 | |
| other | Conjunctival haemorrhage | Eye disorders | Y-27632 100 µM | 2 | 21 | |
| other | Conjunctival haemorrhage | Eye disorders | Neltependocel 1.0 × 10^6 | 0 | 18 | |
| other | Conjunctival haemorrhage | Eye disorders | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | 1 | 19 | |
| other | Conjunctival haemorrhage | Eye disorders | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | 1 | 19 | |
| other | Conjunctival haemorrhage | Eye disorders | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | 2 | 20 |
1 to 10 of 260Source ClinicalTrials.gov
See all 260 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Y-27632 100 µM | 0 | 21 |
| Total, all-cause mortality | Neltependocel 1.0 × 10^6 | 0 | 18 |
| Total, all-cause mortality | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | 0 | 19 |
| Total, all-cause mortality | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | 0 | 19 |
| Total, all-cause mortality | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | 0 | 20 |
| Total, other adverse events | Y-27632 100 µM | 9 | 21 |
| Total, other adverse events | Neltependocel 1.0 × 10^6 | 11 | 18 |
| Total, other adverse events | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | 10 | 19 |
| Total, other adverse events | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | 18 | 19 |
| Total, other adverse events | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | 14 | 20 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06041256
GET https://conductscience.org/api/trials/v1/NCT06041256/results?page=2