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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AURN001 High | Experimental | Neltependocel High and Rho-associated protein kinase |
|
| AURN001 Medium | Experimental | Neltependocel Medium and Rho-associated protein kinase |
|
| AURN001 Low | Experimental | Neltependocel Low and Rho-associated protein kinase |
|
| Neltependocel | Experimental | Neltependocel - High |
|
| ROCK | Experimental | Rho-associated protein kinase (ROCK) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AURN001 | Combination Product | Corneal Endothelial Cells and Y27632 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Manager, OD | Aurion Biotech | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurion Biotech site | Little Rock | Arkansas | 72205 | United States | ||
| Aurion Biotech site |
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A total of 97 participants were enrolled and received the study treatment.
This was a multicenter, randomized, double-masked, parallel-arm, dose-ranging Phase 1/2 study evaluating safety, efficacy, and tolerability of AURN001 in participants with corneal edema due to endothelial dysfunction. Three dose levels were compared with neltependocel and Y-27632 alone to assess each component's contribution on efficacy and safety of AURN001.
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| ID | Title | Description |
|---|---|---|
| FG000 | Y-27632 100 µM | Participants received a single intracameral injection of Y-27632 (100 Micromolar [μM]) under local anesthesia. |
| FG001 | Neltependocel 1.0 × 10^6 | Participants received a single intracameral injection of neltependocel 1.0 × 10^6 cells under local anesthesia. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 23, 2024 | Nov 19, 2025 |
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| Corneal Endothelial Cells | Biological | Corneal Endothelial Cells |
|
| Y27632 | Drug | Y27632 |
|
| 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. | 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. | 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. | 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. | 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. | At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12 |
| Los Angeles |
| California |
| 90067 |
| United States |
| Aurion Biotech site | San Francisco | California | 94158 | United States |
| Aurion Biotech site | Atlanta | Georgia | 30339 | United States |
| Aurion Biotech site | Indianapolis | Indiana | 46260 | United States |
| Aurion Biotech site | Wichita | Kansas | 67206 | United States |
| Aurion Biotech site | Minnetonka | Minnesota | 55305 | United States |
| Aurion Biotech site | Garden City | New York | 11576 | United States |
| Aurion Biotech site | Winston-Salem | North Carolina | 27157 | United States |
| Aurion Biotech site | Cincinnati | Ohio | 45242 | United States |
| Aurion Biotech site | Oklahoma City | Oklahoma | 73104 | United States |
| Aurion Biotech site | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Aurion Biotech site | Sioux Falls | South Dakota | 57108 | United States |
| Aurion Biotech site | Houston | Texas | 77027 | United States |
| Aurion Biotech site | Houston | Texas | 77055 | United States |
| Aurion Biotech site | Norfolk | Virginia | 23502 | United States |
| Aurion Biotech site | Seattle | Washington | 98125 | United States |
| Aurion Biotech site | Vancouver | British Columbia | V5Z 1K1 CAN | Canada |
| Aurion Biotech site | Oakville | Ontario | L6H 0J8 CAN | Canada |
| Aurion Biotech site | Toronto | Ontario | M5T 3A9 CAN | Canada |
| FG002 | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 2.5 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| FG003 | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 5.0 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| FG004 | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 1.0 × 10^6 cells administered with Y-27632 100 μM under local anesthesia. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Full Analysis Set comprised of all randomized participants who received any amount of study drug during intracameral injection.
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| ID | Title | Description |
|---|---|---|
| BG000 | Y-27632 100 µM | Participants received a single intracameral injection of Y-27632 (100 Micromolar [μM]) under local anesthesia. |
| BG001 | Neltependocel 1.0 × 10^6 | Participants received a single intracameral injection of neltependocel 1.0 × 10^6 cells under local anesthesia. |
| BG002 | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 2.5 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| BG003 | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 5.0 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| BG004 | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 1.0 × 10^6 cells administered with Y-27632 100 μM under local anesthesia. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set. | Posted | Number | Percentage of participants | Month 6 |
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| Secondary | 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | change in ETDRS letters | Baseline (Day 1) and at Month 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | Microns | Baseline (Day 1) and at Month 6 |
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| Secondary | 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. | Full Analysis Set. Only those participants with data available at specified time points has been presented. | Posted | Number | percentage of participants | At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set. Only those participants with data available at specified time points has been presented. | Posted | Mean | Standard Deviation | change in ETDRS letters | Baseline (Day 1) and at Week 4, Months 2, 3, 4.5, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set. Only those participants with data available at specified time points has been presented. | Posted | Mean | Standard Deviation | Microns | Baseline (Day 1) and at Weeks 1 and 4, Months 2, 3, 4.5, 6, 9, and 12 |
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| Secondary | 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. | Full Analysis Set. Only those participants with data available at specified time points has been presented. | Posted | Number | percentage of participants | At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12 |
|
From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Y-27632 100 µM | Participants received a single intracameral injection of Y-27632 (100 Micromolar [μM]) under local anesthesia. | 0 | 21 | 1 | 21 | 9 | 21 |
| EG001 | Neltependocel 1.0 × 10^6 | Participants received a single intracameral injection of neltependocel 1.0 × 10^6 cells under local anesthesia. | 0 | 18 | 1 | 18 | 11 | 18 |
| EG002 | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 2.5 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. | 0 | 19 | 0 | 19 | 10 | 19 |
| EG003 | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 5.0 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. | 0 | 19 | 0 | 19 | 18 | 19 |
| EG004 | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 1.0 × 10^6 cells administered with Y-27632 100 μM under local anesthesia. | 0 | 20 | 0 | 20 | 14 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hypertension | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Corneal epithelium defect | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Detached Descemet's membrane | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Iridocele | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Iris adhesions | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Posterior capsule opacification | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA (26.1) | Non-systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA (26.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Corneal degeneration | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Epiretinal membrane | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Corneal oedema | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Endocrine ophthalmopathy | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
| |
| Abdominal hernia repair | Surgical and medical procedures | MedDRA (26.1) | Non-systematic Assessment |
| |
| Rotator cuff repair | Surgical and medical procedures | MedDRA (26.1) | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Non-systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (26.1) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study director | Aurion Biotech, Inc. | +1-857-639-4143 | clinicalaffairs@aurionbiotech.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2024 | Nov 19, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015715 | Corneal Edema |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C108830 | Y 27632 |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Difference in response rates |
| -3.8 |
| 2-Sided |
| 95 |
| -28.1 |
| 20.6 |
| Other |
| Fisher Exact | 0.1482 | Difference in response rates | 22.6 | 2-Sided | 95 | -5.5 | 50.6 | Other |
| Fisher Exact | 0.0203 | Difference in response rates | 35.7 | 2-Sided | 95 | 5.9 | 61.6 | Other |
| Fisher Exact | 0.0293 | Difference in response rates | -33.9 | 2-Sided | 95 | -60.3 | -4.6 | Other |
| Fisher Exact | 0.7431 | Difference in response rates | -7.6 | 2-Sided | 95 | -38.9 | 25.3 | Other |
| Fisher Exact | 0.7568 | Difference in response rates | 5.6 | 2-Sided | 95 | -26.8 | 37.3 | Other |
| OG002 | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 2.5 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| OG003 | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 5.0 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| OG004 | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 1.0 × 10^6 cells administered with Y-27632 100 μM under local anesthesia. |
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| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) |
Participants received a single intracameral injection of neltependocel 5.0 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| OG004 | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 1.0 × 10^6 cells administered with Y-27632 100 μM under local anesthesia. |
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| OG002 | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 2.5 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| OG003 | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 5.0 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| OG004 | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 1.0 × 10^6 cells administered with Y-27632 100 μM under local anesthesia. |
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| OG002 | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 2.5 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| OG003 | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 5.0 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| OG004 | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 1.0 × 10^6 cells administered with Y-27632 100 μM under local anesthesia. |
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| OG003 | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 5.0 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| OG004 | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 1.0 × 10^6 cells administered with Y-27632 100 μM under local anesthesia. |
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| OG002 | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 2.5 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| OG003 | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 5.0 × 10^5 cells administered with Y-27632 100 μM under local anesthesia. |
| OG004 | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 1.0 × 10^6 cells administered with Y-27632 100 μM under local anesthesia. |
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