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The study was stopped early (n=35) enabling the data to guide design of the subsequent clinical study.
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| Name | Class |
|---|---|
| Amber Ophthalmics, Inc. | INDUSTRY |
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This study will enroll participants with a non-infected, corneal persistent epithelial defect (PED) resulting from an ocular chemical and/or thermal ocular injury which is non-responsive or refractory to current standard of care for at least 14 days. It will assess the efficacy and safety of Nexagon® (lufepirsen) plus standard of care versus NEXAGON-vehicle (placebo) plus standard of care. The recovery of the corneal epithelium will be the primary outcome measure, defined as a cornea that re-epithelializes by Day 28 of treatment and remains re-epithelialized for at least a further 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nexagon® (lufepirsen) High Dose Concentration | Experimental |
| |
| Nexagon® (lufepirsen) Low Dose Concentration | Experimental |
| |
| Vehicle | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexagon® (lufepirsen) High Dose Concentration | Drug | Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Subjects Achieving Corneal Epithelial Recovery, as Assessed by Slit Lamp Examination. | Corneal epithelial recovery, defined as corneal reepithelialization and maintenance of a durable epithelium for at least 28 days, will be assessed by slit lamp examination. | Up to 56 days. |
| Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v 5.0 | Incidence of Treatment Emergent Adverse Events as assessed by CTCAE v 5.0. | Up to 30 days after last application of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Feldman | Amber Ophthalmics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jules Stein Eye Institute | Los Angeles | California | 90095 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nexagon® (Lufepirsen) High Dose Concentration | Nexagon® (lufepirsen) High Dose Concentration: Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days. Open-label Nexagon® (lufepirsen): Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. |
| 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 | Apr 19, 2022 | Jul 16, 2024 |
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| Nexagon® (lufepirsen) Low Dose Concentration | Drug | Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days. |
|
| Vehicle | Drug | Vehicle is administered topically in the affected eye three (3) times over 28 days. |
|
|
| Open-label Nexagon® (lufepirsen) | Drug | Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. |
|
| FG001 |
| Nexagon® (Lufepirsen) Low Dose Concentration |
Nexagon® (lufepirsen) Low Dose Concentration: Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days. Open-label Nexagon® (lufepirsen): Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. |
| FG002 | Vehicle | Vehicle: Vehicle is administered topically in the affected eye three (3) times over 28 days. Open-label Nexagon® (lufepirsen): Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nexagon® (Lufepirsen) High Dose Concentration | Nexagon® (lufepirsen) High Dose Concentration: Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days. Open-label Nexagon® (lufepirsen): Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. |
| BG001 | Nexagon® (Lufepirsen) Low Dose Concentration | Nexagon® (lufepirsen) Low Dose Concentration: Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days. Open-label Nexagon® (lufepirsen): Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. |
| BG002 | Vehicle | Vehicle: Vehicle is administered topically in the affected eye three (3) times over 28 days. Open-label Nexagon® (lufepirsen): Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. |
| BG003 | 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 |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Subjects with of Persistent Epithelial Defect | Count of Participants | Participants |
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| 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 | The Proportion of Subjects Achieving Corneal Epithelial Recovery, as Assessed by Slit Lamp Examination. | Corneal epithelial recovery, defined as corneal reepithelialization and maintenance of a durable epithelium for at least 28 days, will be assessed by slit lamp examination. | Posted | Count of Participants | Participants | Up to 56 days. |
|
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| |||||||||||||||||||||||||||||||||
| Primary | Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v 5.0 | Incidence of Treatment Emergent Adverse Events as assessed by CTCAE v 5.0. | Posted | Count of Participants | Participants | Up to 30 days after last application of intervention |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nexagon® (Lufepirsen) High Dose Concentration | Nexagon® (lufepirsen) High Dose Concentration: Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days. Open-label Nexagon® (lufepirsen): Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. | 0 | 12 | 0 | 12 | 7 | 12 |
| EG001 | Nexagon® (Lufepirsen) Low Dose Concentration | Nexagon® (lufepirsen) Low Dose Concentration: Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days. Open-label Nexagon® (lufepirsen): Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. | 0 | 12 | 1 | 12 | 8 | 12 |
| EG002 | Vehicle | Vehicle: Vehicle is administered topically in the affected eye three (3) times over 28 days. Open-label Nexagon® (lufepirsen): Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. | 0 | 11 | 0 | 11 | 7 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cicatricial ectropion with lateral lagophthalmos and exposed lacrimal gland | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symblepharon | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Corneal epithelium defect | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Eye pain | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Blepharitis | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Cataract | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Conjunctival hyperaemia | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Corneal neovascularisation | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Corneal thinning | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Dry eye | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Ectropion | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Eye irritation | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Eye pruritus | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Lacrimation increased | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Ocular hyperaemia | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Visual impairment | Eye disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Hyperplasia | General disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Seasonal allergy | Immune system disorders | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Hypopyon | Infections and infestations | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Periorbital cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Eyelid scar | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment | Study Eye |
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| Cataract | Eye disorders | MedDRA 23.0 | Systematic Assessment | Fellow Eye |
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| Seasonal allergy | Immune system disorders | MedDRA 23.0 | Systematic Assessment | Fellow Eye |
|
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment | Non-Ocular |
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| Blood bilirubin increased | Investigations | MedDRA 23.0 | Systematic Assessment | Non-Ocular |
|
Early termination leading to small numbers of subjects analyzed
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Amber Ophthalmics | 858-539-3418 | clinical@Amberophthalmics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2022 | Jul 16, 2024 | SAP_001.pdf |
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| 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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| India |
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