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This study terminated due to slow enrollment
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The study design is a prospective, randomized, controlled interventional study to compare the outcome of ProKera Plus® with conventional treatment in patients with vision-threatening bacterial corneal ulcers. The study will be conducted at the University of Arkansas Medical Sciences (UAMS) in two phases for patients who present to an Ophthalmology clinic or Emergency Department at UAMS.
Bacterial keratitis is a serious bacterial infection of the cornea, usually caused by a persistent epithelial defect or ulcer that can lead to permanent vision loss from corneal scarring, perforation or endophthalmitis. An infectious corneal ulcer requires immediate treatment with intensive topical fortified broad-spectrum antibiotics to try to eliminate the pathogen. Corneal tissue destruction can be caused directly by infectious agents, the associated inflammatory response, or by ocular toxicity from frequent dosing of fortified antibiotics.1 Sutured amniotic membrane transplantation (AMT) has been shown to reduce pain and promote healing in human bacterial keratitis.2 ProKera® is a sutureless form of CryoTek amniotic membrane that is clipped into a dual polycarbonate ring system with the epithelial side up when in contact with the ocular surface. ProKera Plus® contains a double layer of CryoTek amniotic membrane tissue to provide extra therapeutic benefit. ProKera Plus® has several advantages over sutured AMT including ease of administration in a clinic setting and reduced overall procedural cost.
The role of ProKera® in the treatment algorithm of corneal ulcers has yet to be fully clarified. There are currently no prospective case studies comparing the use of ProKera® to standard of care conventional treatments in corneal ulcers. The utility of this device would provide valuable information in the treatment of bacterial corneal ulcers.
The objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Treatment | No Intervention |
After 48 hours of conventional treatment, consent will be obtained regarding the use of experimental treatment with ProKera Plus® versus continuing conventional method of treatment | |
| ProKera Plus® Treatment | Experimental | 1. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProProKera Plus® | Device | ProKera® is a sutureless form of CryoTek amniotic membrane that is clipped into a dual polycarbonate ring system with the epithelial side up when in contact with the ocular surface. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity - Visit 1 | Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. | 5-day Follow-Up, plus or minus 3 days |
| Visual Recovery - Visit 2 | Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. | 16-day follow-up plus or minus 5 days |
| Visual Recovery - Visit 3 | Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. | 30-day follow-up plus or minus 7 days |
| Visual Recovery - Visit 4 | Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. | 90 day follow-up plus or minus 10 days |
| Visual Recovery - Visit 5 | Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Re-epithelialization - Visit 1 | number of participants who had slit lamp photography which measured fluorescein staining size. | 5-day follow-up plus or minus 3 days |
| Corneal Re-epithelialization - Visit 2 |
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Inclusion Criteria:
Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Warrner, MD | University Of Arkansas For Medical Sciences, Jones Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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After at least 48 hours of conventional treatment, consent will be obtained regarding the use of experimental treatment with Prokera Plus versus continuing conventional treatment. This will be randomized in a 1:1 ratio by a block-randomization schedule to assign subjects to each of the two treatment groups. All three subjects that were screened were consented and assigned a group.
Total number of candidates screened and enrolled in study was 3. The goal of the study was to enroll 24 subjects, 12 subjects per group. Patients were recruited in the medical clinic (UAMS). recruitment started in November 2021 and ended in March 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Treatment |
After 48 hours of conventional treatment, consent will be obtained regarding the use of experimental treatment with ProKera Plus® versus continuing conventional method of treatment |
| FG001 | ProKera Plus® Treatment | 1. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer ProProKera Plus®: ProKera® is a sutureless form of CryoTek amniotic membrane that is clipped into a dual polycarbonate ring system with the epithelial side up when in contact with the ocular surface. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Treatment |
After 48 hours of conventional treatment, consent will be obtained regarding the use of experimental treatment with ProKera Plus® versus continuing conventional method of treatment |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Visual Acuity - Visit 1 | Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. | All randomized subjects regardless of actual treatment, with data at the 5-day Follow-up Evaluation. | Posted | Mean | Standard Deviation | LogMar | 5-day Follow-Up, plus or minus 3 days |
|
3 months
The adverse event led to severe corneal melting resulting in emergency cornea transplants for 2/2 patients who received Prokera.
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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 | Conventional Treatment |
After 48 hours of conventional treatment, consent will be obtained regarding the use of experimental treatment with ProKera Plus® versus continuing conventional method of treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Melt | Eye disorders | Systematic Assessment |
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This study was terminated early due to slow enrollment. There is not enough data collected for analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Warner | University of Arkansas for Medical Sciences | 501-686-5822 | DBwarner@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2021 | Mar 20, 2023 | Prot_SAP_000.pdf |
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Phase 1: This phase will establish baseline characteristics for each patient that is randomized into the treatment arm for the phase 2 part of the study.
Phase 2: This phase will test the intervention of using ProKera Plus® versus continuing conventional treatment for the corneal ulcer
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| 180-day follow-up plus or minus 14 days |
number of participants who had slit lamp photography which measured fluorescein staining size.
| 16-day follow-up plus or minus 5 days |
| Corneal Re-epithelialization - Visit 3 | number of participants who had slit lamp photography which measured fluorescein staining size. | 30-day follow-up plus or minus 7 days |
| Corneal Re-epithelialization - Visit 4 | number of participants who had slit lamp photography which measured fluorescein staining size. | 90-day follow-up plus or minus 10 days |
| Corneal Opacity Size - Visit 1 | number of participants who had anterior segment optical coherence tomography (ASOCT). | 5-day follow-up plus or minus 3 days |
| Corneal Opacity Size - Visit 3 | number of participants who had anterior segment optical coherence tomography (ASOCT). | 30-day follow-up plus or minus 7 days |
| Corneal Opacity Thinning-Visit 1 | number of participants who had anterior segment optical coherence tomography (ASOCT). | 5-day follow-up plus or minus 3 days |
| Corneal Opacity Thinning-Visit 3 | number of participants who had anterior segment optical coherence tomography (ASOCT). | 30-day follow-up plus or minus 7 days |
| Eye Pain- Visit 1 | Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) | 5-day follow-up plus or minus 3 days |
| Eye Pain- Visit 2 | Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) | 16-day follow-up plus or minus 5 days |
| Eye Pain- Visit 3 | Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) | 30-day follow-up plus or minus 7 days |
| Eye Pain- Visit 4 | Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) | 90-day follow-up plus or minus 10 days |
| Eye Pain- Visit 5 | Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) | 180-day follow-up plus or minus 14 days |
| BG001 | ProKera Plus® Treatment | 1. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer ProProKera Plus®: ProKera® is a sutureless form of CryoTek amniotic membrane that is clipped into a dual polycarbonate ring system with the epithelial side up when in contact with the ocular surface. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Vision Acuity at Baseline | Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. | Mean | Standard Deviation | LogMAR |
|
| OG001 | ProKera Plus® Treatment | 1. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer ProProKera Plus®: ProKera® is a sutureless form of CryoTek amniotic membrane that is clipped into a dual polycarbonate ring system with the epithelial side up when in contact with the ocular surface. |
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| Primary | Visual Recovery - Visit 2 | Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. | All randomized subjects regardless of actual treatment, with data at the 16-day Follow-up Evaluation. | Posted | Mean | Standard Deviation | LogMar | 16-day follow-up plus or minus 5 days |
|
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| Primary | Visual Recovery - Visit 3 | Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. | All randomized subjects regardless of actual treatment, with data at the 30-day Follow-up Evaluation. | Posted | Mean | Standard Deviation | LogMar | 30-day follow-up plus or minus 7 days |
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| Primary | Visual Recovery - Visit 4 | Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. | All randomized subjects regardless of actual treatment, with data at the 90-day Follow-up Evaluation. | Posted | Mean | Standard Deviation | LogMar | 90 day follow-up plus or minus 10 days |
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| Primary | Visual Recovery - Visit 5 | Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. | All randomized subjects regardless of actual treatment, with data at the 180-day Follow-up Evaluation. | Posted | Mean | Standard Deviation | LogMar | 180-day follow-up plus or minus 14 days |
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| Secondary | Corneal Re-epithelialization - Visit 1 | number of participants who had slit lamp photography which measured fluorescein staining size. | Posted | Number | participants | 5-day follow-up plus or minus 3 days |
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| Secondary | Corneal Re-epithelialization - Visit 2 | number of participants who had slit lamp photography which measured fluorescein staining size. | Posted | Number | participants | 16-day follow-up plus or minus 5 days |
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| Secondary | Corneal Re-epithelialization - Visit 3 | number of participants who had slit lamp photography which measured fluorescein staining size. | Posted | Count of Participants | Participants | 30-day follow-up plus or minus 7 days |
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| Secondary | Corneal Re-epithelialization - Visit 4 | number of participants who had slit lamp photography which measured fluorescein staining size. | Posted | Count of Participants | Participants | 90-day follow-up plus or minus 10 days |
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| Secondary | Corneal Opacity Size - Visit 1 | number of participants who had anterior segment optical coherence tomography (ASOCT). | Posted | Count of Participants | Participants | 5-day follow-up plus or minus 3 days |
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| Secondary | Corneal Opacity Size - Visit 3 | number of participants who had anterior segment optical coherence tomography (ASOCT). | Posted | Count of Participants | Participants | 30-day follow-up plus or minus 7 days |
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| Secondary | Corneal Opacity Thinning-Visit 1 | number of participants who had anterior segment optical coherence tomography (ASOCT). | Posted | Count of Participants | Participants | 5-day follow-up plus or minus 3 days |
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| Secondary | Corneal Opacity Thinning-Visit 3 | number of participants who had anterior segment optical coherence tomography (ASOCT). | Posted | Count of Participants | Participants | 30-day follow-up plus or minus 7 days |
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| Secondary | Eye Pain- Visit 1 | Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) | All randomized subjects regardless of actual treatment, with data at the 5-day Follow-up Evaluation. | Posted | Mean | Standard Deviation | score on a scale | 5-day follow-up plus or minus 3 days |
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| Secondary | Eye Pain- Visit 2 | Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) | All randomized subjects regardless of actual treatment, with data at the 16-day Follow-up Evaluation. | Posted | Mean | Standard Deviation | units on a scale | 16-day follow-up plus or minus 5 days |
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| Secondary | Eye Pain- Visit 3 | Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) | All randomized subjects regardless of actual treatment, with data at the 30-day Follow-up Evaluation. | Posted | Mean | Standard Deviation | units on a scale | 30-day follow-up plus or minus 7 days |
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| Secondary | Eye Pain- Visit 4 | Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) | All randomized subjects regardless of actual treatment, with data at the 90-day Follow-up Evaluation. | Posted | Mean | Standard Deviation | units on a scale | 90-day follow-up plus or minus 10 days |
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| Secondary | Eye Pain- Visit 5 | Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) | All randomized subjects regardless of actual treatment, with data at the 180-day Follow-up Evaluation. | Posted | Mean | Standard Deviation | units on a scale | 180-day follow-up plus or minus 14 days |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | ProKera Plus® Treatment | 1. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer ProProKera Plus®: ProKera® is a sutureless form of CryoTek amniotic membrane that is clipped into a dual polycarbonate ring system with the epithelial side up when in contact with the ocular surface. | 0 | 2 | 2 | 2 | 0 | 2 |
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