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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis implantation but because of a history of corneal melts or autoimmune diseases are not candidate for a traditional corneal transplant.
The study is a multi-center, parallel, randomized, double-blinded study with subsequent follow-up period of two years. Eight-four subjects across twelve sites will be randomized 1:1 to receive either a corneal tissue that have been cross-linked or not cross-linked (No UVA light source). Cross-linking is a term that refers to the linking of polymers (long chain) molecules by chemical bonds. It is believed that cross-linking the cornea will make the cornea stronger and more resistant to degradation.
CorneaGen (formerly Keralink International) (Baltimore site) will supply the donor tissue and Avedro Inc (Waltham MA) will supply the riboflavin and the UV light source. Staff at CorneaGenwill administer the riboflavin with dextran solution and perform the cross-linking procedure according to one of randomization groups before shipping the masked donor cornea to study sites for Boston Keratoprosthesis (B-KPro) implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment Arm | Experimental | De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source). |
|
| Control Treatment Arm | Active Comparator | De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riboflavin | Drug | Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time From Surgery to Device Loss or Replacement | If the device fails after surgery the time and reason behind the failure will be recorded. The number of device losses in the control group will be compared to the number of device losses in investigational group. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Kpro Retention at 12 Months | The number of participants that retained kpro devices at the end of twelve months will be studied and differences in retention rate between investigational and control groups will be reported | Twelve months |
| Number of Cumulative Delayed Epithelial Healing Events at Day 30 |
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Inclusion Criteria:
Willing and able to provide written informed consent
Willing and able to comply with study assessments for the full duration of the study
Age ≥ 18 years
Candidate for a Boston Keratoprosthesis / Cornea transplant
In generally good stable overall health
Patients with an eye at risk for a cornea sterile ulcer which includes:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph B. Ciolino, MD | Massachusetts Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Jules Stein Eye Institute | Los Angeles | California | 90095-7003 | United States | ||
| UC Davis Health System Eye Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32557558 | Derived | Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2. |
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The data within StudyTrax will be extracted at the completion of the study. This data will be held in a secure network file at MEEI for at least two years following a marketing application submission to the FDA or longer, if required by the MEEI IRB.
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76 subjects enrolled - signed consent form
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment Arm | De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source). Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods. Dextran: Dextran is used to increase the viscosity of the solution. UVA Light Source: Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking. |
| 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 | Jan 10, 2020 | Jun 21, 2022 |
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|
| Dextran | Drug | Dextran is used to increase the viscosity of the solution. |
|
|
| UVA Light Source | Device | Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking. |
|
|
The number of incidences of delayed epithelial healing at day 30 will be recorded. If there is delayed epithelial healing at day 30 it will be determined if those incidences occurred more often in the control group versus the investigational group. |
| 30 days |
| Median Time From Surgery to Retroprosthetic Membrane Treatment in Days (Laser or Surgical Interventions) | If follow up surgery is needed to replace or treat the prosthetic the time and reason will be recorded and the number of incidences will be compared between the study treatment groups | 2 years |
| Median Time From Surgery to Occurrence of Vitritis (Sterile or Infectious) | The time (days) and number of incidences of vitritis will be recorded for the subject in which it occurred and the number of incidences will be compared between the study treatment groups. | 2 years |
| Sacramento |
| California |
| 95817 |
| United States |
| Shiley Eye Institute, University of California, San Diego | San Diego | California | 92093 | United States |
| Bascom Palmer eye Institute | Miami | Florida | 33136 | United States |
| Illinois Eye and Ear Infirmary | Chicago | Illinois | 60612 | United States |
| Cincinnati Eye Institute | Edgewood | Kentucky | 41017 | United States |
| Wilmer Eye Institute | Baltimore | Maryland | 21287 | United States |
| W.K. Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| David and Ilene Flaum Eye Institute, University of Rochester | New York | New York | 14642 | United States |
| University Hospitals Eye Institute | Cleveland | Ohio | 44106 | United States |
| Wills Eye | Bala-Cynwyd | Pennsylvania | 19007 | United States |
| Wilford Hall Ambulatory Surgical Center (WHASC) | Lackland Air Force Base | Texas | 78236 | United States |
| FG001 | Control Treatment Arm | De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light). Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods. Dextran: Dextran is used to increase the viscosity of the solution. |
|
| Screen Fail (Post Randomization) | Subject that did not meet eligibility criteria after the study randomization had occured. |
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| COMPLETED |
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| NOT COMPLETED |
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Participants receiving cross-linked (CXL) versus non-cross-linked (non-CXL) donor corneas (One subject who was randomized in the active arm (CXL corneal carrier) was excluded from efficacy analysis due to not meeting the inclusion criteria)
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment Arm | De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source). Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods. Dextran: Dextran is used to increase the viscosity of the solution. UVA Light Source: Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking. |
| BG001 | Control Treatment Arm | De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light). Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods. Dextran: Dextran is used to increase the viscosity of the solution. |
| BG002 | 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 |
| ||||||||||||||||
| Previous sterile keratolysis | Count of Participants | Participants |
| ||||||||||||||||
| Autoimmune disease | 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 | Time From Surgery to Device Loss or Replacement | If the device fails after surgery the time and reason behind the failure will be recorded. The number of device losses in the control group will be compared to the number of device losses in investigational group. | Posted | Median | Inter-Quartile Range | median weeks from surgery to removal | 2 years |
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| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Kpro Retention at 12 Months | The number of participants that retained kpro devices at the end of twelve months will be studied and differences in retention rate between investigational and control groups will be reported | Posted | Count of Participants | Participants | Twelve months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Cumulative Delayed Epithelial Healing Events at Day 30 | The number of incidences of delayed epithelial healing at day 30 will be recorded. If there is delayed epithelial healing at day 30 it will be determined if those incidences occurred more often in the control group versus the investigational group. | Posted | Count of Participants | Participants | 30 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Median Time From Surgery to Retroprosthetic Membrane Treatment in Days (Laser or Surgical Interventions) | If follow up surgery is needed to replace or treat the prosthetic the time and reason will be recorded and the number of incidences will be compared between the study treatment groups | Posted | Median | Standard Deviation | median time (days) from surgery to RPM | 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Median Time From Surgery to Occurrence of Vitritis (Sterile or Infectious) | The time (days) and number of incidences of vitritis will be recorded for the subject in which it occurred and the number of incidences will be compared between the study treatment groups. | Posted | Median | Standard Deviation | median time (days) surgery to vitritis | 2 years |
|
Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants).
Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
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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 | Active Treatment Arm | De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source). Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods. Dextran: Dextran is used to increase the viscosity of the solution. UVA Light Source: Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking. | 1 | 34 | 6 | 34 | 17 | 34 |
| EG001 | Control Treatment Arm | De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light). Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods. Dextran: Dextran is used to increase the viscosity of the solution. | 0 | 34 | 10 | 34 | 16 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Eye disorders | Non-systematic Assessment |
|
| |
| Corneal Melt | Eye disorders | Non-systematic Assessment | Corneal Melt |
| |
| High Intraocular Pressure | Eye disorders | Non-systematic Assessment | High Intraocular Pressure |
| |
| Choroidal Detachment | Eye disorders | Non-systematic Assessment | Choroidal Detachment |
| |
| Endophthalmitis | Eye disorders | Non-systematic Assessment | Endophthalmitis (right eye) |
| |
| Retinal Detachment | Eye disorders | Non-systematic Assessment |
| ||
| Complication of corneal transplant | Eye disorders | Non-systematic Assessment | Complication of corneal transplant (gap between front plate and donor) |
| |
| Persistent Epithelial Defect | Eye disorders | Non-systematic Assessment | Persistent Epithelial Defect |
| |
| Epiretinal membrane | Eye disorders | Non-systematic Assessment | Epiretinal membrane |
| |
| Wound Dehiscence | Eye disorders | Non-systematic Assessment | Wound Dehiscence |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retroprosthetic Membrane | Eye disorders | Non-systematic Assessment | Retroprosthetic Membrane |
| |
| Vitreous | Eye disorders | Non-systematic Assessment | Vitreous hemorrhage |
| |
| Corneal Thinning | Eye disorders | Non-systematic Assessment | Corneal thinning |
| |
| EPI Defect | Eye disorders | Non-systematic Assessment | Epi defect |
| |
| High Intraocular Pressure | Eye disorders | Non-systematic Assessment | High Intraocular Pressure |
| |
| Eye Pain (discomfort) | Eye disorders | Non-systematic Assessment | Eye Pain (discomfort) |
| |
| Loose suture | Eye disorders | Non-systematic Assessment | Loose suture |
| |
| Hemmorrge | Eye disorders | Non-systematic Assessment | Hemmorrge |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Odeta Dyrmishi & Joseph Ciolino | Massachusetts Eye and Ear | 7742745014 | Odeta_Dyrmishi@meei.harvard.edu; Joseph_Ciolino@meei.harvard.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2022 | Jan 26, 2023 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D012256 | Riboflavin |
| D003911 | Dextrans |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
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| Male |
|
| 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 |
|
| White |
|
| More than one race |
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| Unknown or Not Reported |
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| Rheumatoid Arthritis |
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| Graft Versus Host Disease |
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| Mucus Membrane Pemphigoid |
|
| Vogt-Koyangi-Harada Syndrome |
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