- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03069521
Study to Evaluate the Safety of the EndoArt™ for Treatment of Subjects Suffering From Corneal Edema
Prospective, Feasibility Study to Evaluate the Safety of the EndoArt™ for Treatment of Subjects Suffering From Corneal Edema
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Title: Prospective, feasibility study to evaluate the safety of the EndoArt® for treatment of subjects suffering from corneal edema
Device: EndoArt® (Artificial Endothelial Layer)
Intended Use: The EndoArt® device is intended for use as an endothelial kearatoprosthesis in patients with chronic cornel edema
Study Design: Prospective open-label feasibility clinical study
Study Objectives: To evaluate the safety of the EndoArt® implanted in subjects suffering from corneal edema.
Study Hypothesis: Treatment with the EndoArt® is safe and may result in alleviating symptoms resulting from chronic corneal edema (corneal thickness).
Study population: Men and women suffering from a decrease in vision due to chronic corneal edema that meet the inclusion/exclusion criteria and provide written Informed Consent will enrolled in the study.
Enrollment: A total of up to 30 subjects will be enrolled.
Study Duration: Completion of active enrollment is anticipated to last approximately 18 months. The primary end point will be achieved when the final study subject has completed 6 month follow up. Subject will be followed up to 12 month.
Primary Safety Endpoint: The frequency and severity of all treatment-related adverse events, during and after implantation of the EndoArt® and throughout the 6 month follow-up period. Adverse events will be assessed on a continuous basis from the procedure through the study completion at 6 months. Related adverse events include: corneal perforation, melting, uncontrolled inflammation, severe infection.
Secondary Efficacy Endpoints: Corneal thickness, Subjective corneal clarity, Pain as assessed by a Visual Analogue Scale (VAS) Measurement Best Corrected Distance Visual Acuity (BCDVA)
Study Treatment: Subjects will be implanted with the EndoArt®
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Heidelberg, Germany
- International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg
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Ashkelon, Israel
- Barzilai MC
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Be'er Sheva, Israel
- Soroka Medical Center
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Haifa, Israel
- Rambam Medical Center
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Tel Aviv, Israel
- Assuta Medical Center
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Tel Aviv, Israel
- Tel Aviv Souraski Medical Center
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Amsterdam, Netherlands
- AMC
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Barcelona, Spain
- IMO - Institut de Microcirurgia Ocular
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject is over 40 years old
- Subject with chronic corneal edema.
- Subject with corneal thickness >650 µm
- Subject with visual acuity 6/30 or worse (equivalent ETDRS)
- Subject with better visual acuity in the contralateral eye.
- Pseudophakic subject (anterior or posterior) with stable IOL.
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
Exclusion Criteria:
- Subject with best corrected visual acuity of 6/30 or worse in the fellow eye
- Subject with history of ocular Herpes keratitis
- Subject with severely scarred cornea (unfit for regular endothelial keratoplasty)
- Subject with irregular posterior cornea (e.g. post PKP)
- Subject who is suffering from infection of the cornea
- Patients with band keratopathy and/or limbal stem cell deficiency.
- Subject with clinical moderate to severe dry eye
- Subject with phthisis or phthisis suspect
- Subject with low ocular pressure ≤6 mmHg or higher than 25 mmHg.
- Subject with aphakica
- Subject with pseudophakodonesis
- Subject with large iris defect which can compromise intraoperative AC stability.
- Subjects after corneal refractive surgery.
- Subject with glaucoma shunt (e.g. Ahmend valve)
- Subject with neurotrophic corneal history
- Subject with history of persistent corneal erosion difficulties with epithelial growth (re-epithelization)
- Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: EndoArt®
EndoArt® Artificial Endothelial Layer
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device is intended for use as an endothelial kearatoprosthesis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-related adverse events
Time Frame: 6 months following EndoArt implantaion
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frequency and severity of all treatment-related adverse events
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6 months following EndoArt implantaion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective corneal clarity
Time Frame: 12 months following EndoArt implantaion
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corneal clarity will be graded by the investigator. Scoring is as follow:
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12 months following EndoArt implantaion
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Pain as assessed by a Visual Analogue Scale (VAS)
Time Frame: 12 months following EndoArt implantaion
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VAS is a horizontal line, 100 mm in length, anchored by word descriptors at each end. The subject marks on the line the point that he feels represents his perception of his current state. |
12 months following EndoArt implantaion
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Measurement Best Corrected Distance Visual Acuity (BCDVA)
Time Frame: 12 months following EndoArt implantaion
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Visual acuity on the distance chart with best manifest correction for that distance
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12 months following EndoArt implantaion
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Corneal thickness
Time Frame: 12 months following EndoArt implantaion
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Corneal thickness will be measured by anterior segment Optical Coherence Tomography (OCT).
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12 months following EndoArt implantaion
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECL00041
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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