Back to resultsEndoArt® Implantation in Subjects With Chronic Corneal Edema
Primary Purpose
Corneal Edema
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
THE ENDOART® IMPLANTATION (Artificial Endothelial layer)
Sponsored by
About this trial
This is an interventional other trial for Corneal Edema focused on measuring Corneal edema, Chronic corneal edema, THE ENDOART®, Artificial Endothelial layer
Eligibility Criteria
Inclusion Criteria:
Individuals must meet the following inclusion criteria at screening visit:
- Male or Female subjects 40-85 years of age.
- Have chronic corneal edema (for a minimum of 3 months) secondary to endothelial dysfunction.
- Have corneal thickness >600μm by OCT.
- Have best corrected distance visual acuity 6/19 (20/63) or worse (equivalent ETDRS= 60 letters) with subjective symptoms of impaired visual function.
- Subject with posterior pseudophakia and stable IOL.
- Willing and able to understand and sign informed consent prior to any study related procedure.
- Willing and able to follow study instructions (e.g., to lay on one's back for 4 hours post op), able to self-administer or have caregiver available to administer eyedrops as required by the protocol for the duration of the study, and able to attend study visits/assessments for the duration of the study.
Exclusion Criteria:
Individuals for participation will be ineligible for the study if any of the following conditions apply:
- History of ocular Herpetic keratitis.
- Scarred cornea resulting in visual impairment with intact endothelium (cell density ≥ 1500).
- History of posterior vitrectomy.
- Post PKP
- Have an irregular posterior cornea (e.g., post trauma).
- Have a current infection of the cornea.
- Have band keratopathy and/or limbal stem cell deficiency.
- Have clinically severe dry eye disease which needs more than 4 drops of lubricant per day.
- Phthisis bulbi or subject is at risk of developing phthisis.
- Subject with medically uncontrolled high intra ocular pressure.
- Aphakia.
- Anterior chamber IOL or fixated anterior chamber IOL.
- Pseudophakodonesis.
- Have large iris defect which could compromise intraoperative air bubble formation
- Have undergone corneal refractive surgery.
- History of neurotrophic cornea.
- History of recurrent corneal erosion or persistent epithelial defect.
- IridoCorneal Endothelial (ICE) Syndrome or any rare disease/ syndrome creating anatomical or physiological anomalies of the anterior chamber (e.g., corectopia).
- Recurrent posterior, intermediate or anterior uveitis.
- Subject receiving regular intravitreal injection
- Currently participating or have participated in an investigational study, other than this study, within the past 60 days.
Sites / Locations
- Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)
- Hôpital Fondation A. de Rothschild
- Akhali Mzera Eye Clinic
- Caucasus Medical Center (CMC)
- Davinci Eye Medical Center
- High Technology Medical Center, University Clinic
- International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg
- Dr Agarwal's Eye Hospital
- L V Prasad Eye Institute
- Rambam Medical Center
- Assuta HaShalom
- Amsterdam MC (AMC)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
EndoArt® Artificial Endothelial Layer
Arm Description
EndoArt® is intended to be used as an endothelial prosthesis in patients with chronic corneal edema. One arm - all subjects will be implanted with EndoArt®.
Outcomes
Primary Outcome Measures
The frequency of device related adverse events (safety)
Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.
The severity of device related adverse events (safety).
Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.
Secondary Outcome Measures
Change from baseline in central corneal thickness (CCT) postoperatively.
Central Corneal Thickness (pachymetry) will be measured by anterior segment Optical Coherence Tomography (OCT).
Incidence of primary post-surgical detachment of the device.
Post implantation device detachment
Rate of rebubbling post-op.
Number of times that post implantation re-bubbling is done
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline.
Visual acuity will be measured with ETDRS format charts.
Change in ocular pain score as assessed by a Visual Analogue Scale (VAS) from baseline.
VAS is a horizontal line, 0-100 mm. VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the subject marks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05139771
Brief Title
EndoArt® Implantation in Subjects With Chronic Corneal Edema
Official Title
An Open-label Multicenter Phase 2 Clinical Safety Investigation of the EndoArt® Implantation in Subjects With Chronic Corneal Edema
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye-yon Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The EndoArt® is intended to be used as an endothelial prosthesis in patients with chronic corneal edema.The EndoArt® (Artificial Endothelial layer) is a permanent implant, constructed of a clear, transparent, foldable, biologically compatible copolymer of hydroxyethyl methacrylate and methyl methacrylate. The peripheral surface of the EndoArt® has either one or more marks, to ensure the correct orientation of the implant. The device serves as a physical barrier blocking the influx of water from the AC of the eye into the cornea due to dysfunctional corneal endothelial layer. Together with evaporation from the anterior surface of the cornea it maintains corneal hydration and clarity.
The EndoArt® device is CE marked approved (approved for marketing by the European regulatory authority).
Detailed Description
This study is a prospective, multicenter, open-label, phase 2 clinical investigation assessing safety of EndoArt® implantation, in subjects with chronic corneal edema. Safety will be assessed by evaluating the rate of adverse events and adverse device effects throughout the study period. Exploratory efficacy endpoints will be assessed by measuring the change in corneal thickness from baseline, change in pain score from baseline and changes in visual acuity. Time to, and rate of, post-surgical rebubbling to facilitate adhesion of the device will be explored.
Subjects with chronic corneal edema that meet the inclusion/exclusion criteria will be the study target population. The study will encompass a total of up to 80 subjects who will complete the Protocol follow-up schedule. For the Primary endpoint, the frequency and severity of device related adverse events, from patient entry through the 6-month follow-up period will be analyzed. Adverse events will be assessed on a continuous basis and will continue to be collected for 12 months.
This clinical investigation is conducted in up to 12 (twelve) clinical sites in Europe (Germany, France, and Netherlands), Mexico, India and Israel. Additional sites may be considered.
This clinical investigation has been designed to provide continuous clinical evidence for the EndoArt® as part of its clinical follow up program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Edema
Keywords
Corneal edema, Chronic corneal edema, THE ENDOART®, Artificial Endothelial layer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EndoArt® Artificial Endothelial Layer
Arm Type
Other
Arm Description
EndoArt® is intended to be used as an endothelial prosthesis in patients with chronic corneal edema. One arm - all subjects will be implanted with EndoArt®.
Intervention Type
Device
Intervention Name(s)
THE ENDOART® IMPLANTATION (Artificial Endothelial layer)
Other Intervention Name(s)
DSAEK, DMEK
Intervention Description
Implantation of EndoArt® is similar to other anterior segment surgical procedures such as DSAEK/DMEK.
Primary Outcome Measure Information:
Title
The frequency of device related adverse events (safety)
Description
Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.
Time Frame
12 months
Title
The severity of device related adverse events (safety).
Description
Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline in central corneal thickness (CCT) postoperatively.
Description
Central Corneal Thickness (pachymetry) will be measured by anterior segment Optical Coherence Tomography (OCT).
Time Frame
6 months
Title
Incidence of primary post-surgical detachment of the device.
Description
Post implantation device detachment
Time Frame
12 months
Title
Rate of rebubbling post-op.
Description
Number of times that post implantation re-bubbling is done
Time Frame
12 months
Title
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline.
Description
Visual acuity will be measured with ETDRS format charts.
Time Frame
12 months
Title
Change in ocular pain score as assessed by a Visual Analogue Scale (VAS) from baseline.
Description
VAS is a horizontal line, 0-100 mm. VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the subject marks.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals must meet the following inclusion criteria at screening visit:
Male or Female subjects 40-85 years of age.
Have chronic corneal edema (for a minimum of 3 months) secondary to endothelial dysfunction.
Have corneal thickness >600μm by OCT.
Have best corrected distance visual acuity 6/19 (20/63) or worse (equivalent ETDRS= 60 letters) with subjective symptoms of impaired visual function.
Subject with posterior pseudophakia and stable IOL.
Willing and able to understand and sign informed consent prior to any study related procedure.
Willing and able to follow study instructions (e.g., to lay on one's back for 4 hours post op), able to self-administer or have caregiver available to administer eyedrops as required by the protocol for the duration of the study, and able to attend study visits/assessments for the duration of the study.
Exclusion Criteria:
Individuals for participation will be ineligible for the study if any of the following conditions apply:
History of ocular Herpetic keratitis.
Scarred cornea resulting in visual impairment with intact endothelium (cell density ≥ 1500).
History of posterior vitrectomy.
Post PKP
Have an irregular posterior cornea (e.g., post trauma).
Have a current infection of the cornea.
Have band keratopathy and/or limbal stem cell deficiency.
Have clinically severe dry eye disease which needs more than 4 drops of lubricant per day.
Phthisis bulbi or subject is at risk of developing phthisis.
Subject with medically uncontrolled high intra ocular pressure.
Aphakia.
Anterior chamber IOL or fixated anterior chamber IOL.
Pseudophakodonesis.
Have large iris defect which could compromise intraoperative air bubble formation
Have undergone corneal refractive surgery.
History of neurotrophic cornea.
History of recurrent corneal erosion or persistent epithelial defect.
IridoCorneal Endothelial (ICE) Syndrome or any rare disease/ syndrome creating anatomical or physiological anomalies of the anterior chamber (e.g., corectopia).
Recurrent posterior, intermediate or anterior uveitis.
Subject receiving regular intravitreal injection
Currently participating or have participated in an investigational study, other than this study, within the past 60 days.
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Hôpital Fondation A. de Rothschild
City
Paris
Country
France
Facility Name
Akhali Mzera Eye Clinic
City
Tbilisi
Country
Georgia
Facility Name
Caucasus Medical Center (CMC)
City
Tbilisi
Country
Georgia
Facility Name
Davinci Eye Medical Center
City
Tbilisi
Country
Georgia
Facility Name
High Technology Medical Center, University Clinic
City
Tbilisi
Country
Georgia
Facility Name
International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Dr Agarwal's Eye Hospital
City
Tirunelveli
State/Province
Tamil Nadu
ZIP/Postal Code
627003
Country
India
Facility Name
L V Prasad Eye Institute
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500034
Country
India
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Assuta HaShalom
City
Tel Aviv
Country
Israel
Facility Name
Amsterdam MC (AMC)
City
Amsterdam
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EndoArt® Implantation in Subjects With Chronic Corneal Edema
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