EndoArt® Implantation in Subjects With Chronic Corneal Edema

An Open-label Multicenter Phase 2 Clinical Safety Investigation of the EndoArt® Implantation in Subjects With Chronic Corneal Edema

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Corneal Edema
• Intervention / Treatment: Device: THE ENDOART® IMPLANTATION (Artificial Endothelial layer)

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)
  • Paris, France
    • Hôpital Fondation A. de Rothschild
• Georgia
  • Tbilisi, Georgia
    • High Technology Medical Center, University Clinic
  • Tbilisi, Georgia
    • Akhali Mzera Eye Clinic
  • Tbilisi, Georgia
    • Caucasus Medical Center (CMC)
  • Tbilisi, Georgia
    • Davinci Eye Medical Center
• Germany
  • Heidelberg, Germany
    • International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg
• India
  • Tamil Nadu
    • Tirunelveli, Tamil Nadu, India, 627003
      • Dr Agarwal's Eye Hospital
  • Telangana
    • Hyderabad, Telangana, India, 500034
      • L V Prasad Eye Institute
• Israel
  • Haifa, Israel
    • Rambam Medical Center
  • Tel Aviv, Israel
    • Assuta HaShalom
• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam MC (AMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Individuals must meet the following inclusion criteria at screening visit:

1. Male or Female subjects 40-85 years of age.
2. Have chronic corneal edema (for a minimum of 3 months) secondary to endothelial dysfunction.
3. Have corneal thickness >600μm by OCT.
4. Have best corrected distance visual acuity 6/19 (20/63) or worse (equivalent ETDRS= 60 letters) with subjective symptoms of impaired visual function.
5. Subject with posterior pseudophakia and stable IOL.
6. Willing and able to understand and sign informed consent prior to any study related procedure.
7. 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:

1. History of ocular Herpetic keratitis.
2. Scarred cornea resulting in visual impairment with intact endothelium (cell density ≥ 1500).
3. History of posterior vitrectomy.
4. Post PKP
5. Have an irregular posterior cornea (e.g., post trauma).
6. Have a current infection of the cornea.
7. Have band keratopathy and/or limbal stem cell deficiency.
8. Have clinically severe dry eye disease which needs more than 4 drops of lubricant per day.
9. Phthisis bulbi or subject is at risk of developing phthisis.
10. Subject with medically uncontrolled high intra ocular pressure.
11. Aphakia.
12. Anterior chamber IOL or fixated anterior chamber IOL.
13. Pseudophakodonesis.
14. Have large iris defect which could compromise intraoperative air bubble formation
15. Have undergone corneal refractive surgery.
16. History of neurotrophic cornea.
17. History of recurrent corneal erosion or persistent epithelial defect.
18. IridoCorneal Endothelial (ICE) Syndrome or any rare disease/ syndrome creating anatomical or physiological anomalies of the anterior chamber (e.g., corectopia).
19. Recurrent posterior, intermediate or anterior uveitis.
20. Subject receiving regular intravitreal injection
21. 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: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EndoArt® Artificial Endothelial Layer; 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®.	Device: THE ENDOART® IMPLANTATION (Artificial Endothelial layer); Implantation of EndoArt® is similar to other anterior segment surgical procedures such as DSAEK/DMEK.; Other Names: DSAEK; DMEK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of device related adverse events (safety)	Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.	12 months
The severity of device related adverse events (safety).	Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in central corneal thickness (CCT) postoperatively.	Central Corneal Thickness (pachymetry) will be measured by anterior segment Optical Coherence Tomography (OCT).	6 months
Incidence of primary post-surgical detachment of the device.	Post implantation device detachment	12 months
Rate of rebubbling post-op.	Number of times that post implantation re-bubbling is done	12 months
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline.	Visual acuity will be measured with ETDRS format charts.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: Eye-yon Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Corneal edema; Chronic corneal edema; THE ENDOART®; Artificial Endothelial layer
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Edema; Corneal Edema
• Other Study ID Numbers: CLI-E033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No