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EndoArt® Implantation in Subjects With Chronic Corneal Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05139771
Recruitment Status : Recruiting
First Posted : December 1, 2021
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Eye-yon Medical

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).


Condition or disease Intervention/treatment Phase
Corneal Edema Device: THE ENDOART® IMPLANTATION (Artificial Endothelial layer) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-label Multicenter Phase 2 Clinical Safety Investigation of the EndoArt® Implantation in Subjects With Chronic Corneal Edema
Actual Study Start Date : September 30, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The frequency of device related adverse events (safety) [ Time Frame: 12 months ]
    Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.

  2. The severity of device related adverse events (safety). [ Time Frame: 12 months ]
    Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.


Secondary Outcome Measures :
  1. Change from baseline in central corneal thickness (CCT) postoperatively. [ Time Frame: 6 months ]
    Central Corneal Thickness (pachymetry) will be measured by anterior segment Optical Coherence Tomography (OCT).

  2. Incidence of primary post-surgical detachment of the device. [ Time Frame: 12 months ]
    Post implantation device detachment

  3. Rate of rebubbling post-op. [ Time Frame: 12 months ]
    Number of times that post implantation re-bubbling is done

  4. Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline. [ Time Frame: 12 months ]
    Visual acuity will be measured with ETDRS format charts.

  5. Change in ocular pain score as assessed by a Visual Analogue Scale (VAS) from baseline. [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05139771


Contacts
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Contact: Malca Chen-Zion, Ph.D +972-73-7803607 malca@eye-yon.com
Contact: Iris Shalev, DVM +972-73-7803607 iris@eye-yon.com

Locations
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France
Centre Hospitalier Régional Universitaire de Brest (CHRU Brest) Recruiting
Brest, France, 29200
Contact: Prof. Béatrice Cochener, MD       beatrice.cochener@ophtalmologie-chu29.fr   
Hôpital Fondation A. de Rothschild Recruiting
Paris, France
Contact: Prof. Eric Gabison, MD       egabison@for.paris   
Georgia
Akhali Mzera Eye Clinic Recruiting
Tbilisi, Georgia
Contact: Merab Dvali, Prof. MD         
Contact: Monika Zalinian, MD       monikazalinyan@gmail.com   
Caucasus Medical Center (CMC) Recruiting
Tbilisi, Georgia
Contact: Prof. Mikheil Omiadze, MD       m.omiadze@cmchospital.ge   
Contact: Dr. Sopio Tsiklauri, MD       stsiklauri@cmchospital.ge   
Davinci Eye Medical Center Recruiting
Tbilisi, Georgia
Contact: Dr. Nicoloz Labauri, MD       nlabauri@yahoo.com   
Contact: Tekla Mamageishvili, MD       teklann@gmail.com   
High Technology Medical Center, University Clinic Recruiting
Tbilisi, Georgia
Contact: Ana Dvalishvili, MD         
Contact: Anna Khokhiashvili, MD       SOFI777@mail.ru   
Germany
International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany
Contact: Gerd U. Auffarth, Prof. MD         
Contact: Raquel Willrich Amroussi, M.A.       raquel.willrichamroussi@med.uni-heidelberg.de   
India
Dr Agarwal's Eye Hospital Recruiting
Tirunelveli, Tamil Nadu, India, 627003
Contact: Prof. Lional Raj, MD       drlionalraj@dragarwal.com   
L V Prasad Eye Institute Recruiting
Hyderabad, Telangana, India, 500034
Contact: Dr. Sunita Chaurasia, MD       sunita@lvpei.org   
Contact: Kalpana Baspoji       kalpana@lvpei.org   
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Modi Naftali, MD.       m_naftali@rambam.health.gov.il   
Assuta HaShalom Recruiting
Tel Aviv, Israel
Contact: Israel Leshem, MD.       israell@assuta.co.il   
Netherlands
Amsterdam MC (AMC) Not yet recruiting
Amsterdam, Netherlands
Contact: Ruth Lapid- Gortzak, MD         
Contact: Monique Wezel       m.wezel@amsterdamumc.nl   
Sponsors and Collaborators
Eye-yon Medical
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Responsible Party: Eye-yon Medical
ClinicalTrials.gov Identifier: NCT05139771    
Other Study ID Numbers: CLI-E033
First Posted: December 1, 2021    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eye-yon Medical:
Corneal edema
Chronic corneal edema
THE ENDOART®
Artificial Endothelial layer
Additional relevant MeSH terms:
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Corneal Edema
Edema
Corneal Diseases
Eye Diseases