EndoArt® Implantation in Subjects With Chronic Corneal Edema
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|ClinicalTrials.gov Identifier: NCT05139771|
Recruitment Status : Recruiting
First Posted : December 1, 2021
Last Update Posted : May 10, 2022
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|
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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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).
- Incidence of primary post-surgical detachment of the device. [ Time Frame: 12 months ]Post implantation device detachment
- Rate of rebubbling post-op. [ Time Frame: 12 months ]Number of times that post implantation re-bubbling is done
- Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline. [ Time Frame: 12 months ]Visual acuity will be measured with ETDRS format charts.
- 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.
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
|Contact: Malca Chen-Zion, Ph.Demail@example.com|
|Contact: Iris Shalev, DVMfirstname.lastname@example.org|
|Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)||Recruiting|
|Brest, France, 29200|
|Contact: Prof. Béatrice Cochener, MD email@example.com|
|Hôpital Fondation A. de Rothschild||Recruiting|
|Contact: Prof. Eric Gabison, MD firstname.lastname@example.org|
|Akhali Mzera Eye Clinic||Recruiting|
|Contact: Merab Dvali, Prof. MD|
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|Caucasus Medical Center (CMC)||Recruiting|
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|Contact: Dr. Sopio Tsiklauri, MD email@example.com|
|Davinci Eye Medical Center||Recruiting|
|Contact: Dr. Nicoloz Labauri, MD firstname.lastname@example.org|
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|High Technology Medical Center, University Clinic||Recruiting|
|Contact: Ana Dvalishvili, MD|
|Contact: Anna Khokhiashvili, MD SOFI777@mail.ru|
|International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg||Recruiting|
|Contact: Gerd U. Auffarth, Prof. MD|
|Contact: Raquel Willrich Amroussi, M.A. firstname.lastname@example.org|
|Dr Agarwal's Eye Hospital||Recruiting|
|Tirunelveli, Tamil Nadu, India, 627003|
|Contact: Prof. Lional Raj, MD email@example.com|
|L V Prasad Eye Institute||Recruiting|
|Hyderabad, Telangana, India, 500034|
|Contact: Dr. Sunita Chaurasia, MD firstname.lastname@example.org|
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|Rambam Medical Center||Recruiting|
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|Tel Aviv, Israel|
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|Amsterdam MC (AMC)||Not yet recruiting|
|Contact: Ruth Lapid- Gortzak, MD|
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