Corneal EdemaNCT05139771
EndoArt® Implantation in Subjects With Chronic Corneal Edema
A study testing THE ENDOART® IMPLANTATION (Artificial Endothelial layer) in people with Corneal Edema, run by Eye-yon Medical at 12 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Corneal Edema
- What is being tested?
- THE ENDOART® IMPLANTATION (Artificial Endothelial layer)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 30 Sep 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 22Show fewer
- 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.
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
Georgia4 sites
Akhali Mzera Eye Clinic
Tbilisi
Caucasus Medical Center (CMC)
Tbilisi
Davinci Eye Medical Center
Tbilisi
High Technology Medical Center, University Clinic
Tbilisi
France2 sites
Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)
Brest, 29200
Hôpital Fondation A. de Rothschild
Paris
India2 sites
L V Prasad Eye Institute
Hyderabad, Telangana, 500034
Dr Agarwal's Eye Hospital
Tirunelveli, Tamil Nadu, 627003
Germany1 site
International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg
Heidelberg
About this study
Official title: 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).
Read the 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.
- Conditions
- Corneal Edema
- Being tested
- THE ENDOART® IMPLANTATION (Artificial Endothelial layer)
- Keywords
- Corneal edema, Chronic corneal edema, THE ENDOART®, Artificial Endothelial layer
- Medical subject headings
- Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THE ENDOART® IMPLANTATION (Artificial Endothelial layer)Device
Also called DSAEK, DMEK
Implantation of EndoArt® is similar to other anterior segment surgical procedures such as DSAEK/DMEK.
| Study group | Role | What they receive |
|---|---|---|
| EndoArt® Artificial Endothelial Layer | Other | 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®. Receives: Device: THE ENDOART® IMPLANTATION (Artificial Endothelial layer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of device related adverse events (safety)
Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.
Measured: 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.
Measured: 12 months
Secondary outcomes (5)
Change from baseline in central corneal thickness (CCT) postoperatively.
Central Corneal Thickness (pachymetry) will be measured by anterior segment Optical Coherence Tomography (OCT).
Measured: 6 months
Incidence of primary post-surgical detachment of the device.
Post implantation device detachment
Measured: 12 months
Rate of rebubbling post-op.
Number of times that post implantation re-bubbling is done
Measured: 12 months
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline.
Visual acuity will be measured with ETDRS format charts.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start30 Sep 2021
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye-yon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139771
- Sponsor's protocol ID
- CLI-E033
- Status last verified
- Feb 2023
- First submitted
- 20 Oct 2021
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Multicenter Phase 2 Clinical Safety Investigation of the EndoArt® Implantation in Subjects With Chronic Corneal Edema
- ClinicalTrials.gov ID
- NCT05139771
- Acronym / sponsor ID
- CLI-E033
- Conditions
- Corneal Edema
- Keywords
- Corneal edema, Chronic corneal edema, THE ENDOART®, Artificial Endothelial layer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eye-yon MedicalIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoArt® Artificial Endothelial Layer | Other | Device: THE ENDOART® IMPLANTATION (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®. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THE ENDOART® IMPLANTATION (Artificial Endothelial layer)Also: DSAEK, DMEKImplantation of EndoArt® is similar to other anterior segment surgical procedures such as DSAEK/DMEK. | Device | EndoArt® Artificial Endothelial Layer |
Primary outcome
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.
5 secondary outcomes
Change from baseline in central corneal thickness (CCT) postoperatively.
Time frame: 6 months
Incidence of primary post-surgical detachment of the device.
Time frame: 12 months
Rate of rebubbling post-op.
Time frame: 12 months
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline.
Time frame: 12 months
Change in ocular pain score as assessed by a Visual Analogue Scale (VAS) from baseline.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Corneal Edema
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The Belgian Endothelial Surgical Transplant of the Cornea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THE ENDOART® IMPLANTATION (Artificial Endothelial layer) in people with Corneal Edema, run by Eye-yon Medical at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Georgia, France, India, Israel, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of device related adverse events (safety) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.