EndoArt® Implantation in Subjects With Chronic Corneal Edema - US Study

Official title

A Prospective, Open-label, Single Arm Study to Evaluate the Safety and Effectiveness of the EndoArt® in Subjects With Chronic Corneal Edema in Whom Multiple Prior Keratoplasty (EK/PK) Have Failed, and Who Are Not Reasonable Candidates for Any Form of Corneal Transplant, Including Penetrating Keratoplasty

Overview

The EndoArt® device is intended to treat patients with chronic corneal edema due to endothelial dysfunction, in whom prior multiple keratoplasty (EK/PK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty. The EndoArt® (Corneal Artificial Endothelial layer) is a permanent synthetic implant. It is made of a clear, transparent, foldable, biologically compatible hydrophilic copolymer. The device serves as an inert physical barrier, blocking the ingress of fluid from the Anterior Chamber (AC) into the cornea.

Detailed description

The study is a prospective, multi-center, open-label, single arm pivotal clinical investigation. The objective is to evaluate the safety and effectiveness of EndoArt® implantation in subjects with chronic corneal edema, in whom multiple prior keratoplasty (EK/PK) procedures have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty.

Safety will be assessed by evaluating the rate of any device related SAE occurred through the 12-month follow-up period.

The primary effectiveness endpoint is the proportion of subjects achieving an improvement in visual acuity of at least 0.20 LogMAR for subjects with baseline BCVA better than 1.30 LogMAR, or an improvement to at least 1.30 LogMAR for subjects with baseline BCVA equal or worse than 1.30 LogMAR, at 12 months postoperatively.

Subjects with chronic corneal edema, in whom multiple prior keratoplasty (EK/PK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty will be the study target population.

Only subjects who have signed the informed consent form and meet all the eligibility criteria listed below will be qualified for enrollment. The study will include a total of 123 surgically treated subjects. This clinical investigation will be conducted in a maximum of fifteen (20) clinical sites in the USA.

Interventions

• Device The EndoArt® (Corneal Artificial Endothelial layer)
  Implantation of EndoArt® is similar to other anterior segment surgical procedures such as DSEK/DMEK

Primary outcome measures

• The rate of any device related SAE [Time frame: 12 months]
• Improvement in visual acuity as measured by BCVA [Time frame: 12 months]

Secondary outcome measures (8)

• All AE rate [Time frame: 12 months]
• BCVA Success rate [Time frame: 12 months]
• CCT [Time frame: 12 months]
• Change in manifest refraction [Time frame: 12 months]
• Corneal clarity [Time frame: 12 months]
• Distribution of BCVA change [Time frame: 12 months]
• Distribution of BCVA outcomes (using FrACT10) [Time frame: 12 months]
• BCVA Success rate [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

• Male or female subjects 30-85 years of age.
• Have chronic corneal edema (lasting at least 3 months) and have experienced at least 3 prior keratoplasty (EK/PK) failures.
• Is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.
• CCT of 650-1200 μm, not including DSAEK thickness.

\* In cases where the treated eye has undergone PKP, or if the corneal thickness of the contralateral eye cannot be measured (e.g., monocular patient, or if the contralateral eye has corneal edema or a history of PKP), the CCT of the study eye must be between 700-1200 μm.

• Pseudophakia
• Cornea WTW between 10-13 mm
• IOP <20 mmHg and IOP≥8 mmHg
• BCVA of the study eye equal or worse than 0.50 LogMAR and up to 2.40 LogMAR (Hand motion is between 2.20-2.40 LogMAR).
• Must have better visual acuity in the contralateral eye, which must be at least 0.20 LogMAR better than the treated eye and have a visual acuity of at least 1.00 LogMAR.
• Central general clarity grade ≥2 (See Table 14. Central general clarity grading)
• 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 at least 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

• No light perception or light perception.
• Opaque scar in the visual axis that is indicated for PKP.
• Irregular posterior cornea (e.g. post trauma) in the 6.5 mm central part of the cornea (EndoArt® diameter).
• Current infection of the cornea.
• Central Band keratopathy and/or limbal stem cell deficiency.
• Diagnosis of: Sjogren's Syndrome, GVHD.
• PUK (peripheral ulcerative keratitis)
• Phthisis bulbi or subject is at high risk of developing phthisis (Hypothony).
• History of corneal refractive surgery: LASIK, PRK, SMILE, Epi-keratoplasty (or any anterior lamellar keratoplasty, inlays) and Radial Keratotomy (RK).
• Severe corneal distortion e.g.: keratoconus, pellucid marginal degeneration or keratoglobus (not relevant post PKP).
• Subject with medically uncontrolled intra ocular pressure, which requires surgical intervention.
• Aphakia.
• Active inflammation, or active, recurrent, or Chronic Uveitis
• Dislocation or partial dislocation of the IOL.
• Have large iris defect (more than 90 degrees) which could compromise intraoperative air bubble formation, excluding inferior defect.
• Severe ptosis (middle of pupil or covering the pupil entirely).
• Subject receiving regular intravitreal injection.
• History of persistent/ recurrent corneal erosion or persistent epithelial defect with difficulties in epithelial re-growth (erosion more than 2 months).
• History of ocular herpetic keratitis
• Current retinal detachments
• Advanced optic nerve cupping (defined as a cup-disc ratio of 0.9 or greater).
• Posterior segment masses or other acute significant posterior segment pathology (e.g., active age-related macular degeneration or chronic cystoid macular edema).
• Afferent Pupillary Defect (APD)
• Fellow eye CCT < 500 µm
• Any other acute ocular condition
• Bilateral implantation of the EndoArt®
• Posterior vitrectomy (anterior vitrectomy is allowed)
• Subjects with mental impairment
• Subject with history of spontaneous corneal perforations.
• Pregnant or lactating women, or with childbirth plans during the clinical trial
• Currently participating or have participated in an investigational study, other than this study, within the past 60 days.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07344168 · CLI-E053

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗