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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07344168 · CLI-E053

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗