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Clinical Trials in Germany / NCT05870566
Recruiting Not applicable

Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]

NCT05870566 · tracked via the Priya Life Science Germany tracker
Sponsor
Claus Cursiefen
Phase
Not applicable
Started
2023-11-20
Last updated
2024-10-21

Condition(s) studied

Corneal Transplantation

Investigational drug(s) / intervention(s)

Corneal Crosslinking

Corneal Crosslinking: Riboflavin isotonic, 0,1 % Vitamin B2, with Dextran 20,0%, for epi-off procedure or Riboflavin isotonic 0,1% (Vitamin B2), 1,1% HPMC without Dextran for epi-off) 0.1% riboflavin-5-phosphate and 20% dextran T-500) will be applied to the cornea after epithelial debridement every 2 min for 10 minutes before irradiation and every 2 minutes during the course of a 10 minute exposure to 365 nm UV-A with an irradiance rate of 9 mW/cm2. This dose, mode and scheme of the intervention follows the internationally recognized "accelerated CXL protocol" (Elbaz et al. 2014). The data existing shows equivalent outcome regarding efficacy and safety compared to the standard protocol. To avoid any damage to the limbal stem cells, the limbus will not be irradiated during the procedure, as a CXL device (with maximal diameter of 11 mm) will be used. Furthermore, the limbal area will additionally be protected by a custom-cut LSC protection shield. (Protocol V04\_0 Page 45-46)

Study summary

The trial evaluates the effect of corneal crosslinking as pre-treatment before corneal transplantation. The goal is to improve graft survival by reducing pathological vessels through pre-treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Medical condition or disease to be investigated: \- Pathologically prevascularized cornea with need for corneal transplantation Further inclusion criteria: * Written informed consent by subject and/or witness prior to any study-related procedures * Adult male and female subjects ≥ 18 years old * ≥ 2 corneal quadrants covered by pathological corneal neovascularization * Absence of other clinical contraindications to any part or product of the treatment plan * A cooperative attitude to follow up the study procedures * In case of bilateral disease only one eye will be included * Steroid responders with adequate control regiment or local/systemic therapy can be included Exclusion Criteria: * \< 2 corneal quadrants covered by pathological neovascularization * Corneal stromal thickness below 400 μm (except in the central 8 mm zone which will be replaced later by a new corneal transplant with new endothelium); peripheral stromal thinning below 400 μm in weakened recipient areas is acceptable for CXL if not affecting more than 50% of the corneal circumference (allowing for later endothelial repopulation) * Active or suspected intraocular inflammation * Active corneal ulceration * Compromised eyelid mobility and/or symblepharon * Allergy, sensitivity or intolerance to riboflavin or UV * Contraindications, other than steroid response to the local or systemic antibiotics and/or corticosteroids (other than steroid response) foreseen by the protocol * Contraindications to the surgical protocol * Clinically significant or unstable concurrent disease or other medical condition affecting grafting procedure * Rheumatic diseases treated with systemic immunosuppressive medication * Subjects unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study procedures and treatments * Participation in another clinical trial where an investigational drug was received less than 4 weeks prior to screening visit * Positive for human immunodeficiency virus (HIV) * Known abuse of alcohol, drugs, or medicinal products * Evidence of any other medical conditions (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the subject's compliance, or place the subject at high risk of complications related to the treatment * Employees of the sponsor, or employees or relatives of the investigator. * Pregnant women and nursing mothers as corneal transplantation in standard care is performed under general anaesthesia * Persons held in an institution by legal or official order * Dysregulated glaucoma with IOP \> 25 mmHg at baseline despite local therapy (Protocol V04\_0 Page 43)

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Augenklinik des Klinikums der Universität München München Bavaria Recruiting
University Hospital of Cologne, Centre for Ophthalmology Cologne North Rhine-Westphalia Recruiting
Universitätsklinikum Düsseldorf, Klinik für Augenheilkunde Düsseldorf North Rhine-Westphalia Recruiting
Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde Homburg Saarland Recruiting
Charité - Universitätsmedizin Berlin, Klinik für Augenheilkunde Berlin Germany Recruiting
Universitätsklinikum Freiburg, Klinik für Augenheilkunde Freiburg im Breisgau Germany Recruiting
Klinik und Poliklinik für Augenheilkunde - Universitätsmedizin Rostock Rostock Germany Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05870566 on ClinicalTrials.gov ↗ ← All trials in Germany