Improving corneal transplant success with pre-treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of corneal crosslinking as a pre-treatment to enhance graft survival in patients undergoing high-risk corneal transplantation. It is a multicenter, controlled, open randomized parallel-group study comparing outcomes between patients receiving corneal crosslinking and those who do not prior to their transplant. Eligible participants will undergo a series of assessments, including visual acuity and corneal imaging, before and after the intervention. The aim is to reduce pathological neovascularization in the cornea before transplantation.

Why it matters

Who can join: the full rules

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)

Where it's running

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

Study contacts

• Principal investigator: Claus Cursiefen, Prof. Dr. — University Hospital of Cologne, Centre for Ophthalmology
• Study coordinator: Claus Cursiefen, Prof. Dr.
• Email: marie.seifert@uk-koeln.de
• Phone: 00492214784300

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.