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

Launched by CLAUS CURSIEFEN · May 21, 2023

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ClinConnect Summary

**Clinical Trial Summary: CrossCornealVision**

The CrossCornealVision clinical trial is looking at a new method to help improve the success of corneal transplants. Specifically, the study is testing a treatment called corneal crosslinking, which is done before the actual transplant surgery. This treatment aims to reduce the growth of abnormal blood vessels in the cornea (the clear front part of the eye) that can make transplants less successful. By addressing these issues beforehand, researchers hope to increase the chances that the new cornea will survive and function well.

To join this study, participants should be at least 18 years old and have a specific eye condition that involves significant abnormal blood vessel growth in at least two quadrants of the cornea. People with certain other medical conditions or those who have had recent eye surgeries may not be eligible. If you decide to participate, you will need to provide written consent and be ready to follow the study procedures. This research is currently recruiting participants of all genders, and it is important for those interested to discuss it with their doctor to see if they might qualify.

Gender

ALL

Eligibility criteria

• 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)