Functional Antigen Matching in Corneal Transplantation

Corneal Diseases Clinical Trial

— FANCY  

Official title:

Clinical Trial to Investigate Superiority of HLA Matching in Comparison to Random Graft Assignment With Respect to the Endpoint 'Time to First Endothelial Graft Rejection' in Penetrating Keratoplasty.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810472
• Other study ID #: FR-2008-FANCY
• Status: Completed
• Phase: N/A
• First received: December 17, 2008
• Last updated: October 24, 2016
• Start date: September 2009
• Est. completion date: May 2015

Study information

• Verified date: October 2016
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Penetrating keratoplasty is one of the most commonly performed transplantation surgeries. Graft rejection is a major complication. HLA compatibility has already been demonstrated an effective prophylaxis in several retrospective investigations. The purpose of the investigators randomized clinical trial is to demonstrate superiority of HLA matching in comparison to random graft assignment with respect to the endpoint 'time to first endothelial graft rejection' in penetrating keratoplasty. The investigators will perform DNA-based allele resolution typing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Predicted waiting time for a 4/6 match lower than 6 months.

Exclusion Criteria:

• Minority

• Legal incapacity

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Corneal Diseases

Intervention

Other:
• HLA Matching
HLA matching is exerted by selecting the donor with least-most additional HLA alleles. We will predict the waiting time for such a donor in order to assess eligibility for the trial [8]. In addition, we will dynamically adopt the degree of matching that is aimed at depending on the predicted time interval and actual waiting time: the first donors not exerting more than 7 mismatches at the triplet-amino-acid-residue-level (HLAMatchmaker method [6]) is accepted if the patient is waiting less than half of his predicted waiting time. The next available donor exerting a 2/6 match (or better) is assigned thereafter. The next graft will be assigned, regardless of HLA matching after 6 months.

Procedure:
• Penetrating keratoplasty
Corneal transplantation.

Locations

Country	Name	City	State
Germany	University Eye Hospital Freiburg	Freiburg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Freiburg	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Böhringer D, Reinhard T, Duquesnoy RJ, Böhringer S, Enczmann J, Lange P, Claas F, Sundmacher R. Beneficial effect of matching at the HLA-A and -B amino-acid triplet level on rejection-free clear graft survival in penetrating keratoplasty. Transplantation. 2004 Feb 15;77(3):417-21. — View Citation

Böhringer D, Reinhard T, Enczmann J, Godehard E, Sundmacher R. Individual analysis of expected time on the waiting list for HLA-matched corneal grafts. Dev Ophthalmol. 2003;36:50-5. — View Citation

Böhringer D, Spierings E, Enczmann J, Böhringer S, Sundmacher R, Goulmy E, Reinhard T. Matching of the minor histocompatibility antigen HLA-A1/H-Y may improve prognosis in corneal transplantation. Transplantation. 2006 Oct 27;82(8):1037-41. — View Citation

Reinhard T, Böhringer D, Enczmann J, Kögler G, Mayweg S, Wernet P, Sundmacher R. Improvement of graft prognosis in penetrating normal-risk keratoplasty by HLA class I and II matching. Eye (Lond). 2004 Mar;18(3):269-77. — View Citation

Reinhard T, Böhringer D, Enczmann J, Kögler G, Wernet P, Böhringer S, Sundmacher R. HLA class I/II matching and chronic endothelial cell loss in penetrating normal risk keratoplasty. Acta Ophthalmol Scand. 2004 Feb;82(1):13-8. — View Citation

Reinhard T, Spelsberg H, Henke L, Kontopoulos T, Enczmann J, Wernet P, Berschick P, Sundmacher R, Böhringer D. Long-term results of allogeneic penetrating limbo-keratoplasty in total limbal stem cell deficiency. Ophthalmology. 2004 Apr;111(4):775-82. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first endothelial graft rejection.		Mostly within the first six months.	No