FANCY: Functional Antigen Matching in Corneal Transplantation
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
|
| Placebo Comparator: Random graft assignment
|
Procedure: Penetrating keratoplasty
Corneal transplantation.
|
Outcome Measures
Primary Outcome Measures
- Time to first endothelial graft rejection. [Mostly within the first six months.]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Predicted waiting time for a 4/6 match lower than 6 months.
Exclusion Criteria:
-
Minority
-
Legal incapacity
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Eye Hospital Freiburg | Freiburg | Baden-Württemberg | Germany | 79106 |
Sponsors and Collaborators
- University Hospital Freiburg
- German Research Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- FR-2008-FANCY