Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/09/2008
Date assigned
06/10/2008
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Armitage

ORCID ID

Contact details

Bristol Eye Hospital
Lower maudlin Street
Bristol
BS1 2LX
United Kingdom
+44 117 34 24585
w.j.armitage@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation of HLA class II histocompatibility matching and cytokine polymorphisms in corneal transplantation

Acronym

CTFS II

Study hypothesis

Primary hypothesis:
HLA class II tissue matching between donors and recipients decreases the risk of cell-mediated rejection in high risk corneal transplants.

Secondary hypothesis:
Cytokine polymorphisms modulate the cell-mediated rejection response in high risk corneal transplants.

Ethics approval

South West Research Ethics Committee:
Original study was approved on 11/12/1997 (ref: MREC/97/6/8)
Study extension was approved on 13/9/2001 (ref: MREC/01/6/77)

Study design

Multicentre, prospective, longitudinal study using cohort minimisation for patient allocation (non-randomised controlled trial)

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Corneal transplantation

Intervention

Patients receive a corneal transplant from a donor matched for HLA class I antigens (not more than two HLA-A and/or HLA-B mismatches combined) with 0, 1 or 2 HLA class II (HLA-DR) mismatches. The level of HLA-DR mismatching defines the study group and is allocated by cohort minimisation. Data are submitted at the time of surgery and the patients are followed up at 6 months, 1, 2, 3, 4 and 5 years postoperatively. Follow-up data include whether the graft has failed, occurrence of rejection episodes, postoperative interventions and medication (including topical steroids and systemic immunosuppressives).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Time to first rejection.

Secondary outcome measures

Time to graft failure.

Overall trial start date

01/09/1998

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Patients of any age or sex tissue typed by polymerase chain reaction using sequence-specific primers (PCR-SSP) or PCR using sequence-specific oligonucleotides (PCR-SSO) with corneal disease requiring a corneal transplant and with the following conditions that increase the risk of cell-mediated rejection:
1. Previously failed corneal transplant
2. Vascularised cornea
3. Ocular inflammatory disease
4. Bullous keratopathy consequent to previous ocular surgery

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

1,200

Participant exclusion criteria

Patients requiring corneal transplants where the risk of rejection is low (e.g., keratoconus and Fuchs' endothelial dystrophy) and where there are no known pre-operative risk factors for rejection.

Recruitment start date

01/09/1998

Recruitment end date

31/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Eye Hospital
Bristol
BS1 2LX
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Research and Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
+44 117 928 8676
Red-Office@bristol.ac.uk

Sponsor type

University/education

Website

http://www.bris.ac.uk

Funders

Funder type

Charity

Funder name

Start-up funding: NHS Executive South & West R&D (UK) (ref: R/14/9.96)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Subsequent funding: National Eye Research Centre (UK) (ref: SCIAD036)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/11/2016: No publications found in PubMed, verifying study status with principal investigator.