Human Retinal Leukogram
Research type
Research Study
Full title
A Single-Centre, Non-Randomised, Open-Label, Study to Investigate the Ocular Distribution of Ex Vivo Fluorescein Labelled Autologous Leukocytes in Patients with Uveitis, Diabetic Retinopathy and Age-Related Macular Degeneration
IRAS ID
186744
Contact name
Richard Lee
Contact email
Sponsor organisation
Moorfields Eye Hospital
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is the first study of its kind involving imaging of T-Cells (white blood cells) in patients with inflammatory eye diseases. The study is split into 2 stages. Stage 1 (validation stage) requires completion and approval from a safety committee before proceeding to stage 2 (clinical stage).
Each patient (both stage 1 and stage 2) will undergo a procedure known as apheresis to collect their own white blood cells. Following collection of these cells, the cells are transported to a specialist facility where they will labelled with a visible dye known as sodium fluorescein.
The team at Moorfields Eye Hospital (MEH) have significant experience using sodium fluorescein as this dye is already injected into patients’ as standard clinical practice for the investigation of eye diseases. This study aims to progress this standard approach by staining the cells directly and then imaging them. This is the novelty of this study.
Although the widespread use of this dye provides reassurance that it is safe, the research team want to confirm that their proposed approach does not harmfully activate immune cells. A number of pre-clinical studies have therefore been carried out using blood samples obtained from consenting healthy volunteers. These confirmed the safety of the researchers technique. To further ensure that patients' cells will not be altered by the labeling process, an additional validation phase has been included (Stage 1). For stage 1, up to 3 patients in each disease group will be recruited. Following collection of their white cells, the cells will be transferred to the Cells for Sight Facility at MEH where they will be stained with sodium fluorescein the following day under Good Manufacturing conditions. The cells will be analysed in the laboratory to ensure that this process is safe. The patients recruited to stage 1 of the study will not receive their stained cells back and after 5 days the cells will be discarded. The safety data from stage 1 patients, along with the results from the previous pre-clinical work, will be reviewed by the appointed Independent Data Monitoring Committee before authorisation is given to proceed to Stage 2.
For Stage 2, patients in each disease group will be recruited and again their cells will be collected by apheresis. Following cell collection, the cells will be transferred to the Cells for Sight Facility where they will be prepared and stained using the technique that was confirmed to be safe in Stage 1. The patients then receive their own stained cells back through an intravenous (into the vein) infusion. Comprehensive imaging will then take place to track the labelled T cells as they circulate through the blood vessels at the back of the patients' eyes. We hope the results obtained through this study will be used to optimise imaging techniques, lead to a better understanding of inflammatory eye diseases, and ultimately improve patient care.REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/0550
Date of REC Opinion
7 Jul 2016
REC opinion
Further Information Favourable Opinion