Stratifying Retinopathy Risk in Type 1 Diabetes Pilot
Research type
Research Study
Full title
A Single Centre, Non-Intervention, Observational, Predictive Biomarker Pilot Study to Stratify Retinopathy Risk in Patients with Type 1 Diabetes
IRAS ID
252828
Contact name
Richard Lee
Contact email
Sponsor organisation
University College London, Joint Research Office (part of the Research Support Centre)
Clinicaltrials.gov Identifier
Z6364106/2018/11/33, UCL Data verification number
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
Patients will be recruited from the medical retinal clinics of Moorfields Eye Hospital.
The objective of this study is to help advances for patients with the blinding complications of type 1 diabetes (T1D) to get into clinical practice faster and more cost effectively.
The aim is to do this by conducting a pilot study taking blood samples from 60 T1D patients, using a range of cutting-edge scientific technologies which characterize the human immune response.
This is a biomarker discovery proposal in human subjects with T1D. The additional involvement for study participants is more extensive non-invasive imaging of their retinal vasculature than would be usually conducted as part of their regular clinical care, and a research blood draw (15-30ml) which will be taken at the same time as their usual blood tests.
In this case-control biomarker discovery study, 30 T1D patients with sight-threatening proliferative diabetic retinopathy and 30 T1D patients with early non-proliferative disease will be compared in terms of their retinal features and the characteristics of innate immune cells in their peripheral blood.
From this, the study seeks to generate a robust biological signature that predicts the progression of diabetic retinopathy at an individual patient level. If successful, the Sponsor will then seek to validate this in a subsequent largescale multi-centre study prior to wider roll-out for a range of clinical and research applications.
It is anticipated that this pilot single-centre clinical study will generate a candidate biomarker to predict which patients are at high risk of losing vision due to the sight-threatening consequences of their T1D. This biomarker will then need to be validated in a prospective multi-centre study prior to dissemination for the benefit of T1D patients in a range of clinical and research studies.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
19/YH/0042
Date of REC Opinion
15 Feb 2019
REC opinion
Further Information Favourable Opinion