Natural History Study in Diabetic Retinopathy
Research type
Research Study
Full title
A MULTICENTER, PROSPECTIVE, OBSERVATIONAL, LOW-INTERVENTIONAL, NON-DRUG STUDY ON THE PROGRESSION OF ISCHEMIA IN DIABETIC RETINOPATHY
IRAS ID
357678
Contact name
Tunde Peto
Contact email
Sponsor organisation
Roche Products Ltd.
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 12 days
Research summary
Diabetic retinopathy is a condition where high blood sugar levels from diabetes damage the back of the eye. It can cause vision impairment, leading to blindness, if not treated. Approximately 200 people aged 18 years or over from UK, USA, Europe and Asia will take part in this study.
The purpose of this study is to compare the results of routine tests, mainly imaging that patients undergo to monitor diabetic retinopathy and determine which of these are best to measure the progression of diabetic retinopathy.
The duration of study is 100 weeks (approximately 2 years). The study comprises of a screening period for up to 28 days and an observation period during which participants will visit the study site for tests and procedures, most of which may be part of their standard care.
During the study, participants will undergo different imaging tests that check the health of the eye along with some questionnaires that check the vision.
REC name
London - City & East Research Ethics Committee
REC reference
25/PR/1104
Date of REC Opinion
25 Sep 2025
REC opinion
Further Information Favourable Opinion