Noctura400 Treatment for Diabetic Retinopathy (CANDLE) (CANDLE)
Diabetic Macular Oedema
About this trial
This is an interventional treatment trial for Diabetic Macular Oedema focused on measuring Diabetes, Macular Oedema, Diabetic retinopathy, Noctura
Eligibility Criteria
Inclusion Criteria:
i. Subjects of either sex aged 18 years or over. ii. Diagnosis of diabetes mellitus (type 1 or type 2). iii. Presence of clinically significant centre-involving macular oedema resultant from DR of ≥400µm (CST/CMT as measured by OCT, and is listed for ranibizumab therapy in the study eye.
Exclusion Criteria:
Any potential participant will be excluded if they have:
i. Received any previous anti-VEGF/steroid intravitreal injections in the study eye in the last 6 months.
ii. Presence of proliferative diabetic retinopathy (PDR) at screening.
iii. Significant systemic diseases know to affect visual function, other than diabetes (e.g. Parkinson's disease or Alzheimer's disease).
iv. History of relevant sleeping disorders/insomnia .
v. A condition that would preclude participation in the study.
Sites / Locations
- Royal Berkshire NHS Foundation Trust
- Hitchingbrooke Healthcare NHS Trust
- Peterborough and Stamford Hospitals NHS Foundation Trust
- South Tees Hospitals NHS Foundation Trust
- Royal Cornwall Hospitals NHS Trust
- Colchester Hospital University NHS Foundation Trust
- Glouchestershire Hospitals NHS Foundation Trust
- Basingstoke and North Hampshire NHS Foundation Trust
- North Lincolnshire and Goole NHS Trust
- James Paget University Hospital NHS Foundation Trust
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Oxford Radcliffe Hospitals NHS Trust
- Yeovil District Hospital NHS Foundation Trust
- Ashford & St Peters Hospitals NHS Foundation Trust
- Royal Surrey County Hospital
- Mid Yorkshire Hospitals NHS Trust
- Great Western Hospital
- Plymouth Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard Arm
Intervention Arm
Those receiving only their prescribed ranibizumab treatment only
Noctura 400 Eye Mask in conjunction with their prescribed ranibizumab treatment.