Status:
TERMINATED
Noctura400 Treatment for Diabetic Retinopathy (CANDLE)
Lead Sponsor:
PolyPhotonix Medical
Conditions:
Diabetic Macular Oedema
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
In this study, the investigators aim to use light masks (Noctura 400) to test the hypothesis that preventing the dark adaptation and associated hypoxia of the rods in the eye could in turn prevent or ...
Detailed Description
Diabetes is regarded by the World Health Organisation (WHO) as a global epidemic, with the global diabetic population anticipated to exceed 500 million by 2020. In the UK there are over 3.5 million pe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT02207712
Start Date
November 1 2014
End Date
August 1 2023
Last Update
August 14 2023
Active Locations (18)
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1
Royal Berkshire NHS Foundation Trust
Reading, Berkshire, United Kingdom, RG1 5AN
2
Hitchingbrooke Healthcare NHS Trust
Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT
3
Peterborough and Stamford Hospitals NHS Foundation Trust
Peterborough, Cambridgeshire, United Kingdom, PE3 9GZ
4
South Tees Hospitals NHS Foundation Trust
Middlesbrough, Cleveland, United Kingdom, TS4 3BW