Noctura400 Treatment for Diabetic Retinopathy (CANDLE)
Status:
Active, not recruiting
Trial end date:
2020-07-01
Target enrollment:
Participant gender:
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 halt the progression of centre-involving Diabetic Macular Oedema (DMO). DMO
is a devastating disease that is the most common cause of registerable blindness in the
working age-group in the United Kingdom (UK)
This is a multi-centred randomised controlled trial involving 240 patients. Post
randomization, participants in the intervention arm will wear the Noctura 400 Light Mask at
night for 48 weeks in conjunction with their routine, prescribed treatment of intravitreal
(eye) ranibizumab. Those in the standard arm will receive their routine, prescribed
ranibizumab treatment only.
The primary objective is to determine whether utilizing the Noctura 400 Light Mask at night
reduces the number of intravitreal injections of ranibizumab required by patients undergoing
such a course for the treatment of DMO.