CANDLE (Noctura400 for DMO)
Research type
Research Study
Full title
Noctura 400 treatment for Diabetic Retinopathy: Pilot study to demonstrate and evaluate the care pathway for NHS adoption. (CANDLE)
IRAS ID
156367
Contact name
Ulrich Meyer-Bothling
Contact email
Sponsor organisation
PolyPhotonix Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 30 days
Research summary
This trial will explore the health and economic impact of a novel therapy for Diabetic Retinopathy (DR) and Diabetic Macular Oedema (DMO) provided by the Noctura 400 Light Mask.
With global diabetes on the rise DMO is now the most common cause of registerable blindness in the working age-group in the UK. Treatment is currently only available when DMO becomes clinically significant at which point a patient can either receive laser photocoagulation therapy or intravitreal injections of inhibitors of Vascular Endothelial Growth Factor (VEGF). Both these options are costly and cause significant burden to the patient, their caregivers and the healthcare system. The Noctura 400 Light Mask provides a non-invasive, light treatment for this condition that can be administered at home by the patients themselves. If successful, the introduction of the Noctura 400 Light Mask treatment could bring significant benefits to both patients and the healthcare system.
The Noctura 400 Light Mask is a mask worn over the patient’s eyes each night as they sleep. The mask contains light sources which bathe the patient’s retina in a precise dose of a light through their closed eyelids. The intensity and spectrum of light has been designed to minimise the disturbance to the patient while providing the required therapeutic dose.
This trial will involve 240 patients that are due to commence a course of anti-VEGF injections for DMO. The patients will be randomly allocated into either an intervention arm (those wearing the Noctura 400 Light Mask in conjunction with their routine injections) or a standard arm (those receiving their injections only). Each group will be followed through 48 weeks of treatment in order to find out if those in the treatment arm required fewer intravitrial injections, analyse the potential cost savings to the NHS and assess the quality of life improvements to the patients.
REC name
London - Chelsea Research Ethics Committee
REC reference
14/LO/1539
Date of REC Opinion
2 Sep 2014
REC opinion
Further Information Favourable Opinion