Clinical Trial: Noctura400 Treatment for Diabetic Retinopathy (CANDLE)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Noctura400 Treatment for Diabetic Retinopathy: Pilot Study to Demonstrate and Evaluate the Care Pathway for National Health Service (NHS) Adoption

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 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.


Detailed Summary:

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 people who have diabetes with a growth rate exceeding 150,000 people per year. Diabetic Retinopathy (DR) is the most common complication of diabetes, and the most common cause of sight threatening retinopathy is Diabetic Macular Oedema (DMO).

This condition is characterised by leakage of fluid from compromised blood vessels in the central retina and 240,000 (8%) people with diabetes in the UK have clinically significant DMO, and 100,000 people with DMO have visual impairment. DMO is the most common cause of registerable blindness in the working age-group in the UK. The Diabetic Eye Screening Programme (DESP) annually photographs 3 million people with diabetes at a cost of £65 million to ensure early diagnosis of these sight threatening complications. All patients with diabetic maculopathy are referred to the Hospital Eye Service (HES).

Clinically significant macular oedema requires treatment. Non-central oedema is usually kept under close monitoring or laser treatment is advocated. Centre involving macular oedema is usually treated with intravitreal injections of inhibitors of Vascular Endothelial Growth Factor (anti-VEGF). Whilst laser treatment can reduce the risk of moderate visual loss by 50%, it is not effective in restoring best corrected visual acuity (BCVA) and has significant, quality of life impacting side effects. The anti-VEGF treatments are costly and cause significant burden to patients, their care-givers and the healthcare system.

A patient with DR never leaves the HES. With diabetes on the rise the cost of care for this ever increasing population is growing y
Sponsor: PolyPhotonix Medical

Current Primary Outcome: The number of intravitreal injections of ranibizumab required by each study eye at 48 weeks [ Time Frame: 48 Weeks ]

Original Primary Outcome: The mean difference between trial arms in the number of intravitreal injections of ranibizumab required by each study eye at 48 weeks [ Time Frame: 48 Weeks ]

Current Secondary Outcome:

  • Mean difference from baseline Central sub-field thickness at 48 Weeks [ Time Frame: 48 Weeks ]
  • Mean difference from baseline visual acuity at 48 weeks. [ Time Frame: 48 Weeks ]
  • Mean difference in utility (quality of life). [ Time Frame: Baseline, 12 and 48 weeks ]
  • Difference in the number of ranibizumab injections received by patients who have received at least three injections. [ Time Frame: Between weeks 12 and 48 ]
  • Change in Central sub-field thickness over time [ Time Frame: 12, 24,36 and 48 Weeks ]
  • Pattern of injections given over the period of 48 weeks in both arms. [ Time Frame: 48 weeks ]
  • Adverse events rates [ Time Frame: 48 months ]


Original Secondary Outcome:

  • Mean difference between treatment arms in change from baseline Central sub-field thickness at 48 Weeks [ Time Frame: 48 Weeks ]
  • Mean difference between treatment arms in change from baseline best corrected visual acuity at 48 weeks. [ Time Frame: 48 Weeks ]
  • Mean difference between treatment arms in utility (quality of life) as assessed by EQ-5D. [ Time Frame: Baseline, 12 and 48 weeks ]
  • Mean difference between treatment arms in the number of ranibizumab injections required [ Time Frame: Between weeks 12 and 48 ]
  • Change in Central sub-field thickness over time [ Time Frame: 12, 24,36 and 48 Weeks ]
  • Pattern of injections given over the period of 48 weeks in both arms. [ Time Frame: 48 weeks ]
  • Adverse events rates [ Time Frame: 48 months ]


Information By: PolyPhotonix Medical

Dates:
Date Received: July 24, 2014
Date Started: November 2014
Date Completion: June 2018
Last Updated: October 5, 2016
Last Verified: October 2016