Noctura400 Treatment for Diabetic Retinopathy (CANDLE) (CANDLE)
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ClinicalTrials.gov Identifier: NCT02207712 |
Recruitment Status :
Active, not recruiting
First Posted : August 4, 2014
Last Update Posted : April 26, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Macular Oedema | Device: Noctura 400 Eye Mask Drug: Ranibizumab | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 252 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Noctura400 Treatment for Diabetic Retinopathy: Pilot Study to Demonstrate and Evaluate the Care Pathway for National Health Service (NHS) Adoption |
Actual Study Start Date : | November 2014 |
Estimated Primary Completion Date : | September 2022 |
Estimated Study Completion Date : | September 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Standard Arm
Those receiving only their prescribed ranibizumab treatment only
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Drug: Ranibizumab
Standard ranibizumab treatment only
Other Name: Those receiving their standard ranibizumab treatment only |
Experimental: Intervention Arm
Noctura 400 Eye Mask in conjunction with their prescribed ranibizumab treatment.
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Device: Noctura 400 Eye Mask
The intervention is the wearing of the eye mask
Other Name: Noctura400 Drug: Ranibizumab Standard ranibizumab treatment only
Other Name: Those receiving their standard ranibizumab treatment only |
- The number of intravitreal injections of ranibizumab required by each study eye at 48 weeks [ Time Frame: 48 Weeks ]
- 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 ]
- Compliance of wearing the mask [ Time Frame: 48 weeks ]
- Changes in sleep pattern. [ Time Frame: 48 months ]

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207712

Study Chair: | Martin Holland | PolyPhotonix Medical | |
Principal Investigator: | Ulrich Meyer-Bothling | Ashford & St Peters Hospitals NHS Trust |
Responsible Party: | PolyPhotonix Medical |
ClinicalTrials.gov Identifier: | NCT02207712 |
Other Study ID Numbers: |
PPX-2014-004 |
First Posted: | August 4, 2014 Key Record Dates |
Last Update Posted: | April 26, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Diabetes Macular Oedema Diabetic retinopathy Noctura |
Macular Edema Retinal Diseases Diabetic Retinopathy Macular Degeneration Retinal Degeneration Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications |
Diabetes Mellitus Endocrine System Diseases Ranibizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |