Noctura400 Treatment for Diabetic Retinopathy (CANDLE) (CANDLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02207712

Recruitment Status : Active, not recruiting

First Posted : August 4, 2014

Last Update Posted : April 4, 2019

Sponsor:

Information provided by (Responsible Party):

PolyPhotonix Medical

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetic Macular Oedema	Device: Noctura 400 Eye Mask Drug: Ranibizumab	Not Applicable

Show detailed description

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 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 year on year. This is putting immense strain on the resources and budgets of the healthcare system.

In this trial the investigators will explore the health and economic impact of a new, novel therapy for DMO provided by the Noctura 400 Light Mask. The Light Mask provides a non-invasive, light therapy that can be administered at home by the patients themselves. If successful, the introduction of Noctura 400 Light Mask treatment could bring significant benefits to both patients and the healthcare system.

This trial has been designed as a randomised control trial to allow the direct assessment of the Noctura 400 treatment based on a comparison with a control arm of patients not receiving this treatment. All participants in the trial will be due to undergo their first year of a course of intravitreal injection of an anti-VEGF drug known as ranibizumab. Those in the treatment arm will, in addition to this course of injections, wear the Noctura 400 Light Mask each night for 48 weeks. Those in the standard, or control, arm will receive their course of injections only.

The study will involve 240 participants who have been diagnosed with clinically significant DMO and referred to the Hospital Eye Service (HES) for injections. The current threshold for referral is central retinal thickening of 400um or greater. Once in the HES, potential participants will be assessed for eligibility in clinic. These eligibility tests will form the future participant's "baseline visit". If eligible, patients will be invited to participate in the study. The eligibility assessment requires no further tests to those required by the routine care pathway.

After gaining informed consent, eligible and consenting participants will then be randomised into either the intervention arm (those wearing the Noctura 400 Light Mask each night in conjunction with their routine injections) or a standard arm (those receiving their injections only) and will then be invited back to clinic to begin their allocated therapy.

At the first trial visit, those in the intervention arm will be given the Noctura 400 Light Mask to take away with them and instructed how to use it. The Noctura 400 is powered and programmed to last for precisely 12 weeks. Participants will be provided with a replacement mask at appropriate appointments to ensure continuous treatment.

At each and every appointment all participants will undergo Optical Coherence Tomography (OCT) measurements (for assessment of disease progression) and visual acuity (VA) tests. For the first three visits all participants will be given intravitreal injections, following this, participants in both arms will be given injections at appointments only if required based on the results of the OCT and VA tests. Medical history, concomitant medications and adverse events will be recorded at each visit. At weeks 0,12 and 48 patients will fill out insomnia and sleepiness and quality of life questionnaires.

The Noctura 400 has the ability to sense and record when it has been used as a direct measure of compliance. Sleep Mask data will be collected at weeks 12,24,26 and 48. If compliance is low this will be discussed with the participant with the aim of increasing compliance. If at any point during the trial the Noctura 400 Light Mask appears faulty it will be returned for analysis and replaced.

The trial ends at the patient's last visit after 48 weeks of use. Participants will return their Noctura 400 Light Masks for analysis and then patients in both arms are free to continue their routine injections as prescribed by the current care pathway. Participants will be made aware at the time of consenting that the Noctura 400 Light Mask will not be available within the NHS at the end of the trial, but that the manufacturer intends for the device to be available to purchase privately

Study Design

Layout table for study information

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 :	January 2020
Estimated Study Completion Date :	January 2020

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Nakajo-Nishimura syndrome

MedlinePlus related topics: Diabetic Eye Problems Edema Retinal Disorders

Drug Information available for: Ranibizumab

Genetic and Rare Diseases Information Center resources: CANDLE Syndrome JMP Syndrome Nakajo Nishimura Syndrome Nakajo Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Standard Arm Those receiving only their prescribed ranibizumab treatment only	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.	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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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 ]

Other Outcome Measures:

Compliance of wearing the mask [ Time Frame: 48 weeks ]
Changes in sleep pattern. [ Time Frame: 48 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

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

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

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

Locations

Show 18 study locations

Layout table for location information

United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, Berkshire, United Kingdom, RG1 5AN
Hitchingbrooke Healthcare NHS Trust
Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT
Peterborough and Stamford Hospitals NHS Foundation Trust
Peterborough, Cambridgeshire, United Kingdom, PE3 9GZ
South Tees Hospitals NHS Foundation Trust
Middlesbrough, Cleveland, United Kingdom, TS4 3BW
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, United Kingdom, TR1 3LJ
Colchester Hospital University NHS Foundation Trust
Colchester, Essex, United Kingdom, CO4 5JL
Glouchestershire Hospitals NHS Foundation Trust
Cheltenham, Glouchestershire, United Kingdom, GL53 7AG
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom, RG24 9NA
North Lincolnshire and Goole NHS Trust
Scunthorpe, Lincolnshire, United Kingdom, DN15 7BH
James Paget University Hospital NHS Foundation Trust
Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
Norfolk and Norwich University Hospitals NHS Foundation Trust
Colney, Norwich Norfolk, United Kingdom, NR4 7UY
Oxford Radcliffe Hospitals NHS Trust
Headington, Oxford Oxfordshire, United Kingdom, 0X3 9DU
Yeovil District Hospital NHS Foundation Trust
Yeovil, Somerset, United Kingdom, BA21 4AT
Ashford & St Peters Hospitals NHS Foundation Trust
Chertsey, Surrey, United Kingdom, KT16 0PZ
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 7XX
Mid Yorkshire Hospitals NHS Trust
Wakefield, West Yorkshire, United Kingdom, WF1 4EE
Great Western Hospital
Swindon, Wiltshire, United Kingdom, SN3 6BB
Plymouth Hospitals NHS Trust
Plymouth, United Kingdom, PL6 8DH

Sponsors and Collaborators

PolyPhotonix Medical

Investigators

Layout table for investigator information

Study Chair:	Martin Holland	PolyPhotonix Medical
Principal Investigator:	Ulrich Meyer-Bothling	Ashford & St Peters Hospitals NHS Trust

More Information

Additional Information:

Sponsor Website This link exits the ClinicalTrials.gov site

Layout table for additonal information

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 4, 2019
Last Verified:	April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by PolyPhotonix Medical:


Diabetes Macular Oedema Diabetic retinopathy Noctura

Additional relevant MeSH terms:

Layout table for MeSH terms

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

To Top