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Trial record 4 of 4 for:    "autoinflammation, lipodystrophy, and dermatosis syndrome"

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 : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
PolyPhotonix Medical

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

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 : June 2018
Estimated Study Completion Date : June 2018


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




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

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

Other Outcome Measures:
  1. Compliance of wearing the mask [ Time Frame: 48 weeks ]
  2. 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
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.


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

Additional Information:
Responsible Party: PolyPhotonix Medical
ClinicalTrials.gov Identifier: NCT02207712     History of Changes
Other Study ID Numbers: PPX-2014-004
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
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:
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
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents