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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 : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
PolyPhotonix Medical

Study Description
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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

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Study Design
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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 : July 2020
Estimated Study Completion Date : July 2020

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Drug Information available for: Ranibizumab

Arms and Interventions
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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
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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 ]

Eligibility Criteria
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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.

Contacts and Locations
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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
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Sponsors and Collaborators
PolyPhotonix Medical
Investigators
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Study Chair: Martin Holland PolyPhotonix Medical
Principal Investigator: Ulrich Meyer-Bothling Ashford & St Peters Hospitals NHS Trust
More Information
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Additional Information:

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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: March 4, 2020
Last Verified: March 2020
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:
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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