NCT02207712

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

18 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

8.8 years

First QC Date

July 24, 2014

Last Update Submit

August 9, 2023

Conditions

Diabetic Macular Oedema

Keywords

DiabetesMacular OedemaDiabetic retinopathyNoctura

Outcome Measures

Primary Outcomes (1)

  • The number of intravitreal injections of ranibizumab required by each study eye at 48 weeks

    48 Weeks

Secondary Outcomes (7)

  • Mean difference from baseline Central sub-field thickness at 48 Weeks

    48 Weeks

  • Mean difference from baseline visual acuity at 48 weeks.

    48 Weeks

  • Mean difference in utility (quality of life).

    Baseline, 12 and 48 weeks

  • Difference in the number of ranibizumab injections received by patients who have received at least three injections.

    Between weeks 12 and 48

  • Change in Central sub-field thickness over time

    12, 24,36 and 48 Weeks

  • +2 more secondary outcomes

Other Outcomes (2)

  • Compliance of wearing the mask

    48 weeks

  • Changes in sleep pattern.

    48 months

Study Arms (2)

Standard Arm

ACTIVE COMPARATOR

Those receiving only their prescribed ranibizumab treatment only

Drug: Ranibizumab

Intervention Arm

EXPERIMENTAL

Noctura 400 Eye Mask in conjunction with their prescribed ranibizumab treatment.

Device: Noctura 400 Eye MaskDrug: Ranibizumab

Interventions

Noctura 400 Eye MaskDEVICE

The intervention is the wearing of the eye mask

Also known as: Noctura400
Intervention Arm
RanibizumabDRUG

Standard ranibizumab treatment only

Also known as: Those receiving their standard ranibizumab treatment only
Intervention ArmStandard Arm

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Royal Berkshire NHS Foundation Trust

Reading, Berkshire, RG1 5AN, United Kingdom

Location

Hitchingbrooke Healthcare NHS Trust

Huntingdon, Cambridgeshire, PE29 6NT, United Kingdom

Location

Peterborough and Stamford Hospitals NHS Foundation Trust

Peterborough, Cambridgeshire, PE3 9GZ, United Kingdom

Location

South Tees Hospitals NHS Foundation Trust

Middlesbrough, Cleveland, TS4 3BW, United Kingdom

Location

Royal Cornwall Hospitals NHS Trust

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

Colchester Hospital University NHS Foundation Trust

Colchester, Essex, CO4 5JL, United Kingdom

Location

Glouchestershire Hospitals NHS Foundation Trust

Cheltenham, Glouchestershire, GL53 7AG, United Kingdom

Location

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, Hampshire, RG24 9NA, United Kingdom

Location

North Lincolnshire and Goole NHS Trust

Scunthorpe, Lincolnshire, DN15 7BH, United Kingdom

Location

James Paget University Hospital NHS Foundation Trust

Great Yarmouth, Norfolk, NR31 6LA, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Colney, Norwich Norfolk, NR4 7UY, United Kingdom

Location

Oxford Radcliffe Hospitals NHS Trust

Headington, Oxford Oxfordshire, 0X3 9DU, United Kingdom

Location

Yeovil District Hospital NHS Foundation Trust

Yeovil, Somerset, BA21 4AT, United Kingdom

Location

Ashford & St Peters Hospitals NHS Foundation Trust

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Mid Yorkshire Hospitals NHS Trust

Wakefield, West Yorkshire, WF1 4EE, United Kingdom

Location

Great Western Hospital

Swindon, Wiltshire, SN3 6BB, United Kingdom

Location

Plymouth Hospitals NHS Trust

Plymouth, PL6 8DH, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusMacular EdemaDiabetic Retinopathy

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMacular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Martin Holland

    PolyPhotonix Medical

    STUDY CHAIR

  • Ulrich Meyer-Bothling

    Ashford & St Peters Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2014

First Posted

August 4, 2014

Study Start

November 1, 2014

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(18)