Trials Sponsors Conditions Drugs Pricing

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

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:

Sponsors & Collaborators

PolyPhotonix Medical
Industrylead

Study Sites (18)

Royal Berkshire NHS Foundation Trust

Reading, Berkshire, RG1 5AN, United Kingdom

Hitchingbrooke Healthcare NHS Trust

Huntingdon, Cambridgeshire, PE29 6NT, United Kingdom

Peterborough and Stamford Hospitals NHS Foundation Trust

Peterborough, Cambridgeshire, PE3 9GZ, United Kingdom

South Tees Hospitals NHS Foundation Trust

Middlesbrough, Cleveland, TS4 3BW, United Kingdom

Royal Cornwall Hospitals NHS Trust

Truro, Cornwall, TR1 3LJ, United Kingdom

Colchester Hospital University NHS Foundation Trust

Colchester, Essex, CO4 5JL, United Kingdom

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 Diseases

Study Officials

Martin Holland
PolyPhotonix Medical
STUDY CHAIR
Ulrich Meyer-Bothling
Ashford & St Peters Hospitals NHS Trust
PRINCIPAL INVESTIGATOR

Enrollment

252 participants (actual enrollment reported by the registry).

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 2014

Actual (reported)

Study Stopped

Noctura400 Treatment for Diabetic Retinopathy (CANDLE)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Other Outcomes (2)

Study Arms (2)

Standard Arm

Intervention Arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Other Outcomes (2)

Study Arms (2)

Standard Arm

Intervention Arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations