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Noctura400 Treatment for Diabetic Retinopathy (CANDLE)

NCT02207712 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2023-08-14

No results posted yet for this study

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.

Conditions

  • Diabetic Macular Oedema

Interventions

DEVICE

Noctura 400 Eye Mask

The intervention is the wearing of the eye mask

DRUG

Ranibizumab

Standard ranibizumab treatment only

Sponsors & Collaborators

  • PolyPhotonix Medical

    lead INDUSTRY

Principal Investigators

  • Martin Holland · PolyPhotonix Medical

  • Ulrich Meyer-Bothling · Ashford & St Peters Hospitals NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02207712 on ClinicalTrials.gov