Noctura400 Treatment for Diabetic Retinopathy (CANDLE)

Conditions

• Diabetic Macular Oedema

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Noctura 400 Eye Mask — DEVICE
  The intervention is the wearing of the eye mask
• Ranibizumab — DRUG
  Standard ranibizumab treatment only

Study Details

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.

Key Dates

First listed

Aug 4, 2014

Start date

Nov 30, 2014

Status verified

Aug 2023

Primary completion

Aug 31, 2023

Completion

Aug 31, 2023

Study Design

Enrollment

252 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard Arm
  Those receiving only their prescribed ranibizumab treatment only
• Experimental: Intervention Arm
  Noctura 400 Eye Mask in conjunction with their prescribed ranibizumab treatment.

Primary Outcome Measure

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