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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04847869




Registration number
NCT04847869
Ethics application status
Date submitted
13/04/2021
Date registered
19/04/2021
Date last updated
19/04/2021

Titles & IDs
Public title
Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema
Scientific title
Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema
Secondary ID [1] 0 0
NIRVO
Universal Trial Number (UTN)
Trial acronym
NIRVO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macula Edema 0 0
Retinal Vein Occlusion 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Ellex Integre NIR laser

Experimental: NIR laser treatment 200mW/cm2 dose - Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.
The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period.


Treatment: Devices: Ellex Integre NIR laser
The Ellex Integre NIR (near Infrared Light) Laser dose of 200 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in central macular thickness (CMT) measured by optical coherence tomography (OCT) 12 weeks from baseline, in participants with macular edema from a retinal vein occlusion (RVO)
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Reduction in CMT measured by OCT at 5 and 12 weeks from baseline
Timepoint [1] 0 0
5 & 12 weeks
Secondary outcome [2] 0 0
Mean change in vision from baseline
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Percentage of eyes with no central macular edema at 12 weeks
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Percentage of eyes that require rescue treatment
Timepoint [4] 0 0
baseline to 12 weeks
Secondary outcome [5] 0 0
Mean time to rescue treatment
Timepoint [5] 0 0
Upto 12 weeks
Secondary outcome [6] 0 0
If rescue treatment required, mean time till next anti-VEGF using prn regimen review
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Mean time to oedema recurrence (defined as needing intravitreal treatment) if macular edema resolves
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Changes to deep vascular OCT-Angiography
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Fundus Fluorescein Angiography assessment of leak and capillary closure before (at baseline) and at 12 weeks post baseline after intervention
Timepoint [9] 0 0
12 weeks

Eligibility
Key inclusion criteria
- Diagnosis macular edema secondary to branch or central vein occlusion (BRVO or CRVO)

- CMT of >300 µm and less than 550 µm;

- Best corrected visual acuity of 6/6 to 6/24 (letters 87 - 53);

- Intraocular pressure < 25 mmHg;

- Written informed consent has been obtained.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Loss of vision due to other causes (e.g. age-related macular degeneration, myopic
macular degeneration, DME);

- Known allergy to agents used in the study e.g. fluorescein;

- Women who are pregnant, nursing, or planning a pregnancy, or who are of childbearing
potential and not using reliable means of contraception;

- Only eye (vision in other eye <6/60);

- Study eye is an amblyopic eye;

- Macular oedema due to other causes;

- Significant diabetic retinopathy;

- An ocular condition that would prevent visual acuity improvement despite resolution of
oedema (such as foveal atrophy or substantial premacular fibrosis;

- Previous treatment with any anti-VEGF therapy or investigational drugs in the study
eye at any time prior to baseline.

- Previous use of intraocular or periocular steroids in study eye at any time prior to
baseline;

- Cataract surgery within the last 3 months;

- Retinal laser treatment within the last 6 months;

- Media opacity including cataract that already precludes adequate macular photography
or cataract that is likely to require surgery within 6 months;

- Intercurrent severe disease such as septicaemia, any condition which would affect
follow-up;

- History of chronic renal failure requiring dialysis or renal transplant;

- Blood pressure >180/120;

- Participant has a condition or is in a situation that in the investigator's opinion
may put the participant at significant risk, may confound the study results, or may
interfere significantly with the participant's participation in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2022
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macular Research Group, Save Sight Institute, The University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This pilot study aims to establish that treatment with near infrared light (NIR) reduces
cystic macular oedema in patients with a retinal vein occlusion.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04847869
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elisa E Cornish, MBBS PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dr Cornish, MBBS PhD
Address 0 0
Country 0 0
Phone 0 0
92837111
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04847869