Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema

Retinal Vein Occlusion Clinical Trial

— NIRVO  

Official title:

Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04847869
• Other study ID #: NIRVO
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: April 2021
• Source: University of Sydney
• Contact: Dr Cornish, MBBS PhD
• Phone: 92837111
• Email: elisa.cornish[@]sydney.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Intraocular injections of Vascular Endothelial Growth Factor (VEGF) inhibitors have been shown to improve swelling of central retina (macular oedema) and vision in patients with retinal vein occlusions (RVO), however this treatment comes with potentially sight threatening risks. A less invasive treatment might have many advantages. We recently showed that eyes with macular oedema caused by diabetes, the other main cause of macular oedema, who received treatment with near-infrared (NIR) light was not only safe but was also effective in reducing the swelling. The US Diabetic Retinopathy Research Collaboration are currently recruiting for a larger study of NIR light which may or may not confirm our findings. We propose to test the safety and efficacy of the same NIR light in patients with macular oedema from retinal vein occlusions. We anticipate this may reduce the need for injections of VEGF inhibitors in eyes with RVO, in particular eyes with good vision. This pilot study will help determine whether PBM with NIR for RVO warrants further investigation in a larger study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: July 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Edema
• Macula Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Australia	Macular Research Group, Save Sight Institute, The University of Sydney	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		12 weeks
Secondary	Reduction in CMT measured by OCT at 5 and 12 weeks from baseline		5 & 12 weeks
Secondary	Mean change in vision from baseline		12 weeks
Secondary	Percentage of eyes with no central macular edema at 12 weeks		12 weeks
Secondary	Percentage of eyes that require rescue treatment	Rescue treatment - intravitreal anti-VEGF	baseline to 12 weeks
Secondary	Mean time to rescue treatment		Upto 12 weeks
Secondary	If rescue treatment required, mean time till next anti-VEGF using prn regimen review		6 months
Secondary	Mean time to oedema recurrence (defined as needing intravitreal treatment) if macular edema resolves		6 months
Secondary	Changes to deep vascular OCT-Angiography		12 weeks
Secondary	Fundus Fluorescein Angiography assessment of leak and capillary closure before (at baseline) and at 12 weeks post baseline after intervention		12 weeks