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

This pilot study aims to establish that treatment with near infrared light (NIR) reduces cystic macular oedema in patients with a retinal vein occlusion.

Study Overview

• Status: Recruiting
• Conditions: Retinal Vein Occlusion; Macula Edema
• Intervention / Treatment: Device: Ellex Integre NIR laser

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Cornish, MBBS PhD; Phone Number: 92837111; Email: elisa.cornish@sydney.edu.au
• Study Contact Backup: Name: Thomas Groeneveld; Phone Number: 0412338075; Email: thomas.groeneveld@sydney.edu.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2000
      • Recruiting
      • Macular Research Group, Save Sight Institute, The University of Sydney
      • Contact: Maria Williams; Phone Number: 93827111; Email: maria.williams@sydney.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Sydney
• Investigators: Principal Investigator: Elisa E Cornish, MBBS PhD, University of Sydney

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Edema
• Other Study ID Numbers: NIRVO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No