This pilot study aims to establish that treatment with near infrared light (NIR) reduces cystic macular oedema in patients with a retinal vein occlusion.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
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.
Macular Research Group, Save Sight Institute, The University of Sydney
Sydney, New South Wales, Australia
RECRUITINGReduction 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)
Time frame: 12 weeks
Reduction in CMT measured by OCT at 5 and 12 weeks from baseline
Time frame: 5 & 12 weeks
Mean change in vision from baseline
Time frame: 12 weeks
Percentage of eyes with no central macular edema at 12 weeks
Time frame: 12 weeks
Percentage of eyes that require rescue treatment
Rescue treatment - intravitreal anti-VEGF
Time frame: baseline to 12 weeks
Mean time to rescue treatment
Time frame: Upto 12 weeks
If rescue treatment required, mean time till next anti-VEGF using prn regimen review
Time frame: 6 months
Mean time to oedema recurrence (defined as needing intravitreal treatment) if macular edema resolves
Time frame: 6 months
Changes to deep vascular OCT-Angiography
Time frame: 12 weeks
Fundus Fluorescein Angiography assessment of leak and capillary closure before (at baseline) and at 12 weeks post baseline after intervention
Time frame: 12 weeks
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