Clinical trial NCT04847869: Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema
Official title: Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macula Edema
Retinal Vein Occlusion
Lead sponsor: University of Sydney
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 7 eyes with branch retinal vein occlusion, 7 with central retinal vein occlusion
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 12 weeks
Secondary outcomes:
measure: Reduction in CMT measured by OCT at 5 and 12 weeks from baseline
timeFrame: 5 & 12 weeks
measure: Mean change in vision from baseline
timeFrame: 12 weeks
measure: Percentage of eyes with no central macular edema at 12 weeks
timeFrame: 12 weeks
measure: Percentage of eyes that require rescue treatment
timeFrame: baseline to 12 weeks
measure: Mean time to rescue treatment
timeFrame: Upto 12 weeks
measure: If rescue treatment required, mean time till next anti-VEGF using prn regimen review
timeFrame: 6 months
measure: Mean time to oedema recurrence (defined as needing intravitreal treatment) if macular edema resolves
timeFrame: 6 months
measure: Changes to deep vascular OCT-Angiography
timeFrame: 12 weeks
measure: Fundus Fluorescein Angiography assessment of leak and capillary closure before (at baseline) and at 12 weeks post baseline after intervention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Macular Research Group, Save Sight Institute, The University of Sydney
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Elisa E Cornish, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References: