Macula Edema, Retinal Vein Occlusion
Conditions
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.
Interventions
DEVICEEllex 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.
Sponsors
University of Sydney
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
7 eyes with branch retinal vein occlusion, 7 with central retinal vein occlusion
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | baseline to 12 weeks | Rescue treatment - intravitreal anti-VEGF |
| 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 | — |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORElisa E Cornish, MBBS PhD
University of Sydney
Outcome results
None listed