Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema
Australia14 participantsStarted 2021-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)