Status:
UNKNOWN
Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema
Lead Sponsor:
University of Sydney
Conditions:
Macula Edema
Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
NA
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 occlusion...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04847869
Start Date
January 1 2021
End Date
July 31 2022
Last Update
April 19 2021
Active Locations (1)
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1
Macular Research Group, Save Sight Institute, The University of Sydney
Sydney, New South Wales, Australia, 2000