Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema

NCT ID: NCT04847869

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-07-31

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.

Conditions

Macula Edema; Retinal Vein Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NIR laser treatment 200mW/cm2 dose

Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.

The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period.

Group Type: EXPERIMENTAL

Ellex Integre NIR laser

Intervention Type: DEVICE

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.

Interventions

Ellex 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sydney

OTHER

Sponsor Role: lead

Responsible Party

Elisa Cornish

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisa E Cornish, MBBS PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Locations

Macular Research Group, Save Sight Institute, The University of Sydney

Sydney, New South Wales, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Dr Cornish, MBBS PhD

Role: CONTACT

elisa.cornish@sydney.edu.au

92837111

Thomas Groeneveld

Role: CONTACT

thomas.groeneveld@sydney.edu.au

0412338075

Facility Contacts

Maria Williams

Role: primary

maria.williams@sydney.edu.au

93827111

References

Romano F, Lamanna F, Gabrielle PH, Teo KYC, Battaglia Parodi M, Iacono P, Fraser-Bell S, Cornish EE, Nassisi M, Viola F, Agarwal A, Samanta A, Chhablani J, Staurenghi G, Invernizzi A. Update on Retinal Vein Occlusion. Asia Pac J Ophthalmol (Phila). 2023 Mar-Apr 01;12(2):196-210. doi: 10.1097/APO.0000000000000598. Epub 2023 Feb 14.

Reference Type: DERIVED

PMID: 36912792 (View on PubMed)

Other Identifiers

NIRVO

Identifier Type: -

Identifier Source: org_study_id