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

NCT04847869 | Unknown DMC

• 1 other identifier: NIRVO
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Macula Edema; Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (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)

  12 weeks

Secondary Outcomes (9)

• 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

• Mean time to rescue treatment

  Upto 12 weeks

Study Arms (1)

NIR laser treatment 200mW/cm2 dose

EXPERIMENTAL

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.

Device: Ellex Integre NIR laser

Interventions

Ellex Integre NIR laser 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.

NIR laser treatment 200mW/cm2 dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Sydney: lead

Study Sites (1)

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

Sydney, New South Wales, 2000, Australia

RECRUITING

Related Publications (1)

• 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.

  PMID: 36912792 DERIVED

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elisa E Cornish, MBBS PhD

  University of Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Cornish, MBBS PhD

CONTACT

92837111; elisa.cornish@sydney.edu.au

Thomas Groeneveld

CONTACT

0412338075; thomas.groeneveld@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 7 eyes with branch retinal vein occlusion, 7 with central retinal vein occlusion

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: July 31, 2022
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)