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

Primary Purpose

Macula Edema, Retinal Vein Occlusion

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Ellex Integre NIR laser
Sponsored by
University of Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macula Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Macular Research Group, Save Sight Institute, The University of SydneyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NIR laser treatment 200mW/cm2 dose

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Reduction in CMT measured by OCT at 5 and 12 weeks from baseline
Mean change in vision from baseline
Percentage of eyes with no central macular edema at 12 weeks
Percentage of eyes that require rescue treatment
Rescue treatment - intravitreal anti-VEGF
Mean time to rescue treatment
If rescue treatment required, mean time till next anti-VEGF using prn regimen review
Mean time to oedema recurrence (defined as needing intravitreal treatment) if macular edema resolves
Changes to deep vascular OCT-Angiography
Fundus Fluorescein Angiography assessment of leak and capillary closure before (at baseline) and at 12 weeks post baseline after intervention

Full Information

First Posted
April 13, 2021
Last Updated
April 13, 2021
Sponsor
University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT04847869
Brief Title
Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema
Acronym
NIRVO
Official Title
Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sydney

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macula Edema, Retinal Vein Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
7 eyes with branch retinal vein occlusion, 7 with central retinal vein occlusion
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIR laser treatment 200mW/cm2 dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ellex Integre NIR laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Reduction in CMT measured by OCT at 5 and 12 weeks from baseline
Time Frame
5 & 12 weeks
Title
Mean change in vision from baseline
Time Frame
12 weeks
Title
Percentage of eyes with no central macular edema at 12 weeks
Time Frame
12 weeks
Title
Percentage of eyes that require rescue treatment
Description
Rescue treatment - intravitreal anti-VEGF
Time Frame
baseline to 12 weeks
Title
Mean time to rescue treatment
Time Frame
Upto 12 weeks
Title
If rescue treatment required, mean time till next anti-VEGF using prn regimen review
Time Frame
6 months
Title
Mean time to oedema recurrence (defined as needing intravitreal treatment) if macular edema resolves
Time Frame
6 months
Title
Changes to deep vascular OCT-Angiography
Time Frame
12 weeks
Title
Fundus Fluorescein Angiography assessment of leak and capillary closure before (at baseline) and at 12 weeks post baseline after intervention
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Cornish, MBBS PhD
Phone
92837111
Email
elisa.cornish@sydney.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Groeneveld
Phone
0412338075
Email
thomas.groeneveld@sydney.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa E Cornish, MBBS PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Macular Research Group, Save Sight Institute, The University of Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Williams
Phone
93827111
Email
maria.williams@sydney.edu.au

12. IPD Sharing Statement

Plan to Share IPD
No

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

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