Macula EdemaNIRVONCT04847869
Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema
A study testing Ellex Integre NIR laser in people with Macula Edema and Retinal Vein Occlusion, run by University of Sydney at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macula Edema, Retinal Vein Occlusion
- What is being tested?
- Ellex Integre NIR laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jan 2021to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Macular Research Group, Save Sight Institute, The University of Sydney
Sydney, New South Wales, 2000
About this study
This pilot study aims to establish that treatment with near infrared light (NIR) reduces cystic macular oedema in patients with a retinal vein occlusion.
Read the 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
- Being tested
- Ellex Integre NIR laser
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ellex Integre NIR laserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ellex Integre NIR laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (9)
Reduction in CMT measured by OCT at 5 and 12 weeks from baseline
Measured: 5 & 12 weeks
Mean change in vision from baseline
Measured: 12 weeks
Percentage of eyes with no central macular edema at 12 weeks
Measured: 12 weeks
Percentage of eyes that require rescue treatment
Rescue treatment - intravitreal anti-VEGF
Measured: baseline to 12 weeks
Mean time to rescue treatment
Measured: Upto 12 weeks
If rescue treatment required, mean time till next anti-VEGF using prn regimen review
Measured: 6 months
Mean time to oedema recurrence (defined as needing intravitreal treatment) if macular edema resolves
Measured: 6 months
Changes to deep vascular OCT-Angiography
Measured: 12 weeks
Fundus Fluorescein Angiography assessment of leak and capillary closure before (at baseline) and at 12 weeks post baseline after intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Jul 2024
Why it stopped: Poor efficacy of treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macula EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 7 eyes with branch retinal vein occlusion, 7 with central retinal vein occlusion
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Cornish, University of Sydney
- Investigators
- Elisa E Cornish, MBBS PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847869
- Sponsor's protocol ID
- NIRVO
- Acronym
- NIRVO
- Status last verified
- Oct 2025
- First submitted
- 13 Apr 2021
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36912792
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema
- ClinicalTrials.gov ID
- NCT04847869
- Acronym / sponsor ID
- NIRVO / NIRVO
- Conditions
- Macula Edema, Retinal Vein Occlusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor efficacy of treatment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 7 eyes with branch retinal vein occlusion, 7 with central retinal vein occlusion
| Arm | Type | Receives |
|---|---|---|
| NIR laser treatment 200mW/cm2 dose | Experimental | Device: Ellex Integre NIR laserEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ellex Integre NIR laserThe 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. | Device | NIR laser treatment 200mW/cm2 dose |
Primary outcome
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
9 secondary outcomes
Reduction in CMT measured by OCT at 5 and 12 weeks from baseline
Time frame: 5 & 12 weeks
Mean change in vision from baseline
Time frame: 12 weeks
Percentage of eyes with no central macular edema at 12 weeks
Time frame: 12 weeks
Percentage of eyes that require rescue treatment
Time frame: baseline to 12 weeks
Mean time to rescue treatment
Time frame: Upto 12 weeks
If rescue treatment required, mean time till next anti-VEGF using prn regimen review
Time frame: 6 months
Mean time to oedema recurrence (defined as needing intravitreal treatment) if macular edema resolves
Time frame: 6 months
Changes to deep vascular OCT-Angiography
Time frame: 12 weeks
Fundus Fluorescein Angiography assessment of leak and capillary closure before (at baseline) and at 12 weeks post baseline after intervention
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Poor efficacy of treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Derived from this study: PubMed 36912792Romano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa E Cornish, MBBS PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ellex Integre NIR laser in people with Macula Edema and Retinal Vein Occlusion, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor efficacy of treatment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.