NCT02181400: NIRD

Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema

Completed NA Results posted Last updated 7 February 2020

What this trial tests

NA trial testing Ellex Integre NIR laser in Diabetic Macular Oedema in 21 participants. Completed in 15 February 2019.

Timeline

19 April 2016

Primary endpoint
15 February 2019

15 February 2019

Quick facts

Lead sponsor	University of Sydney
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	21
Start date	19 April 2016
Primary completion	15 February 2019
Estimated completion	15 February 2019
Sites	1 location across Australia

Drugs / interventions tested

• Ellex Integre NIR laser

Conditions studied

• Diabetic Macular Oedema — all drugs for Diabetic Macular Oedema →

Sponsor

University of Sydney

Who can join

18 and older, any sex, with Diabetic Macular Oedema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography( OCT) at One Month Primary · Change from baseline in central macular thickness at one month

Change in measurement( in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography( OCT)

Group	Value	95% CI
NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	-25.2	± 35.1
NIR Laser Treatment 100mW/cm2 Dose	-29.9	± 38.6
NIR Laser Treatment 200mW/cm2 Dose	-58.9	± 45.5

Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography (OCT) at Two Months Primary · Change from baseline central macular thickness at two months

Change in measurement (in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography (OCT)

Group	Value	95% CI
NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	-52.5	± 23.6
NIR Laser Treatment 100mW/cm2 Dose	-128.6	± 51.4
NIR Laser Treatment 200mW/cm2 Dose	-114	± 59.5

Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at One Month. Primary · Change from baseline total macular volume at one month

The change in total macular volume was taken as the difference between the total macular volume as measured by Spectral Domain Optical Coherence Tomography at 1 month and the total macular volume at baseline

Group	Value	95% CI
NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	0.1	± 0.4
NIR Laser Treatment 100mW/cm2 Dose	0	± 0.1
NIR Laser Treatment 200mW/cm2 Dose	-0.3	± 0.4

Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at Two Months. Primary · Change from baseline total macular volume as measured by OCT at two months

The change in total macular volume was taken as the difference between the total macular volume as measured by Spectral Domain Optical Coherence Tomography at 2 month and the total macular volume at baseline

Group	Value	95% CI
NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	-0.2	± 0.1
NIR Laser Treatment 100mW/cm2 Dose	0.2	± 0.7
NIR Laser Treatment 200mW/cm2 Dose	-0.2	± 1.2

Change in Logmar Best Corrected Visual Acuity (BCVA) at One Month. Secondary · Change from baseline BCVA measured at one month

Change in Logmar Best corrected visual acuity (BCVA) from 1 month to that measured at baseline

Group	Value	95% CI
NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	4	± 2.0
NIR Laser Treatment 100mW/cm2 Dose	2	± 4
NIR Laser Treatment 200mW/cm2 Dose	6	± 13

Change in Logmar Best Corrected Visual Acuity (BCVA) at Two Months Secondary · Change from baseline BCVA measured at two months

Change in Logmar Best corrected visual acuity (BCVA) from 2 month to that measured at baseline

Group	Value	95% CI
NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	4	± 6
NIR Laser Treatment 100mW/cm2 Dose	-2	± 7
NIR Laser Treatment 200mW/cm2 Dose	-3	± 9.5

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs and SAEs ocular and non-ocular were reported for the whole period in which the participant was in the trial. 16 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose

Serious: 0/7 (0%)

Deaths: 0/7

NIR Laser Treatment 100mW/cm2 Dose

Serious: 0/7 (0%)

Deaths: 0/7

NIR Laser Treatment 200mW/cm2 Dose

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (1 terms — click to expand)

Reaction	System	NIR Laser Treatment 25 Mii…	NIR Laser Treatment 100mW/…	NIR Laser Treatment 200mW/…
Unrelated to study treatment systemic adverse events	General disorders	—	—	—

Data from ClinicalTrials.gov NCT02181400 adverse events section.

Sponsor's own description

This pilot study aims to establish that treatment with near infrared light (NIR) reduces diabetic macular oedema in patients suffering diabetic retinopathy by exerting a positive beneficial effect at retinal cellular level.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preclinical and clinical studies of photobiomodulation therapy for macular oedema.
   Shen W, Teo KYC, Wood JPM, Vaze A, et al · · 2020 · cited 30× · PMID 32661752 · DOI 10.1007/s00125-020-05189-2
2. Photobiomodulation Therapy for Age-Related Macular Degeneration and Diabetic Retinopathy: A Review.
   Muste JC, Russell MW, Singh RP. · · 2021 · cited 21× · PMID 34511875 · DOI 10.2147/opth.s272327
3. Photobiomodulation in 3D tissue engineering.
   Bikmulina P, Kosheleva N, Shpichka A, Yusupov V, et al · · 2022 · cited 13× · PMID 36104833 · DOI 10.1117/1.jbo.27.9.090901