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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.
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.
Diabetic retinopathy is a common cause of severe loss of vision and the most common cause of blindness in individuals between the ages of 20 and 65 years in developed countries.Swelling of the central retina or "macular oedema". Patients will be treated in an office clinic,three times a week for a treatment duration of 2 minutes per session, a total of 12 times over the duration of 4 weeks and will be assessed at 8 weeks to establish any change induced in retinal oedema. Safety follow up will be assessed at 3 and 6 months post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIR Laser Treatment 25 miiliwatts (mW)/cm2 dose | Active Comparator | The Ellex Integre NIR (near Infrared Light) Laser dose of 25 milliwats(mW)/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks. |
|
| NIR laser treatment 100mW/cm2 dose | Active Comparator | The Ellex Integre NIR Laser dose of 100 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks. |
|
| NIR laser treatment 200mW/cm2 dose | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ellex Integre NIR laser | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography( OCT) at One Month | Change in measurement( in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography( OCT) | Change from baseline in central macular thickness at one month |
| Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography (OCT) at Two Months | Change in measurement (in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography (OCT) | Change from baseline central macular thickness at two months |
| Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography 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 | Change from baseline total macular volume at one month |
| Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography 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 | Change from baseline total macular volume as measured by OCT at two months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Logmar Best Corrected Visual Acuity (BCVA) at One Month. | Change in Logmar Best corrected visual acuity (BCVA) from 1 month to that measured at baseline | Change from baseline BCVA measured at one month |
| Change in Logmar Best Corrected Visual Acuity (BCVA) at Two Months |
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Inclusion Criteria:
Exclusion Criteria:a) Known allergy to agents used in the study eg. fluorescein b) Women who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using reliable means of contraception. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or is surgically sterilised c) Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion) d) Macular oedema due to other causes e) An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy or substantial premacular fibrosis) f) Treatment with intravitreal triamcinolone acetonide (IVTA) within the last 6 months or peribulbar triamcinolone within the last 3 months, or anti vascular endothelial growth factor (VEGF) drugs: ranibizumab and aflibercept, within the last 2 months.
g) Cataract surgery within the last 3 months h) Retinal laser treatment within the last 4 months i) Media opacity including cataract that already precludes adequate macular photography or cataract that is likely to require surgery within 6 months j) Intercurrent severe disease such as septicaemia, any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social) k) History of chronic renal failure requiring dialysis or renal transplant l) Blood pressure >180/100 m) Patient has a condition or is in a situation that in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
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| Name | Affiliation | Role |
|---|---|---|
| Mark C Gillies, MD PhD | Sydney University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney Eye Hospital | Sydney | New South Wales | 2000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32661752 | Derived | Shen W, Teo KYC, Wood JPM, Vaze A, Chidlow G, Ao J, Lee SR, Yam MX, Cornish EE, Fraser-Bell S, Casson RJ, Gillies MC. Preclinical and clinical studies of photobiomodulation therapy for macular oedema. Diabetologia. 2020 Sep;63(9):1900-1915. doi: 10.1007/s00125-020-05189-2. Epub 2020 Jul 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose | The Ellex Integre NIR (near Infrared Light) Laser dose of 25 milliwats(mW)/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks. Ellex Integre NIR laser: 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. |
| FG001 | NIR Laser Treatment 100mW/cm2 Dose | The Ellex Integre NIR Laser dose of 100 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks. Ellex Integre NIR laser: 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. |
| FG002 | NIR Laser Treatment 200mW/cm2 Dose | 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. Ellex Integre NIR laser: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose | The Ellex Integre NIR (near Infrared Light) Laser dose of 25 milliwats(mW)/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks. Ellex Integre NIR laser: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography( OCT) at One Month | Change in measurement( in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography( OCT) | Posted | Mean | Standard Deviation | micrometers | Change from baseline in central macular thickness at one month |
|
AEs and SAEs ocular and non-ocular were reported for the whole period in which the participant was in the trial. 16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose | The Ellex Integre NIR (near Infrared Light) Laser dose of 25 milliwats(mW)/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks. Ellex Integre NIR laser: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated to study treatment systemic adverse events | General disorders | SNOMED CT | Systematic Assessment | see AE table if needed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Willilams | Sydney Eye Hospital | 02 9382 7309 | maria.williams@sydney.edu.au |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 11, 2017 | Aug 29, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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|
Change in Logmar Best corrected visual acuity (BCVA) from 2 month to that measured at baseline |
| Change from baseline BCVA measured at two months |
| BG001 | NIR Laser Treatment 100mW/cm2 Dose | The Ellex Integre NIR Laser dose of 100 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks. Ellex Integre NIR laser: 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. |
| BG002 | NIR Laser Treatment 200mW/cm2 Dose | 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. Ellex Integre NIR laser: 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Visual Acuity change | Mean | Standard Deviation | letters |
|
| OG001 | NIR Laser Treatment 100mW/cm2 Dose | The Ellex Integre NIR Laser dose of 100 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks. Ellex Integre NIR laser: 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. |
| OG002 | NIR Laser Treatment 200mW/cm2 Dose | 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. Ellex Integre NIR laser: 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. |
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| Primary | Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography (OCT) at Two Months | Change in measurement (in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography (OCT) | Posted | Mean | Standard Deviation | micrometers | Change from baseline central macular thickness at two months |
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|
| Primary | Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography 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 | Posted | Mean | Standard Deviation | millimeter cube | Change from baseline total macular volume at one month |
|
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| Primary | Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography 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 | Posted | Mean | Standard Deviation | millimeters cube | Change from baseline total macular volume as measured by OCT at two months |
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| Secondary | Change in Logmar Best Corrected Visual Acuity (BCVA) at One Month. | Change in Logmar Best corrected visual acuity (BCVA) from 1 month to that measured at baseline | Posted | Mean | Standard Deviation | letters | Change from baseline BCVA measured at one month |
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| Secondary | Change in Logmar Best Corrected Visual Acuity (BCVA) at Two Months | Change in Logmar Best corrected visual acuity (BCVA) from 2 month to that measured at baseline | Posted | Mean | Standard Deviation | letters | Change from baseline BCVA measured at two months |
|
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|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 7 |
| 7 |
| EG001 | NIR Laser Treatment 100mW/cm2 Dose | The Ellex Integre NIR Laser dose of 100 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks. Ellex Integre NIR laser: 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. | 0 | 7 | 0 | 7 | 4 | 7 |
| EG002 | NIR Laser Treatment 200mW/cm2 Dose | 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. Ellex Integre NIR laser: 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. | 0 | 7 | 0 | 7 | 6 | 7 |
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| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|