Back to resultsNear Infrared Photobiomodulation Treatment for Diabetic Macular Oedema (NIRD)
Primary Purpose
Diabetic Macular Oedema
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Ellex Integre NIR laser
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Oedema focused on measuring diabetic retinopathy, diabetic macular edema, diabetic macular oedema, near infrared light therapy
Eligibility Criteria
Inclusion Criteria:
- Diabetic Macular Oedema with centre involving thickness of >300µm
- Age >= 18 years
- Diagnosis of diabetes mellitus
- Best corrected visual acuity of 6/9 to 6/60 (letters 77- 33)
- Intraocular pressure 6 to 25 mmHg
- Written informed consent has been obtained.
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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Sites / Locations
- Sydney Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
NIR Laser Treatment 25 miiliwatts (mW)/cm2 dose
NIR laser treatment 100mW/cm2 dose
NIR laser treatment 200mW/cm2 dose
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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 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 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 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
Secondary Outcome Measures
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 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02181400
Brief Title
Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema
Acronym
NIRD
Official Title
Pilot Study of Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 19, 2016 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
February 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sydney
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Oedema
Keywords
diabetic retinopathy, diabetic macular edema, diabetic macular oedema, near infrared light therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NIR Laser Treatment 25 miiliwatts (mW)/cm2 dose
Arm Type
Active Comparator
Arm Description
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.
Arm Title
NIR laser treatment 100mW/cm2 dose
Arm Type
Active Comparator
Arm Description
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.
Arm Title
NIR laser treatment 200mW/cm2 dose
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Ellex Integre NIR laser
Intervention 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.
Primary Outcome Measure Information:
Title
Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography( OCT) at One Month
Description
Change in measurement( in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography( OCT)
Time Frame
Change from baseline in central macular thickness at one month
Title
Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography (OCT) at Two Months
Description
Change in measurement (in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography (OCT)
Time Frame
Change from baseline central macular thickness at two months
Title
Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at One Month.
Description
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
Time Frame
Change from baseline total macular volume at one month
Title
Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at Two Months.
Description
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
Time Frame
Change from baseline total macular volume as measured by OCT at two months
Secondary Outcome Measure Information:
Title
Change in Logmar Best Corrected Visual Acuity (BCVA) at One Month.
Description
Change in Logmar Best corrected visual acuity (BCVA) from 1 month to that measured at baseline
Time Frame
Change from baseline BCVA measured at one month
Title
Change in Logmar Best Corrected Visual Acuity (BCVA) at Two Months
Description
Change in Logmar Best corrected visual acuity (BCVA) from 2 month to that measured at baseline
Time Frame
Change from baseline BCVA measured at two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetic Macular Oedema with centre involving thickness of >300µm
Age >= 18 years
Diagnosis of diabetes mellitus
Best corrected visual acuity of 6/9 to 6/60 (letters 77- 33)
Intraocular pressure 6 to 25 mmHg
Written informed consent has been obtained.
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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Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark C Gillies, MD PhD
Organizational Affiliation
Sydney University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sydney Eye Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
32661752
Citation
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.
Results Reference
derived
Learn more about this trial
Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema
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