Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema (NIRD)

January 28, 2020 updated by: University of Sydney

Pilot Study of Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Sydney Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diabetic Macular Oedema with centre involving thickness of >300µm
  2. Age >= 18 years
  3. Diagnosis of diabetes mellitus
  4. Best corrected visual acuity of 6/9 to 6/60 (letters 77- 33)
  5. Intraocular pressure 6 to 25 mmHg
  6. 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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography( OCT) at One Month
Time Frame: 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)
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
Time Frame: 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)
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.
Time Frame: 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
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.
Time Frame: 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
Change from baseline total macular volume as measured by OCT at two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Logmar Best Corrected Visual Acuity (BCVA) at One Month.
Time Frame: Change from baseline BCVA measured 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
Time Frame: Change from baseline BCVA measured at two months
Change in Logmar Best corrected visual acuity (BCVA) from 2 month to that measured at baseline
Change from baseline BCVA measured at two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sydney

Investigators

  • Principal Investigator: Mark C Gillies, MD PhD, Sydney University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2016

Primary Completion (Actual)

February 15, 2019

Study Completion (Actual)

February 15, 2019

Study Registration Dates

First Submitted

June 27, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 3, 2014

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIRD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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