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Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema (NIRD)

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ClinicalTrials.gov Identifier: NCT02181400
Recruitment Status : Unknown
Verified June 2014 by University of Sydney.
Recruitment status was:  Not yet recruiting
First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
University of Sydney

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.

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 folllow up will be assessed at 3 and 6 months post treatment.


Condition or disease Intervention/treatment Phase
Diabetic Macular Oedema Device: Ellex Integre NIR laser Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pilot Study of Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema
Study Start Date : July 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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.





Primary Outcome Measures :
  1. 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 ]
  2. 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 month ]
  3. change in total macular volume as measured by Spectral Domain Optical Coherence Tomography (in microns). [ Time Frame: Change from baseline total macular volume at one month ]
  4. Change in total macular volume as measured by Spectral Domain Optical Coherence Tomography [ Time Frame: Change from baseline total macular volume as measured by OCT at two months ]

Secondary Outcome Measures :
  1. Change in Logmar Best corrected visual acuity (BCVA) [ Time Frame: Change from baseline BCVA measured at 2 months ]
  2. Change in Logmar best corrected visual acuity (BCVA) [ Time Frame: Change from baseline BCVA measured at one month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181400


Contacts
Contact: Mark C Gillies, MD PhD +612 93827309 mark.gillies@sydney.edu.au
Contact: Maria D Williams, BA BN +612 93827309 maria.williams@sydney.edu.au

Locations
Australia, New South Wales
Sydney Eye Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2000
Principal Investigator: Mark C Gillies, MD PhD         
Sponsors and Collaborators
University of Sydney
Investigators
Principal Investigator: Mark C Gillies, MD PhD Sydney University

Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT02181400     History of Changes
Other Study ID Numbers: NIRD
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: June 2014

Keywords provided by University of Sydney:
diabetic retinopathy
diabetic macular edema
diabetic macular oedema
near infrared light therapy

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases