Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema

Diabetic Macular Oedema Clinical Trial

— NIRD  

Official title:

Pilot Study of Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181400
• Other study ID #: NIRD
• Status: Completed
• Phase: N/A
• Start date: April 19, 2016
• Est. completion date: February 15, 2019

Study information

• Verified date: January 2020
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Diabetic Macular Oedema
• Edema
• Macular Edema

Intervention

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.

Locations

Country	Name	City	State
Australia	Sydney Eye Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Change from baseline in central macular thickness at one month
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)	Change from baseline central macular thickness at two months
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	Change from baseline total macular volume at one month
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	Change from baseline total macular volume as measured by OCT at two months
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	Change from baseline BCVA measured at one month
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	Change from baseline BCVA measured at two months