Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema

NCT02181400 | Completed Results DMC

• 1 other identifier: NIRD
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Oedema

Keywords

diabetic retinopathy; diabetic macular edema; diabetic macular oedema; near infrared light therapy

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• Change in Logmar Best Corrected Visual Acuity (BCVA) at One Month.

  Change from baseline BCVA measured at one month

• Change in Logmar Best Corrected Visual Acuity (BCVA) at Two Months

  Change from baseline BCVA measured at two months

Study Arms (3)

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.

Device: Ellex Integre NIR laser

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.

Device: Ellex Integre NIR laser

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.

Device: Ellex Integre NIR laser

Interventions

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.

NIR Laser Treatment 25 miiliwatts (mW)/cm2 dose; NIR laser treatment 100mW/cm2 dose; NIR laser treatment 200mW/cm2 dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sydney: lead

Study Sites (1)

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Related Publications (1)

• 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.

  PMID: 32661752 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Maria Willilams
• Organization: Sydney Eye Hospital

maria.williams@sydney.edu.au

02 9382 7309

Study Officials

• Mark C Gillies, MD PhD

  Sydney University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 3, 2014
• Study Start: April 19, 2016
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: February 7, 2020
• Results First Posted: December 23, 2019

Record last verified: 2020-01

Locations

AU (1)