Clinical trial NCT02181400: Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema
Official title: Pilot Study of Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Oedema
Keywords: diabetic retinopathy
diabetic macular edema
diabetic macular oedema
near infrared light therapy
Lead sponsor: University of Sydney
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

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Primary outcomes:
measure: Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography( OCT) at One Month
timeFrame: Change from baseline in central macular thickness at one month
measure: Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography (OCT) at Two Months
timeFrame: Change from baseline central macular thickness at two months
measure: Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at One Month.
timeFrame: Change from baseline total macular volume at one month
measure: Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at Two Months.
timeFrame: Change from baseline total macular volume as measured by OCT at two months
Secondary outcomes:
measure: Change in Logmar Best Corrected Visual Acuity (BCVA) at One Month.
timeFrame: Change from baseline BCVA measured at one month
measure: Change in Logmar Best Corrected Visual Acuity (BCVA) at Two Months
timeFrame: Change from baseline BCVA measured at two months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
Study officials:
affiliation: Sydney University
name: Mark C Gillies, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.