Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema

University of Sydney21 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetic Macular Oedema

Interventions

Ellex Integre NIR laserDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 \-

Locations (1)

Sydney Eye Hospital

Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: Change from baseline total macular volume as measured by OCT at two months

Secondary Outcomes

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

Time frame: Change from baseline BCVA measured at one month

Data from ClinicalTrials.gov

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