NIRD: Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema

• Sponsor: University of Sydney (Other)
• Overall Status: Completed
• CT.gov ID: NCT02181400
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 3
• Actual Duration (Months): 33.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Oedema	Device: Ellex Integre NIR laser	N/A

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.

Study Design

• Study Type: Interventional
• Actual 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
• Actual Study Start Date: Apr 19, 2016
• Actual Primary Completion Date: Feb 15, 2019
• Actual Study Completion Date: Feb 15, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography( OCT) at One Month [Change from baseline in central macular thickness at one month]

   Change in measurement( in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography( OCT)

2. Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography (OCT) at Two Months [Change from baseline central macular thickness at two months]

   Change in measurement (in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography (OCT)

3. Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at One Month. [Change from baseline total macular volume 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

4. Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at Two Months. [Change from baseline total macular volume as measured by OCT 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

Secondary Outcome Measures

1. 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) from 1 month to that measured at baseline

2. Change in Logmar Best Corrected Visual Acuity (BCVA) at Two Months [Change from baseline BCVA measured at two months]

   Change in Logmar Best corrected visual acuity (BCVA) from 2 month to that measured at baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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.

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sydney Eye Hospital	Sydney	New South Wales	Australia	2000

Sponsors and Collaborators

• University of Sydney

Investigators

• Principal Investigator: Mark C Gillies, MD PhD, Sydney University

Study Documents (Full-Text)

• Study Protocol - Aug 11, 2017

More Information

Publications

None provided.

• Responsible Party: University of Sydney
• ClinicalTrials.gov Identifier: NCT02181400
• Other Study ID Numbers: NIRD
• First Posted: Jul 3, 2014
• Last Update Posted: Feb 7, 2020
• Last Verified: Jan 1, 2020

• Keywords provided by University of Sydney: diabetic retinopathy; diabetic macular edema; diabetic macular oedema; near infrared light therapy
• Additional relevant MeSH terms: Macular Edema; Edema

Study Results

Participant Flow

Arm/Group Title	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	NIR Laser Treatment 100mW/cm2 Dose	NIR Laser Treatment 200mW/cm2 Dose
Arm/Group Description	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. 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.	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. 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.	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. 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.
Period Title: Overall Study
STARTED	7	7	7
COMPLETED	7	7	7
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	NIR Laser Treatment 100mW/cm2 Dose	NIR Laser Treatment 200mW/cm2 Dose	Total
Arm/Group Description	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. 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.	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. 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.	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. 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.	Total of all reporting groups
Overall Participants	7	7	7	21
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	1 14.3%	3 42.9%	6 85.7%	10 47.6%
>=65 years	6 85.7%	4 57.1%	1 14.3%	11 52.4%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	73	63	60	65
Sex: Female, Male (Count of Participants)
Female	1 14.3%	1 14.3%	0 0%	2 9.5%
Male	6 85.7%	6 85.7%	7 100%	19 90.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Australia	7 100%	7 100%	7 100%	21 100%
Visual Acuity change (letters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [letters]	64.6 (10.8)	64.3 (7.3)	68.8 (13.3)	65.9 (11.7)

Outcome Measures

1. Primary Outcome

Title	Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography( OCT) at One Month
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	NIR Laser Treatment 100mW/cm2 Dose	NIR Laser Treatment 200mW/cm2 Dose
Arm/Group Description	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. 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.	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. 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.	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. 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.
Measure Participants	7	7	7
Mean (Standard Deviation) [micrometers]	-25.2 (35.1)	-29.9 (38.6)	-58.9 (45.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose, NIR Laser Treatment 100mW/cm2 Dose, NIR Laser Treatment 200mW/cm2 Dose
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	ANCOVA
	Comments

2. Primary Outcome

Title	Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography (OCT) at Two Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	NIR Laser Treatment 100mW/cm2 Dose	NIR Laser Treatment 200mW/cm2 Dose
Arm/Group Description	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. 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.	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. 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.	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. 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.
Measure Participants	7	7	7
Mean (Standard Deviation) [micrometers]	-52.5 (23.6)	-128.6 (51.4)	-114 (59.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose, NIR Laser Treatment 100mW/cm2 Dose, NIR Laser Treatment 200mW/cm2 Dose
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	ANCOVA
	Comments

3. Primary Outcome

Title	Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at One Month.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	NIR Laser Treatment 100mW/cm2 Dose	NIR Laser Treatment 200mW/cm2 Dose
Arm/Group Description	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. 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.	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. 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.	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. 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.
Measure Participants	7	7	7
Mean (Standard Deviation) [millimeter cube]	0.1 (0.4)	0 (0.1)	-0.3 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose, NIR Laser Treatment 100mW/cm2 Dose, NIR Laser Treatment 200mW/cm2 Dose
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	ANCOVA
	Comments

4. Primary Outcome

Title	Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at Two Months.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	NIR Laser Treatment 100mW/cm2 Dose	NIR Laser Treatment 200mW/cm2 Dose
Arm/Group Description	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. 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.	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. 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.	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. 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.
Measure Participants	7	7	7
Mean (Standard Deviation) [millimeters cube]	-0.2 (0.1)	0.2 (0.7)	-0.2 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose, NIR Laser Treatment 100mW/cm2 Dose, NIR Laser Treatment 200mW/cm2 Dose
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments
	Method	ANCOVA
	Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	NIR Laser Treatment 100mW/cm2 Dose	NIR Laser Treatment 200mW/cm2 Dose
Arm/Group Description	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. 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.	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. 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.	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. 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.
Measure Participants	7	7	7
Mean (Standard Deviation) [letters]	4 (2.0)	2 (4)	6 (13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose, NIR Laser Treatment 100mW/cm2 Dose, NIR Laser Treatment 200mW/cm2 Dose
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANCOVA
	Comments

6. Secondary Outcome

Title	Change in Logmar Best Corrected Visual Acuity (BCVA) at Two Months
Description	Change in Logmar Best corrected visual acuity (BCVA) from 2 month to that measured at baseline
Time Frame	Change from baseline BCVA measured at two months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose	NIR Laser Treatment 100mW/cm2 Dose	NIR Laser Treatment 200mW/cm2 Dose
Arm/Group Description	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. 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.	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. 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.	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. 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.
Measure Participants	7	7	7
Mean (Standard Deviation) [letters]	4 (6)	-2 (7)	-3 (9.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose, NIR Laser Treatment 100mW/cm2 Dose, NIR Laser Treatment 200mW/cm2 Dose
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.49
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	AEs and SAEs ocular and non-ocular were reported for the whole period in which the participant was in the trial. 16 weeks
Arm/Group Title	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose		NIR Laser Treatment 100mW/cm2 Dose		NIR Laser Treatment 200mW/cm2 Dose
Arm/Group Description	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. 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.		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. 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.		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. 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.
All Cause Mortality
	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose		NIR Laser Treatment 100mW/cm2 Dose		NIR Laser Treatment 200mW/cm2 Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)		0/7 (0%)
Serious Adverse Events
	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose		NIR Laser Treatment 100mW/cm2 Dose		NIR Laser Treatment 200mW/cm2 Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose		NIR Laser Treatment 100mW/cm2 Dose		NIR Laser Treatment 200mW/cm2 Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/7 (100%)		4/7 (57.1%)		6/7 (85.7%)
General disorders
Unrelated to study treatment systemic adverse events	7/7 (100%)		4/7 (57.1%)		6/7 (85.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.