Trial Outcomes & Findings for A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema (NCT NCT03866473)
NCT ID: NCT03866473
Last Updated: 2022-09-19
Results Overview
Only eyes that completed the 4-month visit were included in calculation of descriptive statistics of optical coherence tomography (OCT) data. For eyes that received alternate DME treatment prior to 4 months (N=3 \[PBM\]; N = 1 \[placebo\]), the last OCT measurements prior to alternative diabetic macular edema (DME) treatment were used in place of the 4-month measurements. All analyses followed the intent-to-treat principle. Multiple imputation (m = 100) was used for missing values of central subfield thickness and retinal volume change, with imputation models that included variables for treatment group, baseline values, and change from baseline at all monthly interim visits up to the primary outcome visit and the randomization stratification factor of recent or planned intravitreous treatment in the non-study eye. Multiple imputation was not performed for center-involved DME given the thresholds are gender and machine specific. OCT CST change was truncated to the mean ± 3 SD (13 ± 3 × 5
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
135 participants
Primary outcome timeframe
Baseline to 4 months
Results posted on
2022-09-19
Participant Flow
Visit completion at 4 months was prespecified as completion of any study visit from 12 to 24 weeks but due to the COVID19 pandemic, the window was extended to 32 weeks and participants in Phase 2 could also discontinue device use.
Unit of analysis: Eyes
Participant milestones
| Measure |
Photobiomodulation (PBM) Intervention
670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).
Retilux: 670nm wavelength light
|
Placebo Intervention
Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
Sham Light Device: Broad spectrum light device
|
|---|---|---|
|
Phase 1
STARTED
|
69 69
|
66 66
|
|
Phase 1
COMPLETED
|
68 68
|
66 66
|
|
Phase 1
NOT COMPLETED
|
1 1
|
0 0
|
|
Phase 2
STARTED
|
62 62
|
61 61
|
|
Phase 2
COMPLETED
|
60 60
|
58 58
|
|
Phase 2
NOT COMPLETED
|
2 2
|
3 3
|
Reasons for withdrawal
| Measure |
Photobiomodulation (PBM) Intervention
670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).
Retilux: 670nm wavelength light
|
Placebo Intervention
Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
Sham Light Device: Broad spectrum light device
|
|---|---|---|
|
Phase 1
Death
|
1
|
0
|
|
Phase 2
Death
|
0
|
2
|
|
Phase 2
Dropped
|
1
|
1
|
|
Phase 2
Completed the study by receiving alternate treatment for diabetic macular edema
|
1
|
0
|
Baseline Characteristics
Hemoglobin A1c was missing for 2 PBM and 2 placebo participants.
Baseline characteristics by cohort
| Measure |
Photobiomodulation (PBM)
n=69 Participants
670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).
Retilux: 670nm wavelength light
|
Placebo
n=66 Participants
Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
Sham Light Device: Broad spectrum light device
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
63 years
n=69 Participants
|
62 years
n=66 Participants
|
62 years
n=135 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=69 Participants
|
28 Participants
n=66 Participants
|
50 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=69 Participants
|
38 Participants
n=66 Participants
|
85 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=69 Participants
|
0 participants
n=66 Participants
|
1 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
4 participants
n=69 Participants
|
7 participants
n=66 Participants
|
11 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 participants
n=69 Participants
|
7 participants
n=66 Participants
|
12 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
White
|
59 participants
n=69 Participants
|
52 participants
n=66 Participants
|
111 participants
n=135 Participants
|
|
Diabetes Type
Type 1
|
5 participants
n=69 Participants
|
10 participants
n=66 Participants
|
15 participants
n=135 Participants
|
|
Diabetes Type
Type 2
|
64 participants
n=69 Participants
|
56 participants
n=66 Participants
|
120 participants
n=135 Participants
|
|
Hemoglobin A1c
Less than 7.5%
|
33 participants
n=67 Participants • Hemoglobin A1c was missing for 2 PBM and 2 placebo participants.
|
23 participants
n=64 Participants • Hemoglobin A1c was missing for 2 PBM and 2 placebo participants.
|
56 participants
n=131 Participants • Hemoglobin A1c was missing for 2 PBM and 2 placebo participants.
|
|
Hemoglobin A1c
7.5% or more
|
34 participants
n=67 Participants • Hemoglobin A1c was missing for 2 PBM and 2 placebo participants.
|
41 participants
n=64 Participants • Hemoglobin A1c was missing for 2 PBM and 2 placebo participants.
|
75 participants
n=131 Participants • Hemoglobin A1c was missing for 2 PBM and 2 placebo participants.
|
|
E-ETDRS visual acuity letter score
|
84.0 units on a scale
n=69 Participants
|
85.0 units on a scale
n=66 Participants
|
84 units on a scale
n=135 Participants
|
|
Optical coherence tomography central subfield thickness
|
352 Microns
n=69 Participants
|
355 Microns
n=66 Participants
|
354 Microns
n=135 Participants
|
|
Lens Status on Clinical Exam
Phakic (natural lens)
|
19 participants
n=69 Participants
|
15 participants
n=66 Participants
|
34 participants
n=135 Participants
|
|
Lens Status on Clinical Exam
Prosthetic intraocular lens
|
50 participants
n=69 Participants
|
51 participants
n=66 Participants
|
101 participants
n=135 Participants
|
|
Diabetic retinopathy severity
Microaneurysms only
|
0 participants
n=69 Participants
|
1 participants
n=66 Participants
|
1 participants
n=135 Participants
|
|
Diabetic retinopathy severity
Mild/moderate NPDR
|
58 participants
n=69 Participants
|
48 participants
n=66 Participants
|
106 participants
n=135 Participants
|
|
Diabetic retinopathy severity
Severe NPDR
|
7 participants
n=69 Participants
|
11 participants
n=66 Participants
|
18 participants
n=135 Participants
|
|
Diabetic retinopathy severity
Proliferative diabetic retinopathy or prior scatter laser or both.
|
4 participants
n=69 Participants
|
6 participants
n=66 Participants
|
10 participants
n=135 Participants
|
|
Atleast one prior treatment for diabetic macular edema
|
15 participants
n=69 Participants
|
12 participants
n=66 Participants
|
27 participants
n=135 Participants
|
|
Retinal Volume
|
7.72 mm^3
n=69 Participants
|
7.68 mm^3
n=66 Participants
|
7.70 mm^3
n=135 Participants
|
|
Iris color
Blue
|
19 Eyes
n=69 Participants
|
28 Eyes
n=66 Participants
|
47 Eyes
n=135 Participants
|
|
Iris color
Brown
|
31 Eyes
n=69 Participants
|
27 Eyes
n=66 Participants
|
58 Eyes
n=135 Participants
|
|
Iris color
Other
|
19 Eyes
n=69 Participants
|
11 Eyes
n=66 Participants
|
30 Eyes
n=135 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 monthsOnly eyes that completed the 4-month visit were included in calculation of descriptive statistics of optical coherence tomography (OCT) data. For eyes that received alternate DME treatment prior to 4 months (N=3 \[PBM\]; N = 1 \[placebo\]), the last OCT measurements prior to alternative diabetic macular edema (DME) treatment were used in place of the 4-month measurements. All analyses followed the intent-to-treat principle. Multiple imputation (m = 100) was used for missing values of central subfield thickness and retinal volume change, with imputation models that included variables for treatment group, baseline values, and change from baseline at all monthly interim visits up to the primary outcome visit and the randomization stratification factor of recent or planned intravitreous treatment in the non-study eye. Multiple imputation was not performed for center-involved DME given the thresholds are gender and machine specific. OCT CST change was truncated to the mean ± 3 SD (13 ± 3 × 5
Outcome measures
| Measure |
Photobiomodulation (PBM)
n=68 Eyes
670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).
Retilux: 670nm wavelength light
|
Placebo
n=66 Eyes
Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
Sham Light Device: Broad spectrum light device
|
|---|---|---|
|
Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 4 Months
|
13 microns
Standard Deviation 53
|
15 microns
Standard Deviation 57
|
SECONDARY outcome
Timeframe: Baseline to 4 monthsPopulation: Multiple imputation (m=100) was used for missing values of CST and retinal volume change, with imputation models that were stratified by treatment and included variables for treatment group, baseline values, and change from baseline at all monthly interim visits up to the primary outcome visit and the randomization stratification factor of recent or planned intravitreous treatment in the non-study eye. OCT retinal volume change was missing for 8 PBM and 5 placebo eyes.
CST = central subfield thickness, OCT = optical coherence tomography, PBM = photobiomodulation
Outcome measures
| Measure |
Photobiomodulation (PBM)
n=60 Eyes
670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).
Retilux: 670nm wavelength light
|
Placebo
n=61 Eyes
Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
Sham Light Device: Broad spectrum light device
|
|---|---|---|
|
Mean Change in Retinal Volume on Optical Coherence Tomography From Baseline to 4 Months
|
0.12 mm^3
Standard Deviation 0.45
|
0.10 mm^3
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: baseline to 4 monthsPopulation: Eyes that received alternate DME treatment (N = 3 (Photobiomodulation); N = 1 (Placebo)) used the last OCT measurement prior to receiving treatment. Missing values were not imputed.
DME = diabetic macular edema, OCT = optical coherence tomography
Outcome measures
| Measure |
Photobiomodulation (PBM)
n=68 Eyes
670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).
Retilux: 670nm wavelength light
|
Placebo
n=66 Eyes
Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
Sham Light Device: Broad spectrum light device
|
|---|---|---|
|
Number of Eyes With Center-involved Diabetic Macular Edema on Optical Coherence Tomography at 4 Months
|
61 Eyes
|
57 Eyes
|
SECONDARY outcome
Timeframe: 4 monthsOutcome measures
| Measure |
Photobiomodulation (PBM)
n=68 Eyes
670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).
Retilux: 670nm wavelength light
|
Placebo
n=66 Eyes
Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
Sham Light Device: Broad spectrum light device
|
|---|---|---|
|
Number of Eyes Receiving Alternative Treatment for Diabetic Macular Edema
|
3 Eyes
|
1 Eyes
|
SECONDARY outcome
Timeframe: baseline to 4 monthsPopulation: Multiple imputation (m=100) used for missing values of VA change, with imputation models that were stratified by treatment and included variables for baseline VA, change from baseline at all monthly interim visits up to the primary outcome visit and the randomization stratification factor of recent or planned intravitreous treatment in the non-study eye.
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart. Visual acuity (VA) change truncated to mean ±3 SD (-0.3 ± 3 × 5.3). Eyes that received alternative treatment for DME before primary outcome visit (3 PBM, 1 placebo); last measurements taken before DME treatment was initiated were the pre-specified outcome data. Missing data for eyes that didn't get alternative treatment for DME imputed with multiple imputation.
Outcome measures
| Measure |
Photobiomodulation (PBM)
n=68 Eyes
670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).
Retilux: 670nm wavelength light
|
Placebo
n=66 Eyes
Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
Sham Light Device: Broad spectrum light device
|
|---|---|---|
|
Change in Visual Acuity From Baseline to 4 Months
|
-0.2 Letter Score
Standard Deviation 5.5
|
-0.6 Letter Score
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 4 to 8 monthsOnly eyes that completed the 4-month visit were included in calculation of descriptive statistics of OCT data. For eyes that received alternate DME treatment prior to 4 months (N = 3 \[PBM\]; N = 1 \[placebo\]), the last OCT measurements prior to alternative DME treatment were used in place of the 4-month measurements. All analyses followed the intent-to-treat principle. Multiple imputation (m = 100) was used for missing values of central subfield thickness and retinal volume change, with imputation models that included variables for treatment group, baseline values, and change from baseline at all monthly interim visits up to the primary outcome visit and the randomization stratification factor of recent or planned intravitreous treatment in the non-study eye. Multiple imputation was not performed for center-involved DME given the thresholds are gender and machine specific. OCT CST change was truncated to the mean ± 3 SD (13 ± 3 × 58)
Outcome measures
| Measure |
Photobiomodulation (PBM)
n=61 Eyes
670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).
Retilux: 670nm wavelength light
|
Placebo
n=62 Eyes
Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
Sham Light Device: Broad spectrum light device
|
|---|---|---|
|
Change in Optical Coherence Tomography Central Subfield Thickness From 4 to 8 Months
|
-1 microns
Standard Deviation 44
|
-2 microns
Standard Deviation 41
|
Adverse Events
Phase 1 Photobiomodulation (PBM) Intervention
Serious events: 5 serious events
Other events: 12 other events
Deaths: 1 deaths
Phase 1 Placebo Intervention
Serious events: 9 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 2 Photobiomodulation (PBM) Intervention
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase 2 Placebo Intervention
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase 1 Photobiomodulation (PBM) Intervention
n=69 participants at risk
670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).
|
Phase 1 Placebo Intervention
n=66 participants at risk
Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
|
Phase 2 Photobiomodulation (PBM) Intervention
n=61 participants at risk
670nm wavelength device twice a day for 90 seconds 4 to 8 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
|
Phase 2 Placebo Intervention
n=62 participants at risk
Broad spectrum light device twice a day for 90 seconds 4 to 8 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
|
|---|---|---|---|---|
|
Cardiac disorders
Congestive heart failure
|
1.4%
1/69 • Number of events 1 • 8 Months
|
0.00%
0/66 • 8 Months
|
1.6%
1/61 • Number of events 1 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/69 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
1.6%
1/62 • Number of events 1 • 8 Months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
General disorders
Chest pain
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
General disorders
Chest pressure
|
0.00%
0/69 • 8 Months
|
0.00%
0/66 • 8 Months
|
1.6%
1/61 • Number of events 1 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Hepatobiliary disorders
Liver failure
|
0.00%
0/69 • 8 Months
|
0.00%
0/66 • 8 Months
|
1.6%
1/61 • Number of events 1 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Infections and infestations
COVID-19
|
—
0/0 • 8 Months
|
—
0/0 • 8 Months
|
3.3%
2/61 • Number of events 2 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Infections and infestations
Infection
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Injury, poisoning and procedural complications
Wound
|
1.4%
1/69 • Number of events 1 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Metabolism and nutrition disorders
Water retention
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Musculoskeletal and connective tissue disorders
Broken bones
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.4%
1/69 • Number of events 1 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
1.4%
1/69 • Number of events 1 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Nervous system disorders
Fainting
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Renal and urinary disorders
Chronic kidney disease
|
—
0/0 • 8 Months
|
—
0/0 • 8 Months
|
1.6%
1/61 • Number of events 1 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.4%
1/69 • Number of events 1 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Skin and subcutaneous tissue disorders
Cellulitis of arm
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Surgical and medical procedures
Back surgery
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Vascular disorders
Stroke - Ischemic
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
Other adverse events
| Measure |
Phase 1 Photobiomodulation (PBM) Intervention
n=69 participants at risk
670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).
|
Phase 1 Placebo Intervention
n=66 participants at risk
Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
|
Phase 2 Photobiomodulation (PBM) Intervention
n=61 participants at risk
670nm wavelength device twice a day for 90 seconds 4 to 8 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
|
Phase 2 Placebo Intervention
n=62 participants at risk
Broad spectrum light device twice a day for 90 seconds 4 to 8 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
|
|---|---|---|---|---|
|
Eye disorders
Blepharitis (eyelid irritation)
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Blepharo conjunctivitis
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Blurred vision
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Blurry vision
|
1.4%
1/69 • Number of events 1 • 8 Months
|
0.00%
0/66 • 8 Months
|
1.6%
1/61 • Number of events 1 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Cataract
|
1.4%
1/69 • Number of events 1 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
3.2%
2/62 • Number of events 2 • 8 Months
|
|
Eye disorders
Chalazion
|
0.00%
0/69 • 8 Months
|
0.00%
0/66 • 8 Months
|
1.6%
1/61 • Number of events 1 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Color vision change
|
2.9%
2/69 • Number of events 2 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Cotton wool spots
|
1.4%
1/69 • Number of events 1 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Diabetic macular edema
|
1.4%
1/69 • Number of events 1 • 8 Months
|
3.0%
2/66 • Number of events 2 • 8 Months
|
1.6%
1/61 • Number of events 1 • 8 Months
|
3.2%
2/62 • Number of events 3 • 8 Months
|
|
Eye disorders
Eye ache
|
1.4%
1/69 • Number of events 1 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Eye irritation
|
1.4%
1/69 • Number of events 1 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Eye itching
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Eye tearing
|
0.00%
0/69 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
1.6%
1/62 • Number of events 1 • 8 Months
|
|
Eye disorders
Eyelid margin crusting
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Floaters
|
1.4%
1/69 • Number of events 1 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
1.6%
1/62 • Number of events 1 • 8 Months
|
|
Eye disorders
Macular edema
|
1.4%
1/69 • Number of events 1 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Nuclear sclerosis
|
1.4%
1/69 • Number of events 1 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/69 • 8 Months
|
0.00%
0/66 • 8 Months
|
1.6%
1/61 • Number of events 1 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Posterior vitreous detachment
|
0.00%
0/69 • 8 Months
|
0.00%
0/66 • 8 Months
|
1.6%
1/61 • Number of events 1 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Sensitivity to light (photophobia)
|
1.4%
1/69 • Number of events 2 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Superficial punctate keratitis
|
0.00%
0/69 • 8 Months
|
0.00%
0/66 • 8 Months
|
1.6%
1/61 • Number of events 1 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Eye disorders
Vision decreased
|
0.00%
0/69 • 8 Months
|
0.00%
0/66 • 8 Months
|
3.3%
2/61 • Number of events 2 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/69 • 8 Months
|
0.00%
0/66 • 8 Months
|
0.00%
0/61 • 8 Months
|
1.6%
1/62 • Number of events 1 • 8 Months
|
|
Nervous system disorders
Burning sensation in face
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/69 • 8 Months
|
1.5%
1/66 • Number of events 1 • 8 Months
|
0.00%
0/61 • 8 Months
|
0.00%
0/62 • 8 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place