NCT03866473: AE

A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema

Completed NA Results posted Last updated 19 September 2022

What this trial tests

NA trial testing Retilux in Diabetic Macular Edema in 135 participants. Completed in 13 November 2020.

Timeline

10 April 2019

Primary endpoint
4 September 2020

13 November 2020

Quick facts

Lead sponsor	Jaeb Center for Health Research
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	135
Start date	10 April 2019
Primary completion	4 September 2020
Estimated completion	13 November 2020
Sites	20 locations across United States

Drugs / interventions tested

• Retilux
• Sham Light Device

Conditions studied

• Diabetic Macular Edema — all drugs for Diabetic Macular Edema →

Sponsor

Jaeb Center for Health Research — full company profile →

Who can join

18 and older, any sex, with Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 4 Months Primary · Baseline to 4 months

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 treatm

Group	Value	95% CI
Photobiomodulation (PBM)	13	± 53
Placebo	15	± 57

Mean Change in Retinal Volume on Optical Coherence Tomography From Baseline to 4 Months Secondary · Baseline to 4 months

CST = central subfield thickness, OCT = optical coherence tomography, PBM = photobiomodulation

Group	Value	95% CI
Photobiomodulation (PBM)	0.12	± 0.45
Placebo	0.10	± 0.42

Number of Eyes With Center-involved Diabetic Macular Edema on Optical Coherence Tomography at 4 Months Secondary · baseline to 4 months

DME = diabetic macular edema, OCT = optical coherence tomography

Group	Value	95% CI
Photobiomodulation (PBM)	61
Placebo	57

Number of Eyes Receiving Alternative Treatment for Diabetic Macular Edema Secondary · 4 months

Group	Value	95% CI
Photobiomodulation (PBM)	3
Placebo	1

Change in Visual Acuity From Baseline to 4 Months Secondary · baseline to 4 months

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 w

Group	Value	95% CI
Photobiomodulation (PBM)	-0.2	± 5.5
Placebo	-0.6	± 4.6

Change in Optical Coherence Tomography Central Subfield Thickness From 4 to 8 Months Secondary · 4 to 8 months

Only 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 a

Group	Value	95% CI
Phase 2 Photobiomodulation (PBM)	-1	± 44
Phase 2 Placebo	-2	± 41

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 Months. Reporting threshold: 0.01%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1 Photobiomodulation (PBM) Intervention

Serious: 5/69 (7%)

Deaths: 1/69

Phase 1 Placebo Intervention

Serious: 9/66 (14%)

Deaths: 0/66

Phase 2 Photobiomodulation (PBM) Intervention

Serious: 4/61 (7%)

Deaths: 0/61

Phase 2 Placebo Intervention

Serious: 1/62 (2%)

Deaths: 2/62

Serious adverse events (23 terms)

Reaction	System	Phase 1 Photobiomodulation…	Phase 1 Placebo Intervention	Phase 2 Photobiomodulation…	Phase 2 Placebo Intervention
COVID-19	Infections and infestations	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Congestive heart failure	Cardiac disorders	—	—	—	—
Appendicitis	Gastrointestinal disorders	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—
Chest pain	General disorders	—	—	—	—
Chest pressure	General disorders	—	—	—	—
Acute cholecystitis	Hepatobiliary disorders	—	—	—	—
Liver failure	Hepatobiliary disorders	—	—	—	—
Infection	Infections and infestations	—	—	—	—
Wound	Injury, poisoning and procedural complications	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—
Water retention	Metabolism and nutrition disorders	—	—	—	—
Broken bones	Musculoskeletal and connective tissue disorders	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Fainting	Nervous system disorders	—	—	—	—
Chronic kidney disease	Renal and urinary disorders	—	—	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Cellulitis of arm	Skin and subcutaneous tissue disorders	—	—	—	—
Back surgery	Surgical and medical procedures	—	—	—	—
Stroke - Ischemic	Vascular disorders	—	—	—	—
Chronic kidney disease	Renal and urinary disorders	—	—	—	—

Other adverse events (25 terms — click to expand)

Reaction	System	Phase 1 Photobiomodulation…	Phase 1 Placebo Intervention	Phase 2 Photobiomodulation…	Phase 2 Placebo Intervention
Cataract	Eye disorders	—	—	—	—
Color vision change	Eye disorders	—	—	—	—
Diabetic macular edema	Eye disorders	—	—	—	—
Vision decreased	Eye disorders	—	—	—	—
Blepharitis (eyelid irritation)	Eye disorders	—	—	—	—
Blepharo conjunctivitis	Eye disorders	—	—	—	—
Blurred vision	Eye disorders	—	—	—	—
Blurry vision	Eye disorders	—	—	—	—
Chalazion	Eye disorders	—	—	—	—
Cotton wool spots	Eye disorders	—	—	—	—
Eye ache	Eye disorders	—	—	—	—
Eye irritation	Eye disorders	—	—	—	—
Eye itching	Eye disorders	—	—	—	—
Eye tearing	Eye disorders	—	—	—	—
Eyelid margin crusting	Eye disorders	—	—	—	—
Floaters	Eye disorders	—	—	—	—
Macular edema	Eye disorders	—	—	—	—
Nuclear sclerosis	Eye disorders	—	—	—	—
Ocular discomfort	Eye disorders	—	—	—	—
Posterior vitreous detachment	Eye disorders	—	—	—	—
Sensitivity to light (photophobia)	Eye disorders	—	—	—	—
Superficial punctate keratitis	Eye disorders	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—
Burning sensation in face	Nervous system disorders	—	—	—	—
Itching	Skin and subcutaneous tissue disorders	—	—	—	—

Most-reported serious reactions: COVID-19, COVID-19, Congestive heart failure, Appendicitis, Pancreatitis, Chest pain, Chest pressure, Acute cholecystitis.

Data from ClinicalTrials.gov NCT03866473 adverse events section.

Sponsor's own description

Randomized clinical trial evaluating the effect of photobiomodulation compared with sham on central subfield thickness (CST) in eyes with central-involved DME and good vision.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mitochondrial Defects Drive Degenerative Retinal Diseases.
   Ferrington DA, Fisher CR, Kowluru RA. · · 2020 · cited 123× · PMID 31771932 · DOI 10.1016/j.molmed.2019.10.008
2. Photobiomodulation Therapy for Age-Related Macular Degeneration and Diabetic Retinopathy: A Review.
   Muste JC, Russell MW, Singh RP. · · 2021 · cited 21× · PMID 34511875 · DOI 10.2147/opth.s272327
3. Optical Coherence Tomography Angiography Quality Across Three Multicenter Clinical Studies of Diabetic Retinopathy.
   Lujan BJ, Calhoun CT, Glassman AR, Googe JM, et al · · 2021 · cited 21× · PMID 34003936 · DOI 10.1167/tvst.10.3.2
4. 670nm photobiomodulation modulates bioenergetics and oxidative stress, in rat Müller cells challenged with high glucose.
   Nonarath HJ, Hall AE, SenthilKumar G, Abroe B, et al · · 2021 · cited 17× · PMID 34860856 · DOI 10.1371/journal.pone.0260968
5. Red Light Irradiation In Vivo Upregulates DJ-1 in the Retinal Ganglion Cell Layer and Protects against Axotomy-Related Dendritic Pruning.
   Beirne K, Freeman TJ, Rozanowska M, Votruba M. · · 2021 · cited 7× · PMID 34445085 · DOI 10.3390/ijms22168380
6. Roles of 670 nm Photobiomodulation on Rat Anterior Ischemic Optic Neuropathy: Enhancing RGC Survival, Mitochondrial Function, and Anti-Inflammatory Response.
   Chen TW, Wen YT, Liu PK, Hossen M, et al · · 2025 · cited 2× · PMID 40722990 · DOI 10.3390/antiox14070886