A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema

NCT03866473 | Completed Results DMC FDA Device

• 1 other identifier: DRCR.net Protocol AE
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Change in Optical Coherence Tomography Central Subfield Thickness From 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 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

  Baseline to 4 months

Secondary Outcomes (5)

• Mean Change in Retinal Volume on Optical Coherence Tomography From Baseline to 4 Months

  Baseline to 4 months

• Number of Eyes With Center-involved Diabetic Macular Edema on Optical Coherence Tomography at 4 Months

  baseline to 4 months

• Number of Eyes Receiving Alternative Treatment for Diabetic Macular Edema

  4 months

• Change in Visual Acuity From Baseline to 4 Months

  baseline to 4 months

• Change in Optical Coherence Tomography Central Subfield Thickness From 4 to 8 Months

  4 to 8 months

Study Arms (2)

Photobiomodulation (PBM)

EXPERIMENTAL

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).

Device: Retilux

Placebo

SHAM COMPARATOR

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)

Device: Sham Light Device

Interventions

Retilux DEVICE

670nm wavelength light

Also known as: PBM, Photobiomodulation

Photobiomodulation (PBM)

Sham Light Device DEVICE

Broad spectrum light device

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present:
• Current regular use of insulin for the treatment of diabetes.
• Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes.
• Documented diabetes by American Diabetes Association and/or the World Health Organization criteria.
• Able and willing to provide informed consent.
• Atleast one eye meeting the following criteria:
• Best corrected E-ETDRS visual acuity letter score ≥ 79 (i.e., 20/25 or better)
• Ophthalmoscopic evidence of central-involved DME, confirmed by CST on spectral domain OCT: Zeiss Cirrus: ≥290µm in women, and ≥305µm in men, Heidelberg Spectralis: ≥305µm in women, and ≥320µm in men
• Media clarity, pupillary dilation, and study participant

You may not qualify if:

• History of chronic renal failure requiring dialysis or kidney transplant.
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status that might preclude completion of follow-up).
• Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months.
• Participation in an investigational trial that involved treatment within 30 days of randomization with any drug/device that has not received regulatory approval for the indication being studied. Note: study participants cannot participant in another investigational trial that involves treatment with an investigational drug or device while participating in the study.
• Systolic blood pressure above 180 or diastolic blood pressure above 110. If blood pressure is brought below 180 systolic and 110 diastolic by anti-hypertensive treatment, individual can become eligible.
• Systemic anti-vascular endothelial growth factor (anti-VEGF) or pro-VEGF treatment within 4 months prior to randomization. These drugs should not be used during the study.
• For women of child-bearing potential: pregnant or intending to become pregnant within the next 8 months. Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
• Individual is expecting to move out of the area during the 8 months of the study.
• A participant will be excluded if the study eye meets any of the following criteria:
• Macular edema is considered to be due to a cause other than DME. An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or investigator assessment of OCT suggests that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are contributing to the macular edema.
• An ocular condition is present such that, in the opinion of the investigator, any visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition).
• An ocular condition is present (other than DME) that, in the opinion of the investigator, might affect visual acuity during the course of the study or require intraocular treatment (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.)
• Cataract is present that, in the opinion of the investigator, may alter visual acuity during the course of the study.
• History of major ocular surgery (including cataract, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery anticipated during the study period.
• Any history of prior laser or other surgical, intravitreal, or peribulbar treatment for DME or DR (such as panretinal photocoagulation, focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, or anti-VEGF) within the prior 12 months. If treatment was given more than 12 months prior, no more than 4 prior intraocular injections. Enrollment will be limited to a maximum of 15 percent of the planned sample size with any history of anti-VEGF treatment and a maximum of 15% with any history of PRP.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Institutes of Health (NIH): collaborator
• National Eye Institute (NEI): collaborator
• Juvenile Diabetes Research Foundation: collaborator
• PhotoOptx LLC: collaborator

Study Sites (20)

Atlantis Eye Care

Huntington Beach, California, 92647-8693, United States

Location

East Bay Retina Consultants, Inc

Oakland, California, 94609-3028, United States

Location

California Retina Consultants

Santa Barbara, California, 93103-4223, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

UF College of Medicine, Dept of Ophthalmology, Jacksonville Health Science Center

Jacksonville, Florida, 32209, United States

Location

Southeast Retina Center, PC

Augusta, Georgia, 30909, United States

Location

Marietta Eye Clinic

Marietta, Georgia, 30060, United States

Location

Raj K. Maturi, MD, PC

Indianapolis, Indiana, 46290, United States

Location

Mid-America Retina Consultants, PA

Overland Park, Kansas, 66211, United States

Location

Paducah Retinal Center

Paducah, Kentucky, 42001-7502, United States

Location

Elman Retina Group, PA

Baltimore, Maryland, 21237, United States

Location

Mid Atlantic Retina Specialists

Hagerstown, Maryland, 21740-6597, United States

Location

Valley Eye Physicians and Surgeons

Ayer, Massachusetts, 01432-1191, United States

Location

The Retina Institute

St Louis, Missouri, 63128, United States

Location

Charlotte Eye, Ear, Nose and Throat Assoc., PA

Charlotte, North Carolina, 28210, United States

Location

Retina Northwest PC

Portland, Oregon, 97221, United States

Location

Southeastern Retina Associates, PC

Knoxville, Tennessee, 37909, United States

Location

Austin Retina Associates

Austin, Texas, 78705-1169, United States

Location

Retina Research Center

Austin, Texas, 78705, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Adam Glassman
• Organization: JAEB CENTER FOR HEALTH RESEARCH

drcrnet@jaeb.org

8139758690

Study Officials

• Judy Kim, MD

  Medical College of Wisconsin Eye Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Optical coherence tomography technicians and visual acuity testers, including refractionists, will be masked to treatment group at outcome visits. Study participants will be masked to their treatment group assignment. Every effort will be made to keep investigators masked. Study coordinators who will be involved with training and compliance assessment will not be masked to treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random assignment (1:1) to photobiomodulation (PBM) or sham

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 7, 2019
• Study Start: April 10, 2019
• Primary Completion: September 4, 2020
• Study Completion: November 13, 2020
• Last Updated: September 19, 2022
• Results First Posted: June 10, 2022

Record last verified: 2022-09

Locations

US (20)