A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema

NCT ID: NCT03866473

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-10
• Study Completion Date: 2020-11-13

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.

Detailed Description

This study is being conducted to assess the effects of photobiomodulation on CST compared with sham in eyes with central-involved DME and good vision. Photobiomodulation is irradiation by light in the 630-900 nanometer region of the spectrum.

Furthermore, this pilot study is being conducted to determine whether the conduct of a pivotal trial has merit based on an anatomic outcome and provide information on outcome measures needed to design a pivotal trial.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Photobiomodulation (PBM)

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).

Group Type: EXPERIMENTAL

Retilux

Intervention Type: DEVICE

670nm wavelength light

Placebo

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)

Group Type: SHAM_COMPARATOR

Sham Light Device

Intervention Type: DEVICE

Broad spectrum light device

Interventions

Retilux

670nm wavelength light

Intervention Type: DEVICE

Sham Light Device

Broad spectrum light device

Intervention Type: DEVICE

Other Intervention Names

PBM; Photobiomodulation

Eligibility Criteria

Inclusion Criteria

• 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:

1. Current regular use of insulin for the treatment of diabetes.

2. Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes.

3. Documented diabetes by American Diabetes Association and/or the World Health Organization criteria.

4. Able and willing to provide informed consent.

Atleast one eye meeting the following criteria:

1. Best corrected E-ETDRS visual acuity letter score ≥ 79 (i.e., 20/25 or better)

2. 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

3. Media clarity, pupillary dilation, and study participant

Exclusion Criteria

• 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.
• Anticipated need to treat DME or DR during the study period
• History of topical steroid or non-steroidal anti-inflammatory drug treatment within 30 days prior to randomization.
• History of YAG capsulotomy performed within 2 months prior to randomization
• Any history of vitrectomy.
• Aphakia
• Uncontrolled glaucoma

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

PhotoOptx LLC

INDUSTRY

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judy Kim, MD

Role: STUDY_CHAIR

Medical College of Wisconsin Eye Institute

Locations

Atlantis Eye Care

Huntington Beach, California, United States

East Bay Retina Consultants, Inc

Oakland, California, United States

California Retina Consultants

Santa Barbara, California, United States

National Ophthalmic Research Institute

Fort Myers, Florida, United States

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

Jacksonville, Florida, United States

Southeast Retina Center, PC

Augusta, Georgia, United States

Marietta Eye Clinic

Marietta, Georgia, United States

Raj K. Maturi, MD, PC

Indianapolis, Indiana, United States

Mid-America Retina Consultants, PA

Overland Park, Kansas, United States

Paducah Retinal Center

Paducah, Kentucky, United States

Elman Retina Group, PA

Baltimore, Maryland, United States

Mid Atlantic Retina Specialists

Hagerstown, Maryland, United States

Valley Eye Physicians and Surgeons

Ayer, Massachusetts, United States

The Retina Institute

St Louis, Missouri, United States

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

Charlotte, North Carolina, United States

Retina Northwest PC

Portland, Oregon, United States

Southeastern Retina Associates, PC

Knoxville, Tennessee, United States

Austin Retina Associates

Austin, Texas, United States

Retina Research Center

Austin, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

DRCR.net Protocol AE

Identifier Type: -

Identifier Source: org_study_id