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Trial record 1 of 1121 for:    Protocol AE
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A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema (AE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03866473
Recruitment Status : Active, not recruiting
First Posted : March 7, 2019
Last Update Posted : July 16, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Eye Institute (NEI)
Juvenile Diabetes Research Foundation
PhotoOptx LLC
Information provided by (Responsible Party):
Jaeb Center for Health Research

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Device: Retilux Device: Sham Light Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Random assignment (1:1) to photobiomodulation (PBM) or sham
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema
Actual Study Start Date : April 10, 2019
Actual Primary Completion Date : April 21, 2020
Estimated Study Completion Date : August 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Retilux Photobiomodulation
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
670nm wavelength light
Other Names:
  • PBM
  • Photobiomodulation

Sham Comparator: Sham Light Device
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
Broad spectrum light device




Primary Outcome Measures :
  1. Mean Change in Central Subfield Thickness [ Time Frame: Baseline, 4 months, 8 months ]

Secondary Outcome Measures :
  1. Mean change in retinal volume [ Time Frame: Baseline, 4 months, 8 months ]
    Treatment group comparison

  2. Percentage of eyes with optical coherence tomography central subfield thickness below the gender-specific spectral domain optical coherence tomography equivalent of 250 µm on Zeiss Stratus optical coherence tomography [ Time Frame: 4 months, 8 months ]
  3. Percentage of eyes receiving alternative treatment for diabetic macular edema [ Time Frame: 4 months, 8 months ]
  4. Percentage of eyes with a ≥5 letter loss in visual acuity [ Time Frame: 4 months, 8 months ]
    electronic early treatment diabetic retinopathy study visual acuity letter score

  5. Patient Compliance [ Time Frame: 4 months, 8 months ]
    The total number of sessions of the study device use.


Other Outcome Measures:
  1. Mean Change in central subfield thickness [ Time Frame: Between 4 and 8 Months ]
    On optical coherence tomography

  2. Mean Change in Retinal Volume [ Time Frame: Between 4 and 8 Months ]
  3. Percentage of eyes with optical coherence tomography central subfield thickness below the gender-specific spectral domain optical coherence tomography equivalent of 250 µm on Zeiss Stratus optical coherence tomography [ Time Frame: Between 4 and 8 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866473


Locations
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Sponsors and Collaborators
Jaeb Center for Health Research
National Institutes of Health (NIH)
National Eye Institute (NEI)
Juvenile Diabetes Research Foundation
PhotoOptx LLC
Investigators
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Study Chair: Judy Kim, MD Medical College of Wisconsin Eye Institute
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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT03866473    
Other Study ID Numbers: DRCR.net Protocol AE
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases