Diabetic Macular EdemaAENCT03866473
A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema
A study testing Retilux in people with Diabetic Macular Edema, run by Jaeb Center for Health Research at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Retilux
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 20 sitesUnited States
- Study dates
- 10 Apr 2019to 13 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Southeast Retina Center, PC
Augusta, Georgia, 30909
Austin Retina Associates
Austin, Texas, 78705-1169
Retina Research Center
Austin, Texas, 78705
Valley Eye Physicians and Surgeons
Ayer, Massachusetts, 01432-1191
Elman Retina Group, PA
Baltimore, Maryland, 21237
Charlotte Eye, Ear, Nose and Throat Assoc., PA
Charlotte, North Carolina, 28210
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740-6597
Atlantis Eye Care
Huntington Beach, California, 92647-8693
Raj K. Maturi, MD, PC
Indianapolis, Indiana, 46290
UF College of Medicine, Dept of Ophthalmology, Jacksonville Health Science Center
Jacksonville, Florida, 32209
Southeastern Retina Associates, PC
Knoxville, Tennessee, 37909
Marietta Eye Clinic
Marietta, Georgia, 30060
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
East Bay Retina Consultants, Inc
Oakland, California, 94609-3028
Mid-America Retina Consultants, PA
Overland Park, Kansas, 66211
Paducah Retinal Center
Paducah, Kentucky, 42001-7502
Retina Northwest PC
Portland, Oregon, 97221
California Retina Consultants
Santa Barbara, California, 93103-4223
The Retina Institute
St Louis, Missouri, 63128
About this study
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.
Read the 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
- Being tested
- Retilux, Sham Light Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetiluxDevice
Also called PBM, Photobiomodulation
670nm wavelength light
Sham Light DeviceDevice
Broad spectrum light device
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Device: Sham Light Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 4 months
Secondary outcomes (5)
Mean Change in Retinal Volume on Optical Coherence Tomography From Baseline to 4 Months
CST = central subfield thickness, OCT = optical coherence tomography, PBM = photobiomodulation
Measured: Baseline to 4 months
Number of Eyes With Center-involved Diabetic Macular Edema on Optical Coherence Tomography at 4 Months
DME = diabetic macular edema, OCT = optical coherence tomography
Measured: baseline to 4 months
Number of Eyes Receiving Alternative Treatment for Diabetic Macular Edema
Measured: 4 months
Change in Visual Acuity From 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 were the pre-specified outcome data. Missing data for eyes that didn't get alternative treatment for DME imputed with multiple imputation.
Measured: baseline to 4 months
Change in Optical Coherence Tomography Central Subfield Thickness From 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 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)
Measured: 4 to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start10 Apr 2019
- Primary completion4 Sep 2020
- Study completion13 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment (1:1) to photobiomodulation (PBM) or sham
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI), Juvenile Diabetes Research Foundation, PhotoOptx LLC
- Responsible party
- Sponsor
- Investigators
- Judy Kim, MD, Study chair, Medical College of Wisconsin Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866473
- Sponsor's protocol ID
- DRCR.net Protocol AE
- Acronym
- AE
- Status last verified
- Sep 2022
- First submitted
- 6 Mar 2019
- Last updated
- 19 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT03866473
- Acronym / sponsor ID
- AE / DRCR.net Protocol AE
- Conditions
- Diabetic Macular Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI), Juvenile Diabetes Research Foundation, PhotoOptx LLC
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Posted 10 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Random assignment (1:1) to photobiomodulation (PBM) or sham
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation (PBM) | Experimental | Device: Retilux670nm 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). |
| Placebo | Sham comparator | Device: Sham Light DeviceBroad 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RetiluxAlso: PBM, Photobiomodulation670nm wavelength light | Device | Photobiomodulation (PBM) |
| Sham Light DeviceBroad spectrum light device | Device | Placebo |
Primary outcome
Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 4 Months
Time frame: 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
5 secondary outcomes
Mean Change in Retinal Volume on Optical Coherence Tomography From Baseline to 4 Months
Time frame: Baseline to 4 months
Number of Eyes With Center-involved Diabetic Macular Edema on Optical Coherence Tomography at 4 Months
Time frame: baseline to 4 months
Number of Eyes Receiving Alternative Treatment for Diabetic Macular Edema
Time frame: 4 months
Change in Visual Acuity From Baseline to 4 Months
Time frame: baseline to 4 months
Change in Optical Coherence Tomography Central Subfield Thickness From 4 to 8 Months
Time frame: 4 to 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetic Macular Edema
Active, not recruitingPhase 2/3
A Study of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME
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RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
RecruitingPhase 2
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Enrolling by invitationPhase 3
Suprachoroidal Bevacizumab Versus Intravitreal Bevacizumab in Diabetic Macular Edema
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Kim, MD study chair
Medical College of Wisconsin Eye Institute
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retilux in people with Diabetic Macular Edema, run by Jaeb Center for Health Research at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 4 Months (time frame: Baseline to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.