Photobiomodulation for the Treatment of Diabetic Macular Edema (PTDME)

September 6, 2019 updated by: Judy Kim, Medical College of Wisconsin

Near-Infrared Photobiomodulation for the Treatment of Diabetic Macular Edema

The current application proposes to conduct a prospective, clinical trial in diabetic subjects with diabetic macular edema (DME) to evaluate the therapeutic efficacy of 670 nm photobiomodulation on validated clinical outcome measures and anatomical changes in central macula by optical coherence tomography (OCT) and other imaging modalities. A total of 30 diabetic patients with treatment-refractory clinically significant diabetic macular edema will be included in this study and randomized into two equal groups. One eye per participant will be included to avoid exposure of both eyes to the study intervention. If both eyes are eligible, the eye with worse visual acuity will become the study eye. One group will be treated with standard-of-care (intravitreal anti-VEGF agent) injections. The photobiomodulaton (PBM) intervention group will be treated with the standard-of-care intravitreal anti-VEGF (vascular endothelial growth factor) injections and 670 nm PBM in one eye. Baseline functional and anatomic assessments will be made and anti-VEGF therapy will be administered as determined by the treating Ophthalmologist.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 30 diabetic patients with treatment-refractory clinically significant diabetic macular edema will be included in this study and randomized into two equal groups. One eye per participant will be included to avoid exposure of both eyes to the study intervention. If both eyes are eligible, the eye with worse visual acuity will become the study eye. One group will be treated with standard-of-care (intravitreal anti-VEGF agent) injections. The PBM intervention group will be treated with the standard-of-care intravitreal anti-VEGF injections and 670 nm PBM in one eye. Baseline functional and anatomic assessments will be made and anti-VEGF therapy will be administered as determined by the treating Ophthalmologist.

Subjects in the PBM intervention arm will be treated (in addition to standard care) with 670nm light (WARP10, Quantum, Devices, Inc, Barneveld, WI). The portable, battery-operated 670 nm LED array specifically designed not to generate heat will be hand held 1 inch from the closed treatment eye. An 80-sec light treatment will be delivered. After 80 sec a timer turns off the light. The dose of light delivered at the surface of the cornea is calculated to be 4.0 J/cm2 (80 sec x 0.05 W/cm2 = 4.0 J/cm2). PBM treatment will be applied for 80 sec once per day, three consecutive days per week for 8 weeks. Previous clinical studies, have shown this treatment regimen and dose to be safe and effective in the treatment of dry AMD and non-center involving DME.

ASSESSMENTS: Subjects will undergo a detailed functional and structural evaluation at baseline and at 8 and 24 weeks. Seven-field color fundus photographs will be obtained for ETDRS retinopathy grading at baseline 8 and 24 weeks. Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) will be obtained at every visit. Fundus fluorescein angiography and Spectralis OCT scans will be obtained according to predefined protocols. Blood pressure and glycosylated hemoglobin level will be recorded at baseline and 8 and 24 weeks to identify any changes in systemic status that could affect retinopathy grade and macular edema. Cataract status will be recorded at baseline and 8 and 24 weeks as a safety measure and as a possible confounding factor for visual acuity assessment.

OUTCOME MEASURES: Functional measure will be change in ETDRS BCVA from baseline. Structural outcome measures will include changes in qualitative and quantitative OCT parameters, including macular thickness and volume in 9 ETDRS subfields, obtained from automated measures in the Heidelberg Eye Explorer software (Heidelberg Engineering GmbH, Heidelberg, Germany) without formally correcting for boundary detection error; these measures are highly reproducible. Changes in intraretinal and subretinal fluid on OCT will be evaluated. The change in ETDRS severity grade of diabetic retinopathy will be reported from 7-field color fundus photographs. Safety parameters will include the reporting of ocular and nonocular adverse events. Changes to the greatest linear dimension and area of the foveal avascular zone on fluorescein angiography, together with the degree of perifoveal capillary loss, will be reported. The grading of photographs both for retinopathy grade and foveal avascular zone measurements will be carried out by a trained and certified senior diabetic retinopathy grader at the Medical College of Wisconsin. The number of anti-VEGF treatments in the two arms will be compared as a secondary measure of effect of PBM.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Froedert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Adult patients with type 1 or 2 diabetes

Exclusion Criteria:

Uncontrolled glaucoma; aphasia cataract precluding fundus photography; external ocular infections; previous anti-VEGF or laser treatment in the preceding 3 months in both eyes; angiographic evidence of macular ischemia macular edema glycosylated hemoglobin of more than 11.0% past medical history of chronic renal failure an arteriothrombotic event within 6 months before randomization pregnancy or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravitreous VEGF-inhibitors
Three intravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used for the treatment of diabetic macular edema causing vision impairment and have been shown to be beneficial and relatively safe. Study participants in the anti-VEGF group will be treated with intravitreous injections of one of these agents: afibercept (2.0 mg), bevacizumab (1.25 mg) or ranibizumab (0.5 mg) at appropriate intervals as determined by the treating ophthalmologist.
Drug: intravitreous VEGF-inhibitors
Threeintravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used for the treatment of diabetic macular edema causing vision impairment and have been shown to be beneficial and relatively safe. Study participants in the anti-VEGF group will be treated with intravitreous injections of one of these agents: afibercept (2.0 mg), bevacizumab (1.25 mg) or ranibizumab (0.5 mg) at appropriate intervals as determined by the treating ophthalmologist.
Other Names:
  • aflibercept, bevacizumab, or ranibizumab
Experimental: 670nm PBM plus VEGF-inhibitors
Subjects in the 670 nm Photobiomodulation (PBM) intervention arm will be treated (in addition to Anti-VEGF treatment) with 670nm light (WARP10, Quantum, Devices, Inc, Barneveld, WI). The portable, battery-operated 670 nm LED array specifically designed not to generate heat will be held 1 inch from the closed treatment eye. A 90-sec light treatment will be delivered. After 90 sec a timer turns off the light. The dose of light delivered at the surface of the cornea is calculated to be 4.5 J/cm2 (90 sec x 0.05 W/cm2 = 4.5 J/cm2). PBM treatment will be applied for 90 sec once per day, three consecutive days per week for 8 weeks. Previous clinical studies, have shown this treatment regimen and dose to be safe and effective in the treatment of dry AMD and non-center involving DME
Drug: intravitreous VEGF-inhibitors
Threeintravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used for the treatment of diabetic macular edema causing vision impairment and have been shown to be beneficial and relatively safe. Study participants in the anti-VEGF group will be treated with intravitreous injections of one of these agents: afibercept (2.0 mg), bevacizumab (1.25 mg) or ranibizumab (0.5 mg) at appropriate intervals as determined by the treating ophthalmologist.
Other Names:
  • aflibercept, bevacizumab, or ranibizumab
Device: 670nm PBM
Battery operated, hand-held, 10 cm2 Light Emitting Diode (LED) array designed to deliver 50 mW/cm2 of light for 90 seconds resulting in a light dose of 4.5 Joules/cm2
Other Names:
  • WARP10 by Quantum Devices, Inc (Barneveld, WI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity as assessed by the Early Treatment of Diabetic Retinopathy Study (EDTRS) Classification
Time Frame: Change from baseline at 8 weeks; Change from baseline at 24 weeks
Change from baseline at 8 weeks; Change from baseline at 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Spectral Density-Optical Coherence Tomography (SD-OCT)
Time Frame: Change from baseline at 8 weeks; Change from baseline at 24 weeks
Change from baseline at 8 weeks; Change from baseline at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

University of Wisconsin, Milwaukee

Investigators

  • Principal Investigator: Judy Kim, MD, MCW Dept of Ophthalmology
  • Principal Investigator: Sandeep Gopalakrishnan, Ph.D., UW-Milwaukee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

May 25, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 29, 2015

Study Record Updates

Last Update Posted (Actual)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 6, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00024065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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