Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study

This study has been completed.
Sponsor:
Collaborator:
The New York Eye & Ear Infirmary
Information provided by (Responsible Party):
Harry T Whelan, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00846092
First received: February 16, 2009
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

Summary of Study Rationale Near-infrared light (NIR) via light-emitting diodes (LED) treatment promotes retinal healing and improve visual function following high intensity laser retinal injury by augmenting cellular energy metabolism, enhances mitochondrial function, increases cytochrome C oxidase activity, stimulates antioxidant protective pathways, and promotes cell survival. LED directly benefits injured neurons in the retina, the lateral geniculate nucleus, and the visual cortex, where perception occurs. From a public health perspective, a Light-Emitting Diode (LED) Array study is important to conduct because it has been approved as a non-significant risk (NSR) device for treatment of eye disorders, it has a low cost of treatment, and it may serve as an effective, non-invasive alternative or adjunctive treatment to laser photocoagulation, the current standard of care for DME.

Study Objectives and Hypotheses

  1. To determine the effects of short term (3 month) near-infrared light (NIR) therapy on anatomic and functional abnormalities of diabetic macular edema as assessed by visual acuity, optical coherence tomography, multifocal electroretinography (mERG) and fundus bimicroscopy.
  2. To assess safety of short term near-infrared light therapy in eyes with diabetic macular edema.

Condition Intervention Phase
Diabetic Macular Edema
Device: Warp 10 LED Device
Device: Near-infrared light (NIR)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study To Determine the Effects of Short Term Near-infrared Light (NIR) Therapy on Anatomic and Functional Abnormalities of Diabetic Macular Edema, and Assess Safety of Short Term Near-infrared Light Therapy in Eyes With Diabetic Macular Edema.

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Excess retinal thickness on OCT at 1 month, 3 months and 6 months. goal = reduce excess thickness by at least 50% [ Time Frame: 1 month, 3 months and 6 months ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: November 2007
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device
  • The study will require 20 subjects.
  • Each subject will have one "study eye" that will be designated for treatment.
  • Subjects will be exposed to light emitted from Warp 10 LED's (Quantum Devices, Barneveld, WI) at wavelengths of 670 nm (+/-15nm) with a minimum exposure of 4 J/cm2 (4.0 - 7.68J/cm2). This is accomplished by applying the 50 mW/cm2 (50 - 80 mw/cm2) LED-generated light to the study eye.
  • Treatments involve application of the LED-generated light for 80 seconds, twice daily.

Primary efficacy and toxicity outcomes are determined by measuring excess retinal thickness via Ocular Coherence Tomography at 1 month, 3 months, and 6 months, prior to conclusion of the study.

• This protocol will be stopped if, at any point in the study, a 50% increase in excess retinal thickness is demonstrated via OCT in 25% of subjects in the experimental group.

Device: Warp 10 LED Device
Study Subjects will take the Warp 10 (LED) home and treat twice per day for three months
Other Name: Warp 10
Device: Near-infrared light (NIR)
  • Subjects will be exposed to light emitted from LED's at wavelengths of 670 nm (+/-15nm) with a minimum exposure of 4 J/cm2 (4.0 - 7.68J/cm2). This is accomplished by applying the 50 mW/cm2 (50 - 80 mw/cm2) LED-generated light to the study eye.
  • Treatments involve application of the LED-generated light for 80 seconds, twice daily.
Other Name: Warp 10 LED's

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >= 18 years Subjects <18 years old are not being included because DME is so rare in this age group that the diagnosis of DME may be questionable.
  2. 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 ADA and/or WHO criteria (see Procedures Manual for definitions)

  3. At least one eye meets the study eye criteria.
  4. Fellow eye meets criteria.
  5. Able and willing to provide informed consent.
  6. Any candidate identified by a study investigator as being able to successfully tolerate a 3 month deferral of laser photocoagulation.

    Exclusion Criteria:

  7. Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
  8. Subjects in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
  9. Participation in an investigational trial within 30 days of NIR participation that involved treatment with any drug that has not received regulatory approval at the time of study entry.

    • Note: subjects cannot receive another investigational drug while participating in the study during the first 6 months...

  10. Major surgery within 28 days prior to participation or major surgery planned during the next 6 months.

    • Major surgery is defined as a surgical procedure that is more extensive than fine needle biopsy/aspiration, placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.

  11. Subject is expecting to move out of the area during the 6 months of the study.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846092

Locations
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
The New York Eye & Ear Infirmary
Investigators
Principal Investigator: Harry T Whelan, MD Medical College of Wisconsin
  More Information

Publications:

Responsible Party: Harry T Whelan, MD, PI, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00846092     History of Changes
Other Study ID Numbers: NIR for Diabetic Maculopathy
Study First Received: February 16, 2009
Last Updated: September 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Diabetic Retinopathy
Diabetic Macular Edema
NIR
Near-infrared Light Therapy

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 20, 2014