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

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: NCT00846092
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : September 23, 2013
Sponsor:
Collaborator:
The New York Eye & Ear Infirmary
Information provided by (Responsible Party):
Harry T Whelan, MD, Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE February 16, 2009
First Posted Date  ICMJE February 18, 2009
Last Update Posted Date September 23, 2013
Study Start Date  ICMJE November 2007
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study
Official Title  ICMJE 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.
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

Interventions:
  • Device: Warp 10 LED Device
  • Device: Near-infrared light (NIR)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2013)
4
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2009)
20
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00846092
Other Study ID Numbers  ICMJE NIR for Diabetic Maculopathy
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Harry T Whelan, MD, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE The New York Eye & Ear Infirmary
Investigators  ICMJE
Principal Investigator: Harry T Whelan, MD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP