Clinical trial NCT00846092: Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Macular Edema
Keywords: Diabetic Retinopathy
Diabetic Macular Edema
NIR
Near-infrared Light Therapy
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: The New York Eye & Ear Infirmary
First posted: 2009-02-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Excess retinal thickness on OCT at 1 month, 3 months and 6 months. goal = reduce excess thickness by at least 50%
timeFrame: 1 month, 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Harry T Whelan, MD
role: PRINCIPAL_INVESTIGATOR
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