Back to results

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

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Warp 10 LED Device

Near-infrared light (NIR)

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Retinopathy, Diabetic Macular Edema, NIR, Near-infrared Light Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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)
At least one eye meets the study eye criteria.
Fellow eye meets criteria.
Able and willing to provide informed consent.
Any candidate identified by a study investigator as being able to successfully tolerate a 3 month deferral of laser photocoagulation.
Exclusion Criteria:
Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
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.
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...
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.
Subject is expecting to move out of the area during the 6 months of the study.

Sites / Locations

Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device

Arm Description

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.

Outcomes

Primary Outcome Measures

Excess retinal thickness on OCT at 1 month, 3 months and 6 months. goal = reduce excess thickness by at least 50%

Secondary Outcome Measures

Full Information

NCT ID

NCT00846092

First Posted

February 16, 2009

Last Updated

September 20, 2013

Sponsor

Medical College of Wisconsin

Collaborators

The New York Eye & Ear Infirmary

1. Study Identification

Unique Protocol Identification Number

NCT00846092

Brief Title

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

Acronym

NIR

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

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical College of Wisconsin

Collaborators

The New York Eye & Ear Infirmary

4. Oversight

Data Monitoring Committee

5. Study Description

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 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. To assess safety of short term near-infrared light therapy in eyes with diabetic macular edema.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

Keywords

Diabetic Retinopathy, Diabetic Macular Edema, NIR, Near-infrared Light Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Device

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Warp 10 LED Device

Other Intervention Name(s)

Warp 10

Intervention Description

Study Subjects will take the Warp 10 (LED) home and treat twice per day for three months

Intervention Type

Device

Intervention Name(s)

Near-infrared light (NIR)

Other Intervention Name(s)

Warp 10 LED's

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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) At least one eye meets the study eye criteria. Fellow eye meets criteria. Able and willing to provide informed consent. Any candidate identified by a study investigator as being able to successfully tolerate a 3 month deferral of laser photocoagulation. Exclusion Criteria: Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. 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. 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... 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. Subject is expecting to move out of the area during the 6 months of the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harry T Whelan, MD

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

6521986

Citation

Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. IV. Diabetic macular edema. Ophthalmology. 1984 Dec;91(12):1464-74. doi: 10.1016/s0161-6420(84)34102-1.

Results Reference

background

PubMed Identifier

8008348

Citation

Moss SE, Klein R, Klein BE. Ten-year incidence of visual loss in a diabetic population. Ophthalmology. 1994 Jun;101(6):1061-70. doi: 10.1016/s0161-6420(94)31217-6.

Results Reference

background

PubMed Identifier

9627648

Citation

Moss SE, Klein R, Klein BE. The 14-year incidence of visual loss in a diabetic population. Ophthalmology. 1998 Jun;105(6):998-1003. doi: 10.1016/S0161-6420(98)96025-0.

Results Reference

background

PubMed Identifier

2062512

Citation

Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):766-85.

Results Reference

background

PubMed Identifier

8366922

Citation

Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

Results Reference

background

PubMed Identifier

9742976

Citation

Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum In: Lancet 1999 Aug 14;354(9178):602.

Results Reference

background

PubMed Identifier

10666428

Citation

Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group; Lachin JM, Genuth S, Cleary P, Davis MD, Nathan DM. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. N Engl J Med. 2000 Feb 10;342(6):381-9. doi: 10.1056/NEJM200002103420603. Erratum In: N Engl J Med 2000 May 4;342(18):1376.

Results Reference

background

PubMed Identifier

11776448

Citation

Whelan HT, Smits RL Jr, Buchman EV, Whelan NT, Turner SG, Margolis DA, Cevenini V, Stinson H, Ignatius R, Martin T, Cwiklinski J, Philippi AF, Graf WR, Hodgson B, Gould L, Kane M, Chen G, Caviness J. Effect of NASA light-emitting diode irradiation on wound healing. J Clin Laser Med Surg. 2001 Dec;19(6):305-14. doi: 10.1089/104454701753342758.

Results Reference

background

PubMed Identifier

7696489

Citation

Beauvoit B, Kitai T, Chance B. Contribution of the mitochondrial compartment to the optical properties of the rat liver: a theoretical and practical approach. Biophys J. 1994 Dec;67(6):2501-10. doi: 10.1016/S0006-3495(94)80740-4.

Results Reference

background

PubMed Identifier

10365442

Citation

Karu T. Primary and secondary mechanisms of action of visible to near-IR radiation on cells. J Photochem Photobiol B. 1999 Mar;49(1):1-17. doi: 10.1016/S1011-1344(98)00219-X.

Results Reference

background

PubMed Identifier

15557336

Citation

Wong-Riley MT, Liang HL, Eells JT, Chance B, Henry MM, Buchmann E, Kane M, Whelan HT. Photobiomodulation directly benefits primary neurons functionally inactivated by toxins: role of cytochrome c oxidase. J Biol Chem. 2005 Feb 11;280(6):4761-71. doi: 10.1074/jbc.M409650200. Epub 2004 Nov 22.

Results Reference

background

PubMed Identifier

16464535

Citation

Liang HL, Whelan HT, Eells JT, Meng H, Buchmann E, Lerch-Gaggl A, Wong-Riley M. Photobiomodulation partially rescues visual cortical neurons from cyanide-induced apoptosis. Neuroscience. 2006 May 12;139(2):639-49. doi: 10.1016/j.neuroscience.2005.12.047. Epub 2006 Feb 7.

Results Reference

background

PubMed Identifier

16120414

Citation

Eells JT, Wong-Riley MT, VerHoeve J, Henry M, Buchman EV, Kane MP, Gould LJ, Das R, Jett M, Hodgson BD, Margolis D, Whelan HT. Mitochondrial signal transduction in accelerated wound and retinal healing by near-infrared light therapy. Mitochondrion. 2004 Sep;4(5-6):559-67. doi: 10.1016/j.mito.2004.07.033.

Results Reference

background

PubMed Identifier

12513918

Citation

Whelan HT, Connelly JF, Hodgson BD, Barbeau L, Post AC, Bullard G, Buchmann EV, Kane M, Whelan NT, Warwick A, Margolis D. NASA light-emitting diodes for the prevention of oral mucositis in pediatric bone marrow transplant patients. J Clin Laser Med Surg. 2002 Dec;20(6):319-24. doi: 10.1089/104454702320901107.

Results Reference

background

PubMed Identifier

12737646

Citation

Whelan HT, Buchmann EV, Dhokalia A, Kane MP, Whelan NT, Wong-Riley MT, Eells JT, Gould LJ, Hammamieh R, Das R, Jett M. Effect of NASA light-emitting diode irradiation on molecular changes for wound healing in diabetic mice. J Clin Laser Med Surg. 2003 Apr;21(2):67-74. doi: 10.1089/104454703765035484.

Results Reference

background

PubMed Identifier

11568632

Citation

Wong-Riley MT, Bai X, Buchmann E, Whelan HT. Light-emitting diode treatment reverses the effect of TTX on cytochrome oxidase in neurons. Neuroreport. 2001 Oct 8;12(14):3033-7. doi: 10.1097/00001756-200110080-00011.

Results Reference

background

PubMed Identifier

12626762

Citation

Eells JT, Henry MM, Summerfelt P, Wong-Riley MT, Buchmann EV, Kane M, Whelan NT, Whelan HT. Therapeutic photobiomodulation for methanol-induced retinal toxicity. Proc Natl Acad Sci U S A. 2003 Mar 18;100(6):3439-44. doi: 10.1073/pnas.0534746100. Epub 2003 Mar 7.

Results Reference

background

PubMed Identifier

16565397

Citation

Kowluru RA, Atasi L, Ho YS. Role of mitochondrial superoxide dismutase in the development of diabetic retinopathy. Invest Ophthalmol Vis Sci. 2006 Apr;47(4):1594-9. doi: 10.1167/iovs.05-1276.

Results Reference

background

PubMed Identifier

17015165

Citation

Kowluru RA, Kowluru V, Xiong Y, Ho YS. Overexpression of mitochondrial superoxide dismutase in mice protects the retina from diabetes-induced oxidative stress. Free Radic Biol Med. 2006 Oct 15;41(8):1191-6. doi: 10.1016/j.freeradbiomed.2006.01.012. Epub 2006 Feb 6.

Results Reference

background

PubMed Identifier

15504974

Citation

Nyengaard JR, Ido Y, Kilo C, Williamson JR. Interactions between hyperglycemia and hypoxia: implications for diabetic retinopathy. Diabetes. 2004 Nov;53(11):2931-8. doi: 10.2337/diabetes.53.11.2931.

Results Reference

background

PubMed Identifier

11287819

Citation

Obrosova IG, Stevens MJ, Lang HJ. Diabetes-induced changes in retinal NAD-redox status: pharmacological modulation and implications for pathogenesis of diabetic retinopathy. Pharmacology. 2001;62(3):172-80. doi: 10.1159/000056091.

Results Reference

background

PubMed Identifier

9893588

Citation

Weinberger D, Axer-Siegel R, Landau D, Yassur Y. Retinal thickness variation in the diabetic patient measured by the retinal thickness analyser. Br J Ophthalmol. 1998 Sep;82(9):1003-6. doi: 10.1136/bjo.82.9.1003.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs