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NCT00846092 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Diabetic Macular Edema, sponsored by Medical College of Wisconsin.

Completed
Registry status
Phase 1
Development phase
4
Enrollment target
1
Study location

NCT00846092 is a Phase 1 study of Diabetic Macular Edema that has completed, run by Medical College of Wisconsin. The registered enrollment target is 4 participants, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00846092, a Phase 1 study of Diabetic Macular Edema, has completed, sponsored by Medical College of Wisconsin.

COMPLETED
Registry status
Phase 1
Development phase
4 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Diabetic Macular Edema

Interventions

  • DEVICE Warp 10 LED Device
  • DEVICE Near-infrared light (NIR)

Study Locations (1)

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2007-11
Est. Completion 2013-02
Phase Phase 1

Sponsor

Medical College of Wisconsin

447 total trials

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What the Registry Record Tells You About NCT00846092

The ClinicalTrials.gov registry entry for NCT00846092 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (100% lower). The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 2 interventions - of which Warp 10 LED Device is the first listed.

NCT00846092 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT00846092 about?

NCT00846092 is a clinical study titled "Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study". 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 ...

What is the current status of trial NCT00846092?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2007-11. Estimated completion is 2013-02.

What conditions does trial NCT00846092 study?

This clinical trial studies the following conditions: Diabetic Macular Edema.

What interventions are being tested in trial NCT00846092?

The interventions under investigation include: Warp 10 LED Device (DEVICE), Near-infrared light (NIR) (DEVICE).

Who is sponsoring clinical trial NCT00846092?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00846092 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.