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COMPLETED Phase 1

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

NCT00846092 · View on ClinicalTrials.gov ↗

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

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

614 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00846092

The ClinicalTrials.gov registry entry for NCT00846092 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 614 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00846092 reports 1 study location spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00846092?

The interventions under investigation include: Warp 10 LED Device (DEVICE), Near-infrared light (NIR) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00846092?

This trial is sponsored by Medical College of Wisconsin, which has 614 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial