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NCT02457975 · ClinicalTrials.gov registry record · Early Phase 1
Photobiomodulation for the Treatment of Diabetic Macular Edema
A Early Phase 1 study of Diabetic Retinopathy, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02457975 is a Early Phase 1 study of Diabetic Retinopathy that has completed, run by Medical College of Wisconsin. The registered enrollment target is 16 participants, below the 1,676-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02457975, a Early Phase 1 study of Diabetic Retinopathy, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The current application proposes to conduct a prospective, clinical trial in diabetic subjects with diabetic macular edema (DME) to evaluate the therapeutic efficacy of 670 nm photobiomodulation on validated clinical outcome measures and anatomical changes in central macula by optical coherence tomography (OCT) and other imaging modalities. A total of 30 diabetic patients with treatment-refractory clinically significant diabetic macular edema will be included in this study and randomized into two equal groups. One eye per participant will be included to avoid exposure of both eyes to the study intervention. If both eyes are eligible, the eye with worse visual acuity will become the study eye. One group will be treated with standard-of-care (intravitreal anti-VEGF agent) injections. The photobiomodulaton (PBM) intervention group will be treated with the standard-of-care intravitreal anti-VEGF (vascular endothelial growth factor) injections and 670 nm PBM in one eye. Baseline functional and anatomic assessments will be made and anti-VEGF therapy will be administered as determined by the treating Ophthalmologist.
Conditions Studied
Interventions
- DEVICE 670nm PBM
- DRUG intravitreous VEGF-inhibitors
Study Locations (1)
Wisconsin
- Medical College of Wisconsin Froedert Hospital - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-06 |
| Est. Completion | 2019-08-30 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02457975
The ClinicalTrials.gov registry entry for NCT02457975 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,676-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (99% 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 Retinopathy appearing as the primary indexed condition, and to 2 interventions - of which 670nm PBM is the first listed.
NCT02457975 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT02457975 about?
NCT02457975 is a clinical study titled "Photobiomodulation for the Treatment of Diabetic Macular Edema". The current application proposes to conduct a prospective, clinical trial in diabetic subjects with diabetic macular edema (DME) to evaluate the therapeutic efficacy of 670 nm photobiomodulation on validated clinical outcome measures and anatomical changes in central macula by optical coherence tomo...
What is the current status of trial NCT02457975?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2015-06. Estimated completion is 2019-08-30.
What conditions does trial NCT02457975 study?
This clinical trial studies the following conditions: Diabetic Retinopathy.
What interventions are being tested in trial NCT02457975?
The interventions under investigation include: 670nm PBM (DEVICE), intravitreous VEGF-inhibitors (DRUG).
Who is sponsoring clinical trial NCT02457975?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02457975 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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