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A Randomized Trial of Photobiomodulation Therapy for Center-Involved Diabetic Macular Edema with Good Visual Acuity
Judy E Kim1, Adam R Glassman2, Kristin Josic2
1Medical College of Wisconsin, Milwaukee, WI.
Ophthalmology. Retina
|October 10, 2021
Summary
Photobiomodulation (PBM) therapy did not improve central subfield thickness in patients with diabetic macular edema and good vision. The treatment was safe but ineffective for this condition.
Area of Science:
- Ophthalmology
- Medical Devices
- Diabetic Retinopathy
Background:
- Diabetic macular edema (DME) is a leading cause of vision loss in diabetic patients.
- Center-involved DME (CI-DME) with good visual acuity (VA) presents a challenge for treatment.
- Photobiomodulation (PBM) is an emerging therapy with potential applications in retinal diseases.
Purpose of the Study:
- To evaluate the efficacy of a PBM device compared to placebo for improving central subfield thickness (CST) in eyes with CI-DME and good vision.
- To assess the safety and tolerability of PBM therapy in this patient population.
Main Methods:
- A Phase 2, randomized clinical trial was conducted with 135 participants.
- Participants with CI-DME and VA 20/25 or better were randomized to receive either PBM or a placebo device.
- Treatment involved a 670-nm light-emitting eye patch applied twice daily for 4 months.
Main Results:
- No significant difference in CST change was observed between the PBM and placebo groups at 4 months (mean difference: -2 μm; P=0.84).
- The prevalence of CI-DME remained similar between groups at 4 months (90% vs 86%; P=0.63).
- Visual acuity changes were comparable between groups, and PBM was found to be safe and well-tolerated with minimal adverse events.
Conclusions:
- PBM therapy, as administered in this study, did not demonstrate effectiveness in reducing CST for CI-DME in eyes with good vision.
- The PBM device was safe and well-tolerated, suggesting potential for future research in different patient subgroups or with modified parameters.
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