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Diabetic Macular Edema Clinical Trial

Official title: Safety Assessment and Therapeutic Effect of Non-damaging Patterned Scanning Laser Phototherapy in Patients With Diffuse Diabetic Macular Edema

Status Completed

Clinical Trial Summary

This trial seeks to prove that sub-lethal laser power levels are as effective and less damaging than traditional laser. Diabetic macular edema (DME) affects approximately 29% of diabetic patients with a disease duration of 20 or more years and is one of the most frequent causes of vision loss in this population. The Early Treatment Diabetic Retinopathy Study (ETDRS) demonstrated a significant benefit of laser photocoagulation for the treatment of clinically significant macular edema, reducing the incidence of vision loss by approximately 50% at 3 years' follow-up.

Clinical Trial Description

Sub-visible, non-damaging visible laser (532 nm) exposures of 100 ms in duration resulted in enhanced expression of heat shock proteins in the retina. To test clinical efficacy of sub-visible retinal therapy using ms-range exposures of visible lasers one needs first to establish proper titration methods necessary to assure on one hand the lack of tissue damage, and on the other hand sufficient hyperthermia to elicit cellular response. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

• NCT number: NCT01732614
• Study type: Interventional
• Source: Retinal Consultants of Arizona
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Completion date: December 2013