NCT03143192

Treatment of Diabetic Macular Edema With Aflibercept and Micropulse Laser

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Keyvan Koushan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this pilot study is to investigate the safety and efficacy of micropulse (MP) macular laser in combination with intravitreal aflibercept for the treatment of centre-involved diabetic macular edema.

Detailed description

Diabetic macular edema (DME) is one of the major causes of visual decline among diabetic patients. Early Treatment of Diabetic Retinopathy Study has established focal/grid macular laser as the standard of treatment for clinically significant macular edema. More recently, intravitreal injections of anti-VEGF agents, either as monotherapy or in combination with focal/grid laser, have proven to be superior for the treatment of DME compared to laser alone. Micropulse (MP) macular laser involves applying the laser in a fraction of the time within very small pockets of energy. Unline traditional focal/grid macular laser, the micropulse method of delivery does not leave any visible burns on the retina. A recent release by the Diabetic Retinopathy Clinical Research Network has shown that deferring focal/grid laser and treating diabetic macular edema with only anti-VEGF may lead to better visual outcomes. Since MP laser does not have the undesired side effect of leaving laser scars on the macula, the study is to show that prompt MP laser in addition to anti-vegf injections may lead to better visual outcomes and/or decreased treatment burden without the undesired side effect of macular scarring.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Micropulse Laser	Aflibercept injection with Micropulse laser.
DEVICE	Sham Laser	Aflibercept injection with Sham Laser

Timeline

• Start date: 2017-03-08
• Primary completion: 2019-05-09
• Completion: 2019-05-09
• First posted: 2017-05-08
• Last updated: 2019-09-10

Locations

2 sites across 1 country: Canada