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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Aflibercept injection with Micropulse laser.
Aflibercept injection with Sham Laser
Mississauga Retina Institute
Mississauga, Ontario, Canada
Toronto Retina Institute
Toronto, Ontario, Canada
Number of injections for each group
Number of intravitreal injections for each group
Time frame: 48 weeks
Changes in visual acuity
Changes in visual acuity from baseline to 24 adjusted for baseline
Time frame: 24 weeks
Changes in visual acuity
Changes in visual acuity from baseline to 48 weeks adjusted for baseline
Time frame: 48 weeks
Changes in OCT Central Macular Thickness and Volume
Measurement changes in central macular thickness at 24 weeks
Time frame: 24 weeks
Changes in OCT Central Macular Thickness and Volume
Measurement changes in central macular thickness at 48 weeks
Time frame: 48 weeks
Number of injections half way
Number of intravitreal injections of each group at 24 weeks
Time frame: 24 weeks
Proportion of eyes with 2 or 3 lines of visual gain or loss
Improvement or deterioration of vision of 2 or 3 lines at 24 weeks
Time frame: 24 weeks
Proportion of eyes with 2 or 3 lines of visual gain or loss
Improvement or deterioration of vision of 2 or 3 lines at 48 weeks
Time frame: 48 weeks
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Proportion of eyes that achieve 20/20 vision
Eyes that are able to see 20/20 at 24 weeks regardless of baseline
Time frame: 24 weeks
Proportion of eyes that achieve 20/20 vision
Eyes that are able to see 20/20 at 48 weeks regardless of baseline
Time frame: 48 weeks
Proportion of eyes that have PRP, vitreous hemorrhage, and vitrectomy.
Proportion of eyes in each study group that require panretinal photocoagulation, have a vitreous hemorrhage, or require a vitrectomy during the course of the study.
Time frame: 48 weeks
Proportion of eyes that had vision or OCT improvement
In patients with HbA1c ≤ 8% or separately measured in patients with HbA1C \> 8%
Time frame: 48 weeks