Diabetic Macular Edema Clinical Trial
Official title:
Phase III Multi Center Study Study of the Effects of Selective Retinal Photocoagulation for the Treatment of Diabetic Macular Edema
The population of people suffering from diabetes is rapidly increasing, from an estimated
110 million in 1994 to 221 million in 2010. Diabetic macular edema is the most common reason
for reduction in visual acuity in diabetic patients.
The standard care for diabetic macular edema is focal and /or grid retinal photocoagulation.
During photocoagulation, small laser burns are applied to the retina, the sensory tissue
that lines the back of the eye. Studies have shown that photocoagulation of clinically
significant diabetic macular edema substantially reduces the risk of visual loss, increase
the chance of visual improvement and decrease the frequency of persistent macular edema.
However, it remains unknown whether the destruction of sensory layer of the retina during
photocoagulation that may cause visual field defects is necessary for successful treatment
or is just an unwanted and unnecessary side effect.
Based on these concept, a photocoagulation technique was developed to treat the retina
selectively (SRT - Selective retinal therapy), with minimal or no damage to the sensory
layers. While the treatment is very similar to regular photocoagulation, the SRT laser uses
much lower energy and very short pulses. As a result, treatment does not result in visible
burns to the retina and previous studies have shown that the sensory layer remains intact.
The aim of this study is to determine the effect of SRT on the resolution of the edema.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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