Diabetic Macular Edema Clinical Trial
Official title:
Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Patients With Persistent Diabetic Macular Edema Following Treatment With Ranibizumab: An Interventional Prospective Study
Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina.
The retina is like the film of a camera and is located in the back of the eye. This
condition can develop in diabetics where swelling results from leaking of fluid from the
blood vessels of the eye, into the center of the retina, the macula. If left untreated, this
can affect central.
The current standard treatment for diabetic macular edema includes medications injected
directly into the eye (intravitreal injections) and laser eye treatment. The drugs that are
injected directly into the eye are known as anti-VEGF agents which help to reduce the
leaking. This includes bevacizumab (Avastin®) and ranibizumab (Lucentis®).
However, some patients do not respond well to these anti-VEGF treatments and will be given
the option of switching to an another newer anti-VEGF medication, called aflibercept
(Eylea®) that is approved to treat DME. A recent large study has demonstrated that
aflibercept was as efficacious as other anti-VEGF therapies listed above and was even
superior in patients with worse vision (Diabetic Retinopathy Clinical Research Network,
Wells JA, Glassman AR, et al. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular
Edema. N Engl J Med. 2015:150218140025008-150218140025008).
The purpose of this study is to determine what factors affect the treatment response to
aflibercept (amount of swelling reduction) for patients with diabetic macular edema, who
were previously unresponsive to ranibizumab injections.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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