Diabetic Macular Edema Clinical Trial
Official title:
Dexamethasone Intravitreal Implant (0.7mg) for the Treatment of Persistent Diabetic Macular Edema Following Intravitreal Anti-Vascular Endothelial Growth Factor Therapy
Laser photocoagulation and intravitreal anti-vascular growth factor injections are commonly used treatment options for individuals with diabetic macular edema. However, some patients continue to experience persistent diabetic macular edema and poor vision despite continued laser and/or anti-vegf therapy. Recent clinical trials suggest that due to inflammatory mediators dexamethasone intravitreal implant (0.7mg) may be a good alternative therapy for individuals unresponsive to laser photocoagulation or intravitreal anti-vascular growth factor injections. The purpose of this research study is to compare the effectiveness of using a dexamethasone steroid implant versus monthly intravitreal anti-VEGF injections for research participants with persistent diabetic macular edema (DME).
Macular edema is a major cause of central vision loss in patients presenting with diabetic
retinopathy. Diabetic macular edema (DME) occurs when fluid leaks into the center of the
macula, the part of the eye where sharp, straight-ahead vision occurs. The fluid makes the
macula swell, blurring vision. Diabetic macular edema (DME) affects between 8% to 10% of 23.6
million diabetic individuals in the United States. The prevalence of diabetic macular edema
after 15 years of known diabetes is approximately 20% in patients with type 1 diabetes, 25%
in patients with type 2 diabetes who are taking insulin, and 14% in patients with type 2
diabetes who do not take insulin. Within two years of diagnosis, nearly half of individuals
with DME will lose 2 or more lines of visual acuity (the smallest line you can read on a
standardized vision chart held 20 feet away).
Diabetic macular edema is typically treated with laser and/or intravitreal injections of
drugs such as anti-VEGF agents. Anti-VEGF agents block a protein that slows the growth of the
abnormal blood vessels. Dexamethasone is a corticosteroid used to treat inflammation.
Dexamethasone implant is a steroid implant injected into the eye to treat swelling that may
occur when there is a blockage of certain blood vessels in your eyes. Both anti-VEGF agents
and dexamethasone implant are approved by the FDA to treat DME.
The purpose of this research study is to compare the effectiveness of using a dexamethasone
steroid implant versus monthly intravitreal anti-VEGF injections for research participants
with persistent diabetic macular edema (DME).
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