Dexamethasone Intravitreal Implant (0.7mg) for the Treatment of Persistent Diabetic Macular Edema Following Intravitreal Anti-Vascular Endothelial Growth Factor Therapy (DIME)

NCT02471651 Phase 4 COMPLETED Results posted

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).

Details

Lead sponsor	California Retina Consultants
Phase	Phase 4
Status	COMPLETED
Enrolment	40
Start date	2015-06
Completion	2018-10-24

Conditions

• Diabetic Macular Edema

Interventions

• Dexamethasone intravitreal implant (0.7 mg)
• Intravitreal anti-VEGF injection

Primary outcomes

• Mean Change in Central 1 mm Subfield Thickness Between Baseline and 9 Months — baseline and 9 months
  Mean change in central 1 mm sub-field thickness between baseline and 9 months as measured by Spectral Domain Optical Coherence Tomography (SDOCT).

Countries

United States