drugset / Trial / NCT02471651

Dexamethasone Intravitreal Implant for the Treatment of Persistent Diabetic Macular Edema

NCT02471651

Phase 4 Completed 40 enrolled California Retina Consultants Allergan · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2015-06
Primary completion
2018-10-24
Completion
2018-10-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aflibercept Protein / enzyme biologic Intravitreal
Comparator Bevacizumab Monoclonal antibody Intravitreal
Comparator Dexamethasone Small molecule 0.7 mg Intravitreal
Comparator Ranibizumab Monoclonal antibody Intravitreal