Clinical Studies:


Summarized by Samir N. Patel, MD (Wills Eye Hospital)

Citations: Boyer DS, Faber D, Gupta S, Patel SS, Tabandeh H, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011 May;31(5):915-23.

Key Points

  • Intravitreal aflibercept is safe and effective for treatment of macular edema secondary to central retinal vein occlusion (CRVO)
  • Monthly aflibercept for 6 months resulted in improvement of macular edema, vision, and patient-reported visual function, as well as reduced neovascular complications compared to sham injections
  • Once transitioned to a PRN regimen with monthly monitoring (after 6 months of monthly treatment), eyes that received monthly aflibercept maintained these improvements at 1 year with a decreased injection burden. Eyes that received monthly sham injections had improvement in visual and anatomic outcomes after switching to PRN aflibercept.
  • Once transitioned to a PRN regimen with less frequent monitoring after 1 year (at least quarterly examinations), visual and anatomic gains during the first year of the study declined, indicating that less frequent monitoring may be insufficient to control the disease.
  • Objective:

    To evaluate safety and effectiveness of dexamethasone intravitreal implant (DEX implant, 0.7mg) in previously vitrectomized eyes of diabetic patients with diabetic macular edema (DME).


    Phase 2, open-label, multicenter study


    26 weeks


Major inclusion criteria:



Study population

Anatomic outcomes

Visual acuity end-points

Adverse Events