Clinical Studies:


Summarized by Kyle Kovacs, MD (Weill Cornell Medicine Department of Ophthalmology)


Six month results: Holz FG, Roider J, Ogura Y, et alVEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study. Br J Ophthalmol. 2013;97:278-284.

Twelve month results: Korobelnik JF, Holz FG, Roider J, Ogura Y, Simader C, Schmidt-Erfurth U, Lorenz K, Honda M, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal Aflibercept Injection for Macular Edema Resulting from Central Retinal Vein Occlusion: One-Year Results of the Phase 3 GALILEO Study. Ophthalmology. 2014 Jan;121(1):202-208.

Eighteen month results: Ogura Y, Roider J, Korobelnik JF, et al; GALILEO Study Group. Intravitreal aflibercept for macular edema secondary to central retinal vein occlusion: 18-month results of the phase 3 GALILEO study. Am J Ophthalmol. 2014;158(5):1032-1038.

Key Points

  • Primary Study: The GALILEO trial was a randomized, treatment-controlled trial that compared aflibercept 2mg monthly fixed dose versus sham injection q 4 weeks for 20 weeks (6 month primary outcomes)
  • There were two planned extensions to the study:

    • 6 months to 1 year- Comparing aflibercept q4 weeks PRN versus sham injection PRN q4 weeks from weeks 24 to 48
    • 1 year to 18 months- Both treatment arms began receiving aflibercept PRN q 8 weeks
  • There was a significant difference at 6 months in visual outcomes (letter gain more than 15 letters, 60.2% versus 22.1%) and decrease in central retinal thickness (CRT, -448.6μm versus -169.3μm) for patients treated with aflibercept 2mg monthly compared with sham.
  • Ocular adverse events were associated with injection procedure including pain (11.5%), increased intraocular pressure (9.6%), and conjunctival hemorrhage (8.7%)
  • These results were sustained with PRN treatment and extended intervals in the planned extension studies
  • Objective

    To study the efficacy, safety, and tolerability of aflibercept 2mg vs. sham monthly for macular edema secondary to central retinal vein occlusion (CRVO)


    Phase 3, multicenter, randomized, double-masked, sham-controlled trial


    6 months primary study, with planned 12 month and 18 month extension points



Randomized 3:2 to

(a) aflibercept 2mg injection fixed monthly

(b) sham injection fixed monthly

For extension studies, retreatment criteria for PRN groups:

RESULTS (6 months)

Study population



Study population

Visual acuity end-points

Anatomic end-points on OCT

Adverse events

Results (1 year planned extension)

Q4 weeks PRN dosing regimen for Aflibercept arm

Results (18 month planned extension)

Q8 weeks PRN aflibercept 2mg dosing regimen for BOTH arms