A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Experimental: Higher Dose Regimen 1
  Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.
• Experimental: Higher Dose Regimen 2
  Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.
• Active Comparator: Standard of care
  Aflibercept 2 mg is administered by standard treatment intervals, followed by adjustment of treatment intervals according to treatment response.

Geprüfte Regime

• Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose:
  Intravitreally (IVT) injection.
• Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg:
  Intravitreally (IVT) injection.
• Sham:
  Sham procedure will be given on visits when an active injection is not planned.
• Fluorescein:
  Fluorescein 100 mg/mL solution for injection is a dye that makes the retinal vessels visible during FA examinations, and as such, it will be used as an auxiliary medicinal product (AxMP) in this periodic ophthalmic examination. This medicine is for diagnostic use only. It is not used to treat any condition.

Quelle: ClinicalTrials.gov