Efficacy and Safety of Intravitreal Aflibercept Injection for Subacute Central Serous Chorioretinopathy
Condition: Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      Central serous chorioretinopathy (CSC) is a self-limiting disease that usually associated
      with good visual prognosis. In some cases, however, CSC may persist and result in permanent
      retinal or retinal pigment epithelium (RPE) damage. Therefore, if the disease is persistent
      beyond the acute phase, an active treatment should be considered to prevent an irreversible
      damage to retinal function.

      The pathophysiology of CSC is associated with abnormal choroidal circulation. Indocyanine
      green angiography (ICGA) has revealed dilated and congested choroidal vessel and leakage into
      the extracellular space that appears as area of hyperfluorescence seen in middle and late
      phase in eyes with CSC.

      A goal of treatment has been focused on reducing choroidal hyperpermeability. Currently,
      photodynamic therapy with verteporfin (PDT) and intravitreal anti-VEGF (vascular endothelial
      growth factor)antibody injection are being tried in order to treat chronic CSC. PDT reduces
      choroidal hyperpermeability by inducing hypoperfusion of the choriocapillaris in the short
      term and choroidal vascular remodeling over time. Intravitreal anti-VEGF injection for the
      treatment of CSC also effectively reduces choroidal hyperpermeability by blocking vascular
      leakage. Both methods have shown to be effective with good functional outcome for treating
      chronic CSC in many reports, but until now there is no established standard treatment
      protocol for chronic CSC.

      Bevacizumab (Avastin) and ranibizumab (Lucentis) have been used widely as anti-VEGF
      therapeutic agent for the treatment of age related macular generation (AMD) and macular edema
      of various reasons. A newly developed anti-VEGF drug, aflibercept (Eylea○R), shows higher
      affinity to VEGF and has a longer duration of effect in the vitreous.FDA approved aflibercept
      to treat wet type AMD and macular edema due to central retinal vein occlusion.

      Until now, no study has been reported on the efficacy and safety of aflibercept for treating
      CSC. The aim of this study is to evaluate the efficacy and safety of intravitreal aflibercept
      injection for the treatment of idiopathic CSC
    

Detailed description: 
      Single-center Double blind randomized Phase 2 interventional parallel study.

      Group A : 2mg intravitreal Aflibercept(Eylea) injection at baseline, at 1 month, and at 2
      month Group B : Sham injection at baseline, at 1 month, and at 2 month

      At 3 month, 4 month, 5 month, and 6 month, PRN treatment of aflibercept injection or
      half-fluence photodynamic therapy may be done, if one of following conditions is fulfilled.

      The PRN treatment method was decided by investigator's discretion.

      Of patient who had persistent intra- or subretina fluid on SD-OCT

        1. Central subfield thickness is not decreased to more than 50 micrometer compared with
           baseline central subfield thickness

        2. Best-corrected ETDRS letter score dose not increased more than 5 letters than baseline
           (because of the persistent CSC).

        3. Central subfield thickness is thicker than the previous exam

        4. BCVA letter score is worse than the previous exam (because of the persistent CSC)
    

Intervention name(s): Intravitreal Aflibercept injection; Sham injection; Half-fluence photodynamic therapy
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): 2mg intravitreal Aflibercept(Eylea) injection at baseline, at 1 month, and at 2 month.
At 3 month, 4 month, 5 month, and 6 month, PRN treatment of aflibercept injection or half-fluence photodynamic therapy may be done, if one of following conditions is fulfilled.
The PRN treatment method was decided by investigator's discretion.
Of patient who had persistent intra- or subretina fluid on SD-OCT
Central subfield thickness is not decreased to more than 50 micrometer compared with baseline central subfield thickness
Best-corrected ETDRS letter score dose not increased more than 5 letters than baseline (because of the persistent CSC).
Central subfield thickness is thicker than the previous exam
BCVA letter score is worse than the previous exam (because of the persistent CSC); Sham injection at baseline, at 1 month, and at 2 month.
At 3 month, 4 month, 5 month, and 6 month, PRN treatment of aflibercept injection or half-fluence photodynamic therapy may be done, if one of following conditions is fulfilled.
The PRN treatment method was decided by investigator's discretion.
Of patient who had persistent intra- or subretina fluid on SD-OCT
Central subfield thickness is not decreased to more than 50 micrometer compared with baseline central subfield thickness
Best-corrected ETDRS letter score dose not increased more than 5 letters than baseline (because of the persistent CSC).
Central subfield thickness is thicker than the previous exam
BCVA letter score is worse than the previous exam (because of the persistent CSC); At 3 month, 4 month, 5 month, and 6 month, PRN treatment of aflibercept injection or half-fluence photodynamic therapy may be done, if one of following conditions is fulfilled.
The PRN treatment method was decided by investigator's discretion.
Of patient who had persistent intra- or subretina fluid on SD-OCT
Central subfield thickness is not decreased to more than 50 micrometer compared with baseline central subfield thickness
Best-corrected ETDRS letter score dose not increased more than 5 letters than baseline (because of the persistent CSC).
Central subfield thickness is thicker than the previous exam
BCVA letter score is worse than the previous exam (because of the persistent CSC)
Intervention MeSH terms: Aflibercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment