Clinical Trial: Efficacy and Safety of Intravitreal Aflibercept Injection for Subacute Central Serous Chorioretinopathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy and Safety of Intravitreal Aflibercept Injection for Subacute Central Serous Chorioretinopathy
Brief 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 aflibe
Detailed Summary:
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
- 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)
Sponsor: Asan Medical Center
Current Primary Outcome: Changes of central subfield thickness from baseline with time [ Time Frame: at 1,2,3,4,5,6 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of eyes achieving complete resolution of subretinal fluid [ Time Frame: at 6 month ]
- Percentage of eyes achieving 20/20 vision [ Time Frame: at 6 month ]
- Number of aflibercept injection to achieve a complete resolution [ Time Frame: at 6 month ]
- Change in subfoveal choroidal thickness from baseline using EDI-OCT [ Time Frame: at 1,2,3,4,5,6 month ]
- Adverse effect of intravitreal aflibercept (Eylea) injection [ Time Frame: upto 6 month ]
Original Secondary Outcome: Same as current
Information By: Asan Medical Center
Dates:
Date Received: October 21, 2013
Date Started: October 2013
Date Completion:
Last Updated: June 24, 2015
Last Verified: June 2015
