NCT01971190

Efficacy and Safety of Intravitreal Aflibercept Injection for Subacute Central Serous Chorioretinopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Central Serous Chorioretinopathy

Interventions

Type	Name	Description
DRUG	Intravitreal Aflibercept injection	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 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)
DRUG	Sham injection	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)
PROCEDURE	Half-fluence photodynamic therapy	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)

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2013-10-29
• Last updated: 2015-06-25

Locations

6 sites across 1 country: South Korea