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

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Brief Title

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

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 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)
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Changes of central subfield thickness from baseline with time

Secondary Outcome

 Percentage of eyes achieving complete resolution of subretinal fluid

Condition

Central Serous Chorioretinopathy

Intervention

Intravitreal Aflibercept injection

Study Arms / Comparison Groups

 Sham injection
Description:  Sham injection at baseline, at 1 month, and at 2 month

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

43

Start Date

October 2013

Completion Date

May 2015

Primary Completion Date

April 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical diagnosis of idiopathic CSC.

          -  18 to 60 years old, woman and man.

          -  Subretinal fluid is found at OCT.

          -  Symptom duration is from 6 weeks to 4 months.

          -  Patient who agree to participate in the study.

        Exclusion Criteria:

          -  Patient who was treated previously for CSC

          -  Patient who has choroidal neovascularization or other macular disease

          -  Patient who has other ophthalmologic disease that may affect patient's vision.

          -  History of any intraocular surgery, except cataract extraction prior to 3 months

          -  Patient who has active intraocular inflammation or infection

          -  Patient who has uncontrolled glaucoma IOP was more than 25 mmHg in spite of
             anti-glaucoma medication Visual field defect which affect best corrected visual acuity

          -  Patient who has been used systemic or topical carbonic anhydrase inhibitor within 1
             month

          -  Cushing syndrome

          -  History of intravitreal steroid injection to study eye

          -  Patient who has been used or plan to use systemic drug which is toxic to crystalline
             lens, retina or optic nerve.

          -  Patient who has a known allergy to fluorescein or ICG

          -  Pregnant or breast-feeding woman

          -  Patient with contraindication to aflibercept Ocular or periocular infection Active
             severe intraocular inflammation Known hypersensitivity to aflibercept or to any of the
             excipients
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Young Hee Yoon, MD, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT01971190

Organization ID

AFECT_001


Responsible Party

Principal Investigator

Study Sponsor

Asan Medical Center


Study Sponsor

Young Hee Yoon, MD, Principal Investigator, Asan Medical Center


Verification Date

June 2015