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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Young Hee Yoon, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01971190
First received: October 21, 2013
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Central Serous Chorioretinopathy
Drug: Intravitreal Aflibercept injection
Drug: Sham injection
Procedure: Half-fluence photodynamic therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intravitreal Aflibercept Injection for Subacute Central Serous Chorioretinopathy

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Changes of central subfield thickness from baseline with time [ Time Frame: at 1,2,3,4,5,6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of eyes achieving complete resolution of subretinal fluid [ Time Frame: at 6 month ] [ Designated as safety issue: No ]
  • Percentage of eyes achieving 20/20 vision [ Time Frame: at 6 month ] [ Designated as safety issue: No ]
  • Number of aflibercept injection to achieve a complete resolution [ Time Frame: at 6 month ] [ Designated as safety issue: No ]
  • Change in subfoveal choroidal thickness from baseline using EDI-OCT [ Time Frame: at 1,2,3,4,5,6 month ] [ Designated as safety issue: No ]
  • Adverse effect of intravitreal aflibercept (Eylea) injection [ Time Frame: upto 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: October 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham injection
Sham injection at baseline, at 1 month, and at 2 month
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)
Active Comparator: Intravitreal Aflibercept injection
2mg intravitreal Aflibercept(Eylea) injection at baseline, at 1 month, and at 2 month
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)
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)

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)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971190

Contacts
Contact: Young Hee Yoon, MD 821099783675 yhyoon@amc.seoul.kr
Contact: Dong Yoon Kim, MD 821085243484 umlover9@gmail.com

Locations
Korea, Republic of
Chungbuk national hospital Active, not recruiting
ChungJu, Korea, Republic of
Gangneung asan hospital Active, not recruiting
Gangneung, Korea, Republic of
Seoul national university Bundang Hospital Active, not recruiting
Ilsan, Korea, Republic of
Asan medical center Recruiting
Seoul, Korea, Republic of, 138736
Contact: Young Hee Yoon, MD    821099783675    yhyoon@amc.seoul.kr   
Contact: DongYoon Kim, MD    821085243484    umlover9@gmail.com   
Principal Investigator: Young Hee Yoon, MD         
Sub-Investigator: June-Gone Kim, MD         
Sub-Investigator: Joo Yong Lee, MD         
Sub-Investigator: Soo Guen Joe, MD         
Sub-Investigator: Hyung Seung Yang, MD         
Sub-Investigator: Yoon Jeon Kim, MD         
Sub-Investigator: Dong Yoon Kim, MD         
Samsung seoul hospital Active, not recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Young Hee Yoon, MD Asan Medical Center
  More Information

Publications:

Responsible Party: Young Hee Yoon, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01971190     History of Changes
Other Study ID Numbers: AFECT_001
Study First Received: October 21, 2013
Last Updated: October 24, 2013
Health Authority: South Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014