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

June 24, 2015 updated by: Young Hee Yoon, Asan Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • ChungJu, Korea, Republic of
        • Chungbuk national hospital
      • Gangneung, Korea, Republic of
        • GangNeung Asan Hospital
      • Ilsan, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 138736
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Samsung Seoul Hospital
      • Seoul, Korea, Republic of, 150-034
        • Kim's Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of central subfield thickness from baseline with time
Time Frame: at 1,2,3,4,5,6 month
at 1,2,3,4,5,6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of eyes achieving complete resolution of subretinal fluid
Time Frame: at 6 month
at 6 month
Percentage of eyes achieving 20/20 vision
Time Frame: at 6 month
at 6 month
Number of aflibercept injection to achieve a complete resolution
Time Frame: at 6 month
at 6 month
Change in subfoveal choroidal thickness from baseline using EDI-OCT
Time Frame: at 1,2,3,4,5,6 month
at 1,2,3,4,5,6 month
Adverse effect of intravitreal aflibercept (Eylea) injection
Time Frame: upto 6 month
upto 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimate)

October 29, 2013

Study Record Updates

Last Update Posted (Estimate)

June 25, 2015

Last Update Submitted That Met QC Criteria

June 24, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFECT_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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