Central Serous ChorioretinopathyPhase 2NCT01971190
Efficacy and Safety of Intravitreal Aflibercept Injection for Subacute Central Serous Chorioretinopathy
A Phase 2 study testing Intravitreal Aflibercept injection and Half-fluence photodynamic therapy in people with Central Serous Chorioretinopathy, run by Asan Medical Center at 6 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- Intravitreal Aflibercept injection and Half-fluence photodynamic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Oct 2013to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Chungbuk national hospital
Chungju
Gangneung asan hospital
Gangneung
Seoul national university Bundang Hospital
Ilsan
Asan medical center
Seoul, 138736
Kim's Eye Hospital
Seoul, 150-034
Samsung seoul hospital
Seoul
About this study
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.
Read more
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
Read the 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
- 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)
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- Intravitreal Aflibercept injection, Sham injection, Half-fluence photodynamic therapy
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Aflibercept injectionDrug
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
- 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)
Sham injectionDrug
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)
Half-fluence photodynamic therapyProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Sham injection | Sham comparator | Sham injection at baseline, at 1 month, and at 2 month Receives: Drug: Sham injection; Procedure: Half-fluence photodynamic therapy |
| Intravitreal Aflibercept injection | Active comparator | 2mg intravitreal Aflibercept(Eylea) injection at baseline, at 1 month, and at 2 month Receives: Drug: Intravitreal Aflibercept injection; Procedure: Half-fluence photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of central subfield thickness from baseline with time
Measured: at 1,2,3,4,5,6 month
Secondary outcomes (5)
Percentage of eyes achieving complete resolution of subretinal fluid
Measured: at 6 month
Percentage of eyes achieving 20/20 vision
Measured: at 6 month
Number of aflibercept injection to achieve a complete resolution
Measured: at 6 month
Change in subfoveal choroidal thickness from baseline using EDI-OCT
Measured: at 1,2,3,4,5,6 month
Adverse effect of intravitreal aflibercept (Eylea) injection
Measured: upto 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Hee Yoon, Asan Medical Center
- Investigators
- Young Hee Yoon, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971190
- Sponsor's protocol ID
- AFECT_001
- Status last verified
- Jun 2015
- First submitted
- 21 Oct 2013
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dohrmann J, Lommatzsch A, Spital G, Pauleikhoff D. [Pathogenesis of central serous chorioretinopathy: angiographic and electrophysiological studies]. Ophthalmologe. 2001 Nov;98(11):1069-73. doi: 10.1007/s003470170027. German.
PubMed 11729739Wong R, Chopdar A, Brown M. Five to 15 year follow-up of resolved idiopathic central serous chorioretinopathy. Eye (Lond). 2004 Mar;18(3):262-8. doi: 10.1038/sj.eye.6700637.
PubMed 15004575Spaide RF, Hall L, Haas A, Campeas L, Yannuzzi LA, Fisher YL, Guyer DR, Slakter JS, Sorenson JA, Orlock DA. Indocyanine green videoangiography of older patients with central serous chorioretinopathy. Retina. 1996;16(3):203-13. doi: 10.1097/00006982-199616030-00004.
PubMed 8789858Bae SH, Heo JW, Kim C, Kim TW, Lee JY, Song SJ, Park TK, Moon SW, Chung H. A randomized pilot study of low-fluence photodynamic therapy versus intravitreal ranibizumab for chronic central serous chorioretinopathy. Am J Ophthalmol. 2011 Nov;152(5):784-92.e2. doi: 10.1016/j.ajo.2011.04.008. Epub 2011 Jul 13.
PubMed 21742303Lee JY, Chae JB, Yang SJ, Kim JG, Yoon YH. Intravitreal bevacizumab versus the conventional protocol of photodynamic therapy for treatment of chronic central serous chorioretinopathy. Acta Ophthalmol. 2011 May;89(3):e293-4. doi: 10.1111/j.1755-3768.2009.01835.x. No abstract available.
PubMed 20346078Lim JW, Kim MU. The efficacy of intravitreal bevacizumab for idiopathic central serous chorioretinopathy. Graefes Arch Clin Exp Ophthalmol. 2011 Jul;249(7):969-74. doi: 10.1007/s00417-010-1581-9. Epub 2010 Dec 8.
PubMed 21140161Semeraro F, Romano MR, Danzi P, Morescalchi F, Costagliola C. Intravitreal bevacizumab versus low-fluence photodynamic therapy for treatment of chronic central serous chorioretinopathy. Jpn J Ophthalmol. 2012 Nov;56(6):608-12. doi: 10.1007/s10384-012-0162-3. Epub 2012 Aug 23.
PubMed 22915299Browning DJ, Kaiser PK, Rosenfeld PJ, Stewart MW. Aflibercept for age-related macular degeneration: a game-changer or quiet addition? Am J Ophthalmol. 2012 Aug;154(2):222-6. doi: 10.1016/j.ajo.2012.04.020.
PubMed 22813448Frampton JE. Aflibercept for intravitreal injection: in neovascular age-related macular degeneration. Drugs Aging. 2012 Oct;29(10):839-46. doi: 10.1007/s40266-012-0015-2.
PubMed 23038609Holash J, Davis S, Papadopoulos N, Croll SD, Ho L, Russell M, Boland P, Leidich R, Hylton D, Burova E, Ioffe E, Huang T, Radziejewski C, Bailey K, Fandl JP, Daly T, Wiegand SJ, Yancopoulos GD, Rudge JS. VEGF-Trap: a VEGF blocker with potent antitumor effects. Proc Natl Acad Sci U S A. 2002 Aug 20;99(17):11393-8. doi: 10.1073/pnas.172398299. Epub 2002 Aug 12.
PubMed 12177445Brown DM, Heier JS, Clark WL, Boyer DS, Vitti R, Berliner AJ, Zeitz O, Sandbrink R, Zhu X, Haller JA. Intravitreal aflibercept injection for macular edema secondary to central retinal vein occlusion: 1-year results from the phase 3 COPERNICUS study. Am J Ophthalmol. 2013 Mar;155(3):429-437.e7. doi: 10.1016/j.ajo.2012.09.026. Epub 2012 Dec 4.
PubMed 23218699Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48. doi: 10.1016/j.ophtha.2012.09.006. Epub 2012 Oct 17.
PubMed 23084240Boyer D, Heier J, Brown DM, Clark WL, Vitti R, Berliner AJ, Groetzbach G, Zeitz O, Sandbrink R, Zhu X, Beckmann K, Haller JA. Vascular endothelial growth factor Trap-Eye for macular edema secondary to central retinal vein occlusion: six-month results of the phase 3 COPERNICUS study. Ophthalmology. 2012 May;119(5):1024-32. doi: 10.1016/j.ophtha.2012.01.042. Epub 2012 Mar 21.
PubMed 22440275Do DV, Nguyen QD, Boyer D, Schmidt-Erfurth U, Brown DM, Vitti R, Berliner AJ, Gao B, Zeitz O, Ruckert R, Schmelter T, Sandbrink R, Heier JS; da Vinci Study Group. One-year outcomes of the da Vinci Study of VEGF Trap-Eye in eyes with diabetic macular edema. Ophthalmology. 2012 Aug;119(8):1658-65. doi: 10.1016/j.ophtha.2012.02.010. Epub 2012 Apr 24.
PubMed 22537617Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.
PubMed 40522203
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intravitreal Aflibercept Injection for Subacute Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT01971190
- Acronym / sponsor ID
- AFECT_001
- Conditions
- Central Serous Chorioretinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham injection | Sham comparator | Drug: Sham injection, Procedure: Half-fluence photodynamic therapySham injection at baseline, at 1 month, and at 2 month |
| Intravitreal Aflibercept injection | Active comparator | Drug: Intravitreal Aflibercept injection, Procedure: Half-fluence photodynamic therapy2mg intravitreal Aflibercept(Eylea) injection at baseline, at 1 month, and at 2 month |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal Aflibercept injection2mg 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 | Intravitreal Aflibercept injection |
| Sham injectionSham 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 |
| Half-fluence photodynamic therapyAt 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 or surgery | Intravitreal Aflibercept injection, Sham injection |
Primary outcome
Changes of central subfield thickness from baseline with time
Time frame: at 1,2,3,4,5,6 month
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Background: PubMed 11729739Dohrmann J, Lommatzsch A, Spital G, Pauleikhoff D. [Pathogenesis of central serous chorioretinopathy: angiographic and electrophysiological studies]. Ophthalmologe. 2001 Nov;98(11):1069-73. doi: 10.1007/s003470170027. German.
- Background: PubMed 15004575Wong R, Chopdar A, Brown M. Five to 15 year follow-up of resolved idiopathic central serous chorioretinopathy. Eye (Lond). 2004 Mar;18(3):262-8. doi: 10.1038/sj.eye.6700637.
- Background: PubMed 8789858Spaide RF, Hall L, Haas A, Campeas L, Yannuzzi LA, Fisher YL, Guyer DR, Slakter JS, Sorenson JA, Orlock DA. Indocyanine green videoangiography of older patients with central serous chorioretinopathy. Retina. 1996;16(3):203-13. doi: 10.1097/00006982-199616030-00004.
- Background: PubMed 21742303Bae SH, Heo JW, Kim C, Kim TW, Lee JY, Song SJ, Park TK, Moon SW, Chung H. A randomized pilot study of low-fluence photodynamic therapy versus intravitreal ranibizumab for chronic central serous chorioretinopathy. Am J Ophthalmol. 2011 Nov;152(5):784-92.e2. doi: 10.1016/j.ajo.2011.04.008. Epub 2011 Jul 13.
- Background: PubMed 20346078Lee JY, Chae JB, Yang SJ, Kim JG, Yoon YH. Intravitreal bevacizumab versus the conventional protocol of photodynamic therapy for treatment of chronic central serous chorioretinopathy. Acta Ophthalmol. 2011 May;89(3):e293-4. doi: 10.1111/j.1755-3768.2009.01835.x. No abstract available.
- Background: PubMed 21140161Lim JW, Kim MU. The efficacy of intravitreal bevacizumab for idiopathic central serous chorioretinopathy. Graefes Arch Clin Exp Ophthalmol. 2011 Jul;249(7):969-74. doi: 10.1007/s00417-010-1581-9. Epub 2010 Dec 8.
- Background: PubMed 22915299Semeraro F, Romano MR, Danzi P, Morescalchi F, Costagliola C. Intravitreal bevacizumab versus low-fluence photodynamic therapy for treatment of chronic central serous chorioretinopathy. Jpn J Ophthalmol. 2012 Nov;56(6):608-12. doi: 10.1007/s10384-012-0162-3. Epub 2012 Aug 23.
- Background: PubMed 22813448Browning DJ, Kaiser PK, Rosenfeld PJ, Stewart MW. Aflibercept for age-related macular degeneration: a game-changer or quiet addition? Am J Ophthalmol. 2012 Aug;154(2):222-6. doi: 10.1016/j.ajo.2012.04.020.
- Background: PubMed 23038609Frampton JE. Aflibercept for intravitreal injection: in neovascular age-related macular degeneration. Drugs Aging. 2012 Oct;29(10):839-46. doi: 10.1007/s40266-012-0015-2.
- Background: PubMed 12177445Holash J, Davis S, Papadopoulos N, Croll SD, Ho L, Russell M, Boland P, Leidich R, Hylton D, Burova E, Ioffe E, Huang T, Radziejewski C, Bailey K, Fandl JP, Daly T, Wiegand SJ, Yancopoulos GD, Rudge JS. VEGF-Trap: a VEGF blocker with potent antitumor effects. Proc Natl Acad Sci U S A. 2002 Aug 20;99(17):11393-8. doi: 10.1073/pnas.172398299. Epub 2002 Aug 12.
- Background: PubMed 23218699Brown DM, Heier JS, Clark WL, Boyer DS, Vitti R, Berliner AJ, Zeitz O, Sandbrink R, Zhu X, Haller JA. Intravitreal aflibercept injection for macular edema secondary to central retinal vein occlusion: 1-year results from the phase 3 COPERNICUS study. Am J Ophthalmol. 2013 Mar;155(3):429-437.e7. doi: 10.1016/j.ajo.2012.09.026. Epub 2012 Dec 4.
- Background: PubMed 23084240Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48. doi: 10.1016/j.ophtha.2012.09.006. Epub 2012 Oct 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Hee Yoon, MD principal investigator
Asan Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravitreal Aflibercept injection and Half-fluence photodynamic therapy in people with Central Serous Chorioretinopathy, run by Asan Medical Center at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of central subfield thickness from baseline with time (time frame: at 1,2,3,4,5,6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01971190, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.