Chronic Central Serous ChorioretinopathyPhase 1/2NCT01325181
Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
A Phase 1/2 study testing Verteporfin and ranibizumab in people with Chronic Central Serous Chorioretinopathy, run by Jang Won Heo at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab injection versus low-fluence PDT in the treatment of chronic CSC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Central Serous Chorioretinopathy
- What is being tested?
- Verteporfin and ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2009to Sep 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- best-corrected visual acuity (BCVA) between 0.0 and 1.0 logarithm of the minimal angle of resolution (logMAR)
- presence of subfoveal fluid persisting for 3 months or more on optical coherence tomography (OCT)
- presence of leakage and multifocal/diffuse RPE decompensation on fluorescein angiography (FA)
- choroidal vascular hyperpermeability and abnormal dilation of choroidal vasculature on indocyanine angiography (ICGA)
Who cannot join
- previous treatment, such as laser photocoagulation, PDT, intravitreal injection of steroid or anti-VEGF agent
- evidence of choroidal neovascularization
- any other ocular diseases that could affect visual acuity
- systemic steroid treatment in the previous 12 months
- media opacity such as cataract that could interfere with adequate acquisition of OCT, FA and ICGA images
Trial locations and contacts
1 site in 1 country.
South Korea1 site
• Department of Ophthalmology, Seoul National University College of Medicine
Seoul, Gyeonggi-do
About this study
Official title: Prospective Study on the Efficacy and Safety of Intravitreal Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab injection versus low-fluence PDT in the treatment of chronic CSC.
Read the detailed description
Central serous chorioretinopathy (CSC) is characterized by serous detachment of the neurosensory retina. The pathophysiology of CSC is not certain and various theories are proposed including impaired function of retinal pigment epithelium (RPE), choroidal ischemia and choroidal hyperpermeability leading to RPE damage. Acute CSC with monofocal or paucifocal changes of RPE usually shows spontaneous resolution and has a favorable visual outcome. Chronic CSC is characterized by multifocal or diffuse decompensation of RPE associated with persistent detachment of neurosensory retina. This might lead to cystoid macular degeneration, foveal atrophy and damage to the foveal photoreceptor layer, consequently resulting in irreversible significant visual loss. Photodynamic therapy (PDT) was proposed for the treatment of chronic CSC. Modified parameters of PDT such as shortening of the time of laser emission and reduction of a total light energy have been suggested to reduce the irreversible damages induced by conventional PDT. Recently, intravitreal injection of antibody to vascular endothelial growth factor(VEGF) was proposed as a new treatment option based on the effect of anti-permeability. Several reports demonstrated acceptable outcomes after intravitreal bevacizumab injection, one of anti-VEGF agent. But the clinical results with ranibizumab are not reported yet. The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab injection versus low-fluence PDT in the treatment of chronic CSC.
- Conditions
- Chronic Central Serous Chorioretinopathy
- Being tested
- Verteporfin, ranibizumab
- Keywords
- Chronic central serous chorioretinopathy, Ranibizumab, Photodynamic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerteporfinDrug
Also called Visudyne
a 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery
ranibizumabDrug
Also called Lucentis
Consecutive intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months
| Study group | Role | What they receive |
|---|---|---|
| Low-fluence PDT with Verteporfin | Active comparator | Half the regular laser fluence PDT(Visudyne®; Novartis); a total light energy of 25J/cm2, a light dose rate of 300mW/cm2. If subretinal fluid was sustained after primary treatment, rescue treatment(ranibizumab injection) was considered Receives: Drug: Verteporfin |
| Ranibizumab | Active comparator | Consecutive Intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months. If subretinal fluid was sustained after primary treatment, rescue treatment(low-fluence photodynamic therapy) was considered Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment
number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study
Measured: 12 months
Secondary outcomes (6)
Change From Baseline in logMAR BCVA
the changes from baseline in logMAR BCVA throughout the follow-up period
Measured: 12 months
Change From Baseline in Central Foveal Thickness on OCT
the change from baseline in central foveal thickness measured by OCT throughout the follow-up period
Measured: 12 months
Number of Participants With Leakage on Fluorescein Angiography
number of participants who showed fluorescein leakage after primary or rescue treatment throughout the follow-up period
Measured: 12 months
Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography
change from baseline in the status of choroidal perfusion and hyperpermeability on indocyanine green angiography throughout the follow-up period
Measured: 12 months
Number of Participants Who Underwent Rescue Treatment
number of participants who underwent rescue treatment: ranibizumab injections for the low-fluence PDT group and low-fluence PDT for the ranibizumab group
Measured: 12 months
Number of Participants With Adverse Event
number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startJul 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jang Won Heo
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Korea Ltd.
- Responsible party
- Sponsor-investigator, Jang Won Heo, Seoul National University Hospital
- Investigators
- Jang Won Heo, Professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325181
- Sponsor's protocol ID
- NOV001
- Status last verified
- Apr 2013
- First submitted
- 25 Mar 2011
- Last updated
- 27 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lange 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 40522203Bae 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 21742303
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Efficacy and Safety of Intravitreal Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT01325181
- Acronym / sponsor ID
- NOV001
- Conditions
- Chronic Central Serous Chorioretinopathy
- Keywords
- Chronic central serous chorioretinopathy, Ranibizumab, Photodynamic therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Jang Won HeoUniversity, hospital or other
- Collaborators
- Novartis Korea Ltd.
- Study start
- Jul 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Posted 27 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab injection versus low-fluence PDT in the treatment of chronic CSC.
Detailed description
Central serous chorioretinopathy (CSC) is characterized by serous detachment of the neurosensory retina. The pathophysiology of CSC is not certain and various theories are proposed including impaired function of retinal pigment epithelium (RPE), choroidal ischemia and choroidal hyperpermeability leading to RPE damage. Acute CSC with monofocal or paucifocal changes of RPE usually shows spontaneous resolution and has a favorable visual outcome. Chronic CSC is characterized by multifocal or diffuse decompensation of RPE associated with persistent detachment of neurosensory retina. This might lead to cystoid macular degeneration, foveal atrophy and damage to the foveal photoreceptor layer, consequently resulting in irreversible significant visual loss. Photodynamic therapy (PDT) was proposed for the treatment of chronic CSC. Modified parameters of PDT such as shortening of the time of laser emission and reduction of a total light energy have been suggested to reduce the irreversible damages induced by conventional PDT. Recently, intravitreal injection of antibody to vascular endothelial growth factor(VEGF) was proposed as a new treatment option based on the effect of anti-permeability. Several reports demonstrated acceptable outcomes after intravitreal bevacizumab injection, one of anti-VEGF agent. But the clinical results with ranibizumab are not reported yet. The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab injection versus low-fluence PDT in the treatment of chronic CSC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-fluence PDT with Verteporfin | Active comparator | Drug: VerteporfinHalf the regular laser fluence PDT(Visudyne®; Novartis); a total light energy of 25J/cm2, a light dose rate of 300mW/cm2. If subretinal fluid was sustained after primary treatment, rescue treatment(ranibizumab injection) was considered |
| Ranibizumab | Active comparator | Drug: ranibizumabConsecutive Intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months. If subretinal fluid was sustained after primary treatment, rescue treatment(low-fluence photodynamic therapy) was considered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- best-corrected visual acuity (BCVA) between 0.0 and 1.0 logarithm of the minimal angle of resolution (logMAR)
- presence of subfoveal fluid persisting for 3 months or more on optical coherence tomography (OCT)
- presence of leakage and multifocal/diffuse RPE decompensation on fluorescein angiography (FA)
- choroidal vascular hyperpermeability and abnormal dilation of choroidal vasculature on indocyanine angiography (ICGA)
Key exclusion criteria (5 listed)
- previous treatment, such as laser photocoagulation, PDT, intravitreal injection of steroid or anti-VEGF agent
- evidence of choroidal neovascularization
- any other ocular diseases that could affect visual acuity
- systemic steroid treatment in the previous 12 months
- media opacity such as cataract that could interfere with adequate acquisition of OCT, FA and ICGA images
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 |
|---|---|---|
| VerteporfinAlso: Visudynea 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery | Drug | Low-fluence PDT with Verteporfin |
| ranibizumabAlso: LucentisConsecutive intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months | Drug | Ranibizumab |
Primary outcome
Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment
Time frame: 12 months
number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study
6 secondary outcomes
Change From Baseline in logMAR BCVA
Time frame: 12 months
Change From Baseline in Central Foveal Thickness on OCT
Time frame: 12 months
Number of Participants With Leakage on Fluorescein Angiography
Time frame: 12 months
Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography
Time frame: 12 months
Number of Participants Who Underwent Rescue Treatment
Time frame: 12 months
Number of Participants With Adverse Event
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40522203Lange 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.
- Derived from this study: 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.
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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.
Jang Won Heo, Professor principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Verteporfin and ranibizumab in people with Chronic Central Serous Chorioretinopathy, run by Jang Won Heo at 1 site 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 4 inclusion and 5 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 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 27 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment (time frame: 12 months). 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 NCT01325181, which also lists 2 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 27 May 2013.