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| Name | Class |
|---|---|
| Novartis Korea Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verteporfin | Drug | a 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in logMAR BCVA | the changes from baseline in logMAR BCVA throughout the follow-up period | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jang Won Heo, Professor | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| • Department of Ophthalmology, Seoul National University College of Medicine | Seoul | Gyeonggi-do | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40522203 | Derived | 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. | |
| 21742303 | Derived | Bae 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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| ID | Title | Description |
|---|---|---|
| FG000 | Low-fluence PDT | |
| FG001 | Ranibizumab |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low-fluence PDT | |
| BG001 | Ranibizumab | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in logMAR BCVA | the changes from baseline in logMAR BCVA throughout the follow-up period | Not Posted | 12 months | ||||||||||||
| Primary | 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 | All study eyes were analyzed using intention to treat principle and the last observation forward method | Posted | Number |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-fluence PDT |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jang Won Heo | Seoul National University Hospital | 82220720836 | hjw68@snu.ac.kr |
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| ID | Term |
|---|---|
| D000077362 | Verteporfin |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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| ranibizumab | Drug | Consecutive intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months |
|
|
| 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 | 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 | 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 | 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 | 12 months |
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| participants |
| 12 months |
|
|
|
| Secondary | 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 | Not Posted | 12 months |
| Secondary | 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 | Not Posted | 12 months |
| Secondary | 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 | Not Posted | 12 months |
| Secondary | 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 | Not Posted | 12 months |
| Secondary | Number of Participants With Adverse Event | number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events | Not Posted | 12 months |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Ranibizumab | 0 | 0 | 0 | 0 |
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |