Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Study on the Efficacy and Safety of Intravitreal Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy

Conditions
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Chronic Central Serous Chorioretinopathy

Intervention / Treatment
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* Drug: Verteporfin
* Drug: ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low-fluence PDT with Verteporfin<br>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 | Drug: Verteporfin<br>* a 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery<br>* Other names: Visudyne;|
| Active Comparator: Ranibizumab<br>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 | Drug: ranibizumab<br>* Consecutive intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic central serous chorioretinopathy, Ranibizumab, Photodynamic therapy