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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
a 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery
Consecutive intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months
• Department of Ophthalmology, Seoul National University College of Medicine
Seoul, Gyeonggi-do, South Korea
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
Time frame: 12 months
Change From Baseline in logMAR BCVA
the changes from baseline in logMAR BCVA throughout the follow-up period
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 12 months