Prospective Study on the Efficacy and Safety of Intravitreal Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
Overview
- Phase
- Phase 1
- Intervention
- Verteporfin
- Conditions
- Chronic Central Serous Chorioretinopathy
- Sponsor
- Jang Won Heo
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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.
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.
Investigators
Jang Won Heo
Associate professor
Seoul National University Hospital
Eligibility Criteria
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
Arms & Interventions
Low-fluence PDT with Verteporfin
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
Intervention: Verteporfin
Ranibizumab
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
Intervention: ranibizumab
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Number of Participants With Leakage on Fluorescein Angiography(12 months)
- Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography(12 months)
- Number of Participants Who Underwent Rescue Treatment(12 months)
- Number of Participants With Adverse Event(12 months)
- Change From Baseline in logMAR BCVA(12 months)
- Change From Baseline in Central Foveal Thickness on OCT(12 months)