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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Jang Won Heo

Current 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


Original Primary Outcome: change from baseline in BCVA(the number of ETDRS letters) [ Time Frame: 12 months ]

change from baseline in BCVA(the number of ETDRS letters)


Current Secondary Outcome:

  • Change From Baseline in logMAR BCVA [ Time Frame: 12 months ]
    the changes from baseline in logMAR BCVA throughout the follow-up period
  • Change From Baseline in Central Foveal Thickness on OCT [ Time Frame: 12 months ]
    the change from baseline in central foveal thickness measured by OCT throughout the follow-up period
  • Number of Participants With Leakage on Fluorescein Angiography [ Time Frame: 12 months ]
    number of participants who showed fluorescein leakage after primary or rescue treatment throughout the follow-up period
  • Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography [ Time Frame: 12 months ]
    change from baseline in the status of choroidal perfusion and hyperpermeability on indocyanine green angiography throughout the follow-up period
  • Number of Participants Who Underwent Rescue Treatment [ Time Frame: 12 months ]
    number of participants who underwent rescue treatment: ranibizumab injections for the low-fluence PDT group and low-fluence PDT for the ranibizumab group
  • Number of Participants With Adverse Event [ Time Frame: 12 months ]
    number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events


Original Secondary Outcome:

  • number of participants with complete resolution of subretinal fluid on OCT [ Time Frame: 12 months ]
    number of participants who achieved complete resolution of subretinal fluid on OCT
  • Change From Baseline in Central Foveal Thickness on OCT [ Time Frame: 12 months ]
    change from baseline in central foveal thickness on OCT
  • number of participants with leakage on FA [ Time Frame: 12 months ]
    number of participants who showed sustained leakage on FA
  • change from baseline in choroidal perfusion status on ICGA [ Time Frame: 12 months ]
    change from baseline in the status of choroidal perfusion and hyperpermeability on ICGA
  • number of participants with rescue treatment [ Time Frame: 12 months ]
    number of participants who underwent rescue treatment
  • Number of Participants With Adverse Event [ Time Frame: 12 months ]
    number of participants with adverse event


Information By: Seoul National University Hospital

Dates:
Date Received: March 25, 2011
Date Started: July 2009
Date Completion:
Last Updated: April 5, 2013
Last Verified: April 2013