Clinical trial NCT01325181: Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Central Serous Chorioretinopathy
Keywords: Chronic central serous chorioretinopathy
Ranibizumab
Photodynamic therapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Novartis Korea Ltd.
First posted: 2011-03-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. best-corrected visual acuity (BCVA) between 0.0 and 1.0 logarithm of the minimal angle of resolution (logMAR)
2. presence of subfoveal fluid persisting for 3 months or more on optical coherence tomography (OCT)
3. presence of leakage and multifocal/diffuse RPE decompensation on fluorescein angiography (FA)
4. choroidal vascular hyperpermeability and abnormal dilation of choroidal vasculature on indocyanine angiography (ICGA)

Exclusion Criteria:

1. previous treatment, such as laser photocoagulation, PDT, intravitreal injection of steroid or anti-VEGF agent
2. evidence of choroidal neovascularization
3. any other ocular diseases that could affect visual acuity
4. systemic steroid treatment in the previous 12 months
5. media opacity such as cataract that could interfere with adequate acquisition of OCT, FA and ICGA images

Primary outcomes:
measure: Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment
timeFrame: 12 months
Secondary outcomes:
measure: Change From Baseline in logMAR BCVA
timeFrame: 12 months
measure: Change From Baseline in Central Foveal Thickness on OCT
timeFrame: 12 months
measure: Number of Participants With Leakage on Fluorescein Angiography
timeFrame: 12 months
measure: Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography
timeFrame: 12 months
measure: Number of Participants Who Underwent Rescue Treatment
timeFrame: 12 months
measure: Number of Participants With Adverse Event
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: • Department of Ophthalmology, Seoul National University College of Medicine
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Hospital
name: Jang Won Heo, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.