Chronic Central Serous Chorioretinopathy
Conditions
Keywords
Chronic central serous chorioretinopathy, Ranibizumab, Photodynamic therapy
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.
Interventions
DRUGVerteporfin
a 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery
DRUGranibizumab
Consecutive intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months
Sponsors
Novartis Korea Ltd.
Jang Won Heo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment | 12 months | number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Central Foveal Thickness on OCT | 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 | 12 months | number of participants who showed fluorescein leakage after primary or rescue treatment throughout the follow-up period |
| Change From Baseline in logMAR BCVA | 12 months | the changes from baseline in logMAR BCVA throughout the follow-up period |
| Number of Participants Who Underwent Rescue Treatment | 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 | 12 months | number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events |
| Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography | 12 months | change from baseline in the status of choroidal perfusion and hyperpermeability on indocyanine green angiography throughout the follow-up period |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low-fluence PDT | 18 |
| Ranibizumab | 16 |
| Total | 34 |
Baseline characteristics
| Characteristic | Ranibizumab | Low-fluence PDT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 18 Participants | 34 Participants |
| Age Continuous | 48.9 years STANDARD_DEVIATION 7.5 | 51.4 years STANDARD_DEVIATION 8.2 | 50.8 years STANDARD_DEVIATION 7.7 |
| Region of Enrollment Korea, Republic of | 16 participants | 18 participants | 34 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 13 Participants | 15 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: All study eyes were analyzed using intention to treat principle and the last observation forward method
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low-fluence PDT | Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment | 16 participants |
| Ranibizumab | Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment | 2 participants |
Secondary
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
Secondary
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
Secondary
Change From Baseline in logMAR BCVA
the changes from baseline in logMAR BCVA throughout the follow-up period
Time frame: 12 months
Secondary
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
Secondary
Number of Participants With Adverse Event
number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events
Time frame: 12 months
Secondary
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