Polypoidal Choroidal Vasculopathy Without Active Polyp
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment of polypoidal choroidal vasculopathy without active polyp.
Interventions
DRUGaflibercept
1. Three monthly intravitreal aflibercept (2mg) injections 2. Five bimonthly intravitreal aflibercept (2mg) injections 3. Rescue treatment: Verteporfin photodynamic therapy * Loss of five ETDRS letters or one Snellen line of vision from baseline * Presence of subretinal fluid or intraretinal fluid despite three consecutive (monthly or bimonthly) aflibercept injection * Presence of active polyp on indocyanine green angiography
Sponsors
Seoul National University Bundang Hospital
Kim's Eye Hospital
Bayer
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* polypoidal choroidal vasculopathy without active polyp * decreased visual acuity by subretinal fluid and hemorrhage involving foveal center
Exclusion criteria
* polypoidal choroidal vasculopathy with active polyp * previous photodynamic therapy more than three times * anti-VEGF injection within one month * photodynamic therapy or intraocular steroid treatment within three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of best-corrected visual acuity (ETDRS letters) | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| presence of subretinal hemorrhage | during 1 year | Total number of months when subretinal hemorrhage are detected on fundus photographs. |
| presence of fluid in macula evidenced by optical coherence tomography | during 1 year | Total number of months when fluid in macula are detected on optical coherence tomography |
| change of indocyanine green angiography | during 1 year | Change of indocyanine green angiography will include followings 1. New appearance of polypoidal structure 2. Any change in size of the greatest linear dimension of lesion 3. Any change in size and activity of branching vascular network |
| Number of eyes which need rescue treatment (photodynamic therapy) | during 1 year | In this study, photodynamic therapy will be performed as a rescue therapy according to the necessary criteria. |
| safety outcomes | one year | frequency and severity of ocular adverse event |
Countries
South Korea
Outcome results
None listed