Polypoidal Choroidal Vasculopathy
Conditions
Keywords
Polypoidal choroidal vasculopathy, Intravitreal Bevacizumab
Brief summary
1. Primary objectives a. To evaluate the Effects of intravitreal Bevacizumab on polypoidal choroidal vasculopathy(PCV) 2. Secondary objectives 1. To assess the changes in visual acuity 2. To assess the change in lesion characteristics of PCV * size of PCV * fluorescein leakage * foveal thickness 3. To investigate the safety of intravitreal Bevacizumab in patients with PCV 4. To assess the effect of intravitreal Bevacizumab on the recurrence rate and the the incidence of submacular hemorrhage in patients with PCV
Interventions
Sponsors
Asan Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, CNV secondary to PCV * BCVA of 20/40 to 20/320 (Snellen equivalent) * Evidence of presumed recent disease progression (blood, growth by FA, or recent VA loss)
Exclusion criteria
* Uncontrolled glaucoma or any other ocular condition that would prevent an improvement in visual acuity * Media opacity in the study eye that precludes clinical and photographic evaluation * Intraocular surgery \< 1 month before day 0 * Use of heparin/warfarin within 1 month prior to injection * Known allergy or hypersensitivity to fluorescein, indocyanine green or povidone iodine * Contraindication to pupil dilation in either eye * Any condition which precludes patients' ability to comply with study requirements including completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the percentage of patients who gained an improvement in best corrected visual acuity (BCVA) by 15 letters of more. | — |
| To assess the percentage of patients whose final visual acuity resulted in Snellen equivalent of 20/200 or worse | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the resolution time of macular edema, subretinal fluid, and/or pigment epithelial detachment (PED) using optical coherence tomography (OCT) | — |
| To evaluate change in size and leakage of PCV, using fluorescein angiography (FA) and/or indocyanine angiography (ICGA) | — |
Countries
South Korea
Contacts
Primary ContactSun Young Lee, MD
Backup ContactYoung Hee Yoon, MD
Outcome results
None listed