Status:
UNKNOWN
Interval of Disease Inactivity After Complete Polypoidal Regression in PCV Receiving Aflibercept
Lead Sponsor:
Chiang Mai University
Conditions:
Polypoidal Choroidal Vasculopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Polypoidal choroidal vasculopathy (PCV), a subtype of neovascular age-related macular degeneration (NV AMD), is an important cause of central visual loss, especially among Asian and African descendant...
Detailed Description
Primary objective: To determine how long there is CNV inactivity on OCT (absence of intraretinal thickening, intraretinal cystoid abnormalities, subretinal fluid, or enlarging pigment epithelial deta...
Eligibility Criteria
Inclusion
- Age of ≥18 years
- Diagnosis of treatment-naïve PCV in either eye
- PCV is defined according to the following criteria Presence of focal subretinal ICGA hyperfluorescence within the first 6 minutes, plus one of the followings; 1) subretinal orange nodule corresponds to hyperfluorescent nodule on ICGA, 2) massive submacular hemorrhage of 4 disc area or larger, 3) nodular appearance on stereoscopic viewing, 4) pulsatile polypoidal lesion, 5) abnormal vascular channel supplying the polypoidal lesion, 6) hypofluorescent halo around the nodule6
- If any participant presents with bilateral PCV in which both eyes are eligible for the study, the eye with worse vision will be chosen as the study eye
Exclusion
- Presence of co-existing vision threatening conditions in the study eye, e.g., diabetic retinopathy, or retinal vascular occlusion
- Presence of ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or any of the excipients in aflibercept
- Inability to obtain good quality imaging due to ocular media abnormalities
- Contraindicate for FFA or ICGA due to the following conditions:
- Allergic to fluorescein or indocyanine green dye
- Allergic to iodine or seafood
- Impaired kidney or liver functions
- Not able to follow up according to the study protocol
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04707027
Start Date
November 1 2020
End Date
November 1 2023
Last Update
January 15 2021
Active Locations (1)
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1
Voraporn Chaikitmongkol
Chiang Mai, Thailand, 50200