Interval of Disease Inactivity After Complete Polypoidal Regression in PCV Receiving Aflibercept
Status:
Recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
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 descendants. PCV is characterized by the presence of hyperfluorescent polypoidal
lesions, with or without branching vascular network, identified on indocyanine green
angiography (ICGA), currently the gold standard for PCV diagnosis.
In addition to visual improvement from baseline, polypoidal regression or complete
disappearance of polypoidal lesions on ICGA has been considered an important treatment
outcome in large PCV trials including the PLANET1 and EVEREST II2 studies. Rate of polypoidal
regression following intravitreous aflibercept monotherapy was 33% in the PLANET study1 year
2 and ranged between 55% to 78% in other Asian cohorts.3-4
Recently, our previous investigation5 on the timing of polypoidal regression following a
fixed-dosing aflibercept monotherapy (3 initial monthly injections, then q 8 weeks until 1
year) in 40 Thai PCV eyes suggested that, among 22 eyes (55%) with polypoidal regression at 1
year, a majority of them showed complete polypoidal regression before 6 months (median
duration of complete regression: 3 months (IQR, 2 months to 6 months).
However, due to the fixed-dosing regimen used in previous study, there are limited data on
how often polypoidal lesions remain regressed on ICGA when the treatment is deferred in eyes
with polypoidal regression, nor what changes might be seen subsequently on OCT when treatment
is deferred in this situation. Therefore, this study aims to determine the changes seen on
OCT subsequent to complete regression of polypoidal lesions on ICGA in PCV eyes following
intravitreous aflibercept treatment.
Results from this study may provide some insights on longer-term PCV management