NCT05662410

Choroidal Morphology Changes After Aflibercept Therapy in Pachychoroid Neovasculopathy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Kim's Eye Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

In the present study, investigators attempt to evaluate the short-term, detailed changes in choroidal morphology after three monthly injections of aflibercept in pachychoroid neovasculopathy. The association between these changes and clinical outcomes will be additionally investigated. The primary purpose of this study is to provide reference data regarding the aflibercept-related morphologic changes that implicate structural and functional choroidal alteration, and hence its clinical implications.

Detailed description

Pachychoroid neovasculopathy (PNV), is a recently proposed entity after advancements in retinal imaging, belonging to the pachychoroid spectrum of diseases. It is a prevalent subtype of neovascular age-related macular degeneration (AMD) in the Asian population (19.5%\~41.6% among neovascular AMD), characterized by presence of type 1 macular neovascularization (MNV) without polypoidal lesion in an eye exhibiting pachychoroid features, although its pathogenesis is not fully understood. In addition, PNV can be distinguished from typical neovascular AMD by a relative absence of drusen or pseudodrusen, younger age of onset, and thickened choroid with pachyvessels. Although both neovascular AMD and PNV respond well to anti-vascular endothelial growth factor (VEGF) therapy, separate analysis of treatment outcomes in PNV merits further investigation targeting the different underlying pathologies. It is well-known that anti-VEGF therapy influences choroidal structures, including choroidal thickness, choroidal vascularity index, and choroidal area. In general, decrease in choroidal thickness after aflibercept injection is more prominent than that after ranibizumab or bevacizumab injections. Some investigators postulated that this difference in the effect on choroid is responsible for the superior efficacy of aflibercept in polypoidal choroidal vasculopathy (PCV) over other anti-VEGF agents and influence the choice of anti-VEGF agent in real-world practice. To date, several investigators have demonstrated changes in choroidal thickness after anti-VEGF therapy in PNV. However, the detailed changes in choroidal morphology after aflibercept therapy and its clinical implications in pachychoroidal neovasculopathy remain to be elucidated. In the present study, investigators attempt to evaluate the short-term, detailed changes in choroidal morphology after three monthly injections of aflibercept in pachychoroid neovasculopathy. The association between these changes and clinical outcomes will be additionally investigated. The primary purpose of this study is to provide reference data regarding the aflibercept-related morphologic changes that implicate structural and functional choroidal alteration, and hence its clinical implications.

Conditions

• Pachychoroid Neovasculopathy

Interventions

Type	Name	Description
DRUG	Three monthly injections of intravitreal aflibercept	Three monthly intravitreal injection of aflibercept (2.0mg / 0.05ml) after diagnosis of pathychoroid neovasculopathy.

Timeline

• Start date: 2022-12-26
• Primary completion: 2024-05-24
• Completion: 2024-05-26
• First posted: 2022-12-22
• Last updated: 2025-05-31

Locations

1 site across 1 country: South Korea