A Phase 4 interventional study of Three monthly injections of intravitreal aflibercept in Pachychoroid Neovasculopathy, sponsored by Kim's Eye Hospital. Completed at 1 site in South Korea. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Kim's Eye Hospital · Phase 4, Interventional, and Treatment
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.
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.
Kim's Eye Hospital is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Patients diagnosed with treatment naïve pachychoroid neovasculopathy
Diagnostic criteria of PNV
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving three monthly aflibercept injections
Drug: Three monthly injections of intravitreal aflibercept
Three monthly intravitreal injection of aflibercept (2.0mg / 0.05ml) after diagnosis of pathychoroid neovasculopathy.
Area of choroidal layer
Change in the area of each choroidal layer from baseline to week 12. The area will be assessed based on optical coherence tomography (OCT) image.
Time frame: Baseline and Week 12
Subfoveal choroidal thickness
Changes in subfoveal choroidal thickness from baseline to week 12. The thickness will be assessed based on OCT image
Time frame: Baseline and Week 12
Largest choroidal vessel diameter
Changes in the largest choroidal vessel diameter from baseline to week 12. The diameter will be assessed based on OCT image
Time frame: Baseline and Week 12
Choroidal vascularity index (CVI)
Changes in choroidal vascularity index from baseline to week 12. The CVI will be assessed based on OCT image
Time frame: Baseline and Week 12
Lesion size
Changes in lesion size on OCT-angiography from baseline to week 12. The lesion size will be assessed based on OCT angiography image
Time frame: Baseline and Week 12
Best-corrected visual acuity (BCVA)
Changes in BCVA from baseline to week 12. The BCVA will be assessed using manifest refraction with early treatment of diabetic retinopathy score chart
Time frame: Baseline and Week 12
Fluid after loading injections
Resolution of fluid after loading injections from baseline to week 12. The resolution will be assessed based on OCT image
Time frame: Baseline and Week 12
Choroidal morphology changes
Difference in choroidal morphology changes between patients with and without fluid resolution. The morphology changes will be assessed based on OCT image
Time frame: Baseline and Week 12
Central retinal thickness
Changes in central retinal thickness (CRT) from baseline to week 12. The CRT will be assessed based on OCT image.
Time frame: Baseline and Week 12
Plan to share: No
Ran from Dec 2022 to primary completion in May 2024, 16 months.
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Kim's Eye Hospital