Timing of Complete Polypoidal Regression after Intravitreous Aflibercept Treatments in Polypoidal Choroidal Vasculopathy

Abstract

Purpose: To understand timing of complete polypoidal regression on indocyanine green angiography (ICGA) after aflibercept injections for polypoidal choroidal vasculopathy (PCV). Design: Multicenter prospective study. Participants: Adults with treatment-naïve PCV. Methods: After institutional review board approval, participants were enrolled and followed up for 1 year, from Apr 1, 2016, through Dec 30, 2018, at 2 university-based centers in Thailand. Diagnosis of PCV was based on the Efficacy and Safety of Verteporfin Photodynamic Therapy in Combination with Ranibizumab or Alone versus Ranibizumab Monotherapy in Patients with Symptomatic Macular Polypoidal Choroidal Vasculopathy criteria. Eligible eyes received fixed-dose aflibercept injections (3 monthly then every 8 weeks), or monthly if fluid persisted on OCT. Photodynamic therapy (PDT) was administered when fluid persisted despite 6 consecutive injections. Indocyanine green angiography was performed at baseline and then every 8 weeks. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was administered at baseline, 6 months, and 1 year. Two retina specialists reviewed posttreatment ICGA, categorized into: complete regression (complete disappearance of polypoidal lesions), partial regression (reduced in size or number), or no regression. Disagreements were resolved through open adjudication. Main Outcome Measures: Timing of complete regression over 1 year. Results: Final analysis included 40 eyes (39 participants; 100% Thai, 59% women; mean age±standard deviation, 64 ± 8.3 years). At baseline, 90% had 5 or more polypoidal lesions. Ninety-five percent received aflibercept monotherapy, and 5% received rescue PDT per protocol. Polypoidal statuses at 1 year were 55% complete, 40% partial, and 5% no regression. Cumulative rates of complete regression at 2, 4, 6, and 12 months were 28%, 33%, 43%, and 55%. Of 22 eyes with complete regression at 1 year, complete regression was identified first at 2, 4, 6, 8, 10, 12 months in 50%, 9%, 18%, 5%, 9%, and 9%, respectively. Cumulative rates of complete regression among these eyes at 2, 6, and 12 months were 50%, 77%, and 100%, respectively. Median duration of complete regression was 3 months (interquartile range, 2–6 months). Median visual acuity improved from 20/125 (Snellen equivalent) to 20/50; median NEI VFQ-25 scores improved from 80 to 93 from baseline to 1 year. Conclusions: Complete polypoidal regression could occur as early as 2 months after aflibercept injections. Most PCV eyes with complete polypoidal regression at 1 year already showed complete regression within the first 6 months. These findings support consideration of aflibercept for PCV to achieve both anatomic and visual outcomes.