1. Efficacy and Safety of Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy: Two-Year Results of the Aflibercept in Polypoidal Choroidal Vasculopathy Study
- Author
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Chui Ming Gemmy Cheung, Shih-Jen Chen, Tatsuro Ishibashi, Won Ki Lee, Tien Yin Wong, Sergio Leal, Tomohiro Iida, Paul Mitchell, Planet Investigators, Zhongqi Zhang, and Yuichiro Ogura
- Subjects
Male ,medicine.medical_specialty ,Visual acuity ,Time Factors ,Fundus Oculi ,Recombinant Fusion Proteins ,Visual Acuity ,law.invention ,fluids and secretions ,Polyps ,Randomized controlled trial ,Double-Blind Method ,law ,Internal medicine ,Clinical endpoint ,Medicine ,Humans ,In patient ,Prospective Studies ,Fluorescein Angiography ,Prospective cohort study ,Aflibercept ,Aged ,Photosensitizing Agents ,business.industry ,Choroid ,Diabetic retinopathy ,Choroid Diseases ,Middle Aged ,medicine.disease ,female genital diseases and pregnancy complications ,Clinical trial ,Ophthalmology ,Receptors, Vascular Endothelial Growth Factor ,Treatment Outcome ,Photochemotherapy ,embryonic structures ,Intravitreal Injections ,Female ,medicine.symptom ,business ,Tomography, Optical Coherence ,medicine.drug ,Follow-Up Studies - Abstract
Purpose We sought to evaluate longer-term efficacy and safety of intravitreal aflibercept monotherapy (IAI) vs IAI plus rescue photodynamic therapy (rPDT) in patients with polypoidal choroidal vasculopathy (PCV). Design This was a prospective multicenter, double-masked, sham-controlled randomized clinical study across 62 centers. Methods In this phase 3b/4 study, patients with PCV with best-corrected visual acuity of 73–24 Early Treatment Diabetic Retinopathy Study letters (20/40–20/320 Snellen equivalent) received IAI 2 mg every 4 weeks until week 12, when they were randomized 1:1 to receive IAI or IAI plus rPDT if rescue criteria were met. Patients not requiring rescue received IAI every 8 weeks; those requiring rescue received IAI every 4 weeks plus sham/active PDT. At week 52 (the primary endpoint), IAI was noninferior to IAI plus rPDT. After week 52, treatment intervals could be extended beyond 8 weeks at the investigators' discretion. Noninferiority of IAI vs IAI plus rPDT for mean best-corrected visual acuity change from baseline to week 96 was evaluated. Results Over 96 weeks, 54 patients (17.0%) met rescue criteria. At week 96, IAI was noninferior to IAI plus rPDT in terms of Early Treatment Diabetic Retinopathy Study letters gained (+10.7 vs +9.1, P = .48). Proportions of patients with complete polyp regression (33.1% vs 29.1%) or without active polyps (82.1% vs 85.6%) were similar. In year 2, the mean number of injections was 4.6 in both arms. No new safety signals were observed. Conclusion IAI monotherapy was noninferior to IAI with rescue PDT up to 96 weeks, and functional and anatomical improvements achieved at 52 weeks were maintained. Few patients required rescue PDT, which provided no additional visual benefit.
- Published
- 2018