Two poster presentations to be shared at AAO 2019 will aim to shed light on polypoidal choroidal vasculopathy (PCV) treatments and adverse events.
The first, “ATLANTIC Study: Aflibercept Monotherapy vs. Aflibercept With PDT in Polypoidal Choroidal Vasculopathy,” compared intravitreal aflibercept treat-and-extend (IVA-TAE) plus sham photodynamic therapy (sPDT) to IVA-TAE with verteporfin PDT (vPDT) in PCV patients. The randomized, double-masked, sham-controlled, Phase 4 investigator-driven clinical trial spanned 52 weeks and 14 centers in Portugal and Spain. PCV patients received IVA 2 mg plus sPDT or IVA 2 mg plus vPDT. The main outcomes were change in best corrected visual acuity (BCVA) compared to baseline and 52-week polyp regression.
Final analysis included 50 patients (mean age, 72.6 ± 9.2 years; all patients were white) with a mean baseline BCVA of 62.8 ± 12.1 ETDRS letters. After 16 weeks, 42% of eyes needed PDT; only one patient required subsequently PDT. BCVA gains and polyps regression did not largely differ at final follow-up. The authors concluded that PDT did not provide any functional or anatomic benefit at one year in this PCV patient population.
The second study, “Incidence Rate of Massive Submacular Hemorrhage and Its Risk Factors in Polypoidal Choroidal Vasculopathy and Typical nAMD,” analyzed the incidence rate of and risk factors associated with massive submacular hemorrhage in patients with PCV and typical neovascular AMD (tnAMD). This retrospective study included 465 total patients (PCV, n = 245; tnAMD, n = 220). Cumulative incidences of and associated risk factors with massive submacular hemorrhage were evaluated.
Overall, 32 PCV patients and nine tnAMD patients developed massive submacular hemorrhage. From the initial visit, one-, five-, and 10-year incidence rates of massive submacular hemorrhage in PCV patients were 2.5%, 11.1%, and 29.9%, respectively, and in tnAMD patients were 1.8%, 4.3%, and 9.9%, respectively—presenting a significantly higher incidence rate in PCV than in tnAMD (P = 0.007). The most significant risk factor in PCV patients was mean number of annual photodynamic therapies (hazard ratio [HR] = 4.24), and for tnAMD patients was mean number of annual anti- vascular endothelial growth factor injections (HR = 1.58).