Six-Year Outcomes in Subjects with Polypoidal Choroidal Vasculopathy in the EVERESTII Study.

Abstract

The EVERESTII study previously reported that intravitreally administered ranibizumab (IVR) combined with photodynamic therapy (PDT) achieved superior visual gain and polypoidal lesion closure compared to IVR alone in patients with polypoidal choroidal vasculopathy (PCV). This follow-up study reports the long-term outcomes 6years after initiation of the EVERESTII study. This is a non-interventional cohort study of 90 patients with PCV from 16 international trial sites who originally completed the EVERESTII study. The long-term outcomes were assessed during a recall visit at about 6years from commencement of EVERESTII. The monotherapy and combination groups contained 41 and 49 participants, respectively. The change in best-corrected visual acuity (BCVA) from baseline to year6 was not different between the monotherapy and combination groups; - 7.4 ± 23.0 versus - 6.1 ± 22.4 letters, respectively. The combination group had greater central subfield thickness (CST) reduction compared to the monotherapy group at year6 (- 179.9 vs - 74.2µm, p = 0.011). Fewer eyes had subretinal fluid (SRF)/intraretinal fluid (IRF) in the combination versus monotherapy group at year6 (35.4% vs 57.5%, p = 0.032). Factors associated with BCVA at year6 include BCVA (year2), CST (year2), presence of SRF/IRF at year2, and number of anti-VEGF treatments (years2-6). Factors associated with presence of SRF/IRF at year6 include combination arm (OR 0.45, p = 0.033), BCVA (year2) (OR 1.53, p = 0.046), and presence of SRF/IRF (year2) (OR 2.59, p = 0.042). At 6years following the EVERESTII study, one-third of participants still maintained good vision. As most participants continued to require treatment after exiting the initial trial, ongoing monitoring and re-treatment regardless of polypoidal lesion status are necessary in PCV. ClinicalTrials.gov identifier, NCT01846273.