METHODS: This is a non-interventional cohort study of 90 patients with PCV from 16 international trial sites who originally completed the EVEREST II study. The long-term outcomes were assessed during a recall visit at about 6 years from commencement of EVEREST II.

RESULTS: The monotherapy and combination groups contained 41 and 49 participants, respectively. The change in best-corrected visual acuity (BCVA) from baseline to year 6 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 year 6 (- 179.9 vs - 74.2 µm, p = 0.011). Fewer eyes had subretinal fluid (SRF)/intraretinal fluid (IRF) in the combination versus monotherapy group at year 6 (35.4% vs 57.5%, p = 0.032). Factors associated with BCVA at year 6 include BCVA (year 2), CST (year 2), presence of SRF/IRF at year 2, and number of anti-VEGF treatments (years 2-6). Factors associated with presence of SRF/IRF at year 6 include combination arm (OR 0.45, p = 0.033), BCVA (year 2) (OR 1.53, p = 0.046), and presence of SRF/IRF (year 2) (OR 2.59, p = 0.042).

CONCLUSION: At 6 years following the EVEREST II 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.

STUDY DESIGN: A multicenter, cross-sectional study of the long-term outcomes of a cohort of patients originally treated with ranibizumab alone (monotherapy group) or in combination with photodynamic therapy PDT (combination group) in the EVEREST II study (ClinicalTrials.gov identifier, NCT01846273).

METHODS: Ninety participants from the six-year EVEREST II follow-up: 20 Japanese and 70 non-Japanese were included. Long-term changes in best-corrected visual acuity (BCVA) and central subfield thickness (CST) were reported in the Japanese compared to non-Japanese participants. Number of injections, types of anti-vascular endothelial growth factor (VEGF) agents used, and cases with equal visits and injections, indicating fixed dosing or treat-and-extend (TAE) administration were investigated. Outcomes were also compared between those who had verteporfin PDT during the six-year period (n=14) and those who did not (n=6).

RESULTS: The Japanese and non-Japanese participants had similar baseline characteristics. The mean age for Japanese participants was 76±4.47 years, with 25% being women. BCVA improved from baseline to year 2 in both groups (P < 0.05). At six years, BCVA was maintained in the Japanese (67.2 ETDRS letters) but decreased in the non-Japanese participants (from 68.8 to 53.5 letters). The Japanese participants received more injections than the non-Japanese (12.5 vs. 7.57, P=0.017). Aflibercept was the most frequently used anti-VEGF agent, and the number of fixed dosing or TAE administration was higher in the Japanese participants. No significant differences were found in functional and anatomical outcomes between those who received PDT and those who did not (all P > 0.05). However, non-PDT participants had numerically worse BCVA at the final visit.