Impact of Duration of Exposure to Intraretinal Fluid on Visual Outcomes in Neovascular Age-Related Macular Degeneration.

Abstract

Objective: To evaluate the impact of total duration of intraretinal fluid (IRF) exposure on visual acuity and vision-related quality of life in patients with neovascular age-related macular degeneration (nAMD).

Design: A post hoc analysis of integrated data from the VIEW 1 and VIEW 2 trials.

Participants: Patients with nAMD.

Methods: Patients receiving intravitreal ranibizumab 0.5 mg every 4 weeks (Rq4) or intravitreal aflibercept injection 2 mg every 4 weeks (IAI 2q4) or every 8 weeks (IAI 2q8) were evaluated. Data were pooled across treatment groups, and the duration of IRF exposure was assessed by quartiles (Q1: ≤2 weeks; Q2: 3-≤8 weeks; Q3: 9≤18 weeks; Q4: >18 weeks). Changes from baseline in visual acuity and vision-related quality of life were evaluated by quartiles of duration of IRF exposure in the pooled treatment group and each treatment group.

Main outcome measures: Mean changes from baseline in best-corrected visual acuity (BCVA) and improvement in vision-related quality of life as assessed via National Eye Institute Visual Function Questionnaire-25 (VFQ-25) composite and subscale scores at Week 52.

Results: A total of 1804 patients were evaluated. In the pooled analysis, mean BCVA gains from baseline at Week 52 for Q1, Q2, Q3, and Q4 were +10.9, +10.1, +9.4, and +6.6 letters, respectively (LS mean difference Q4-Q1 [95%CI]; -4.3 [-6.1, -2.5]). Mean changes from baseline to Week 52 in VFQ-25 composite score for Q1, Q2, Q3, and Q4 were +5.9, +6.6, +6.1, and +4.0 points, respectively (-1.9 [-3.6, -0.2]). A similar trend was observed across VFQ-25 subscales, with patients in Q4 generally experiencing less improvement versus Q1. When BCVA gains were assessed by quartiles of duration of IRF exposure within each treatment group, mean BCVA gains for Q1, Q2, Q3, and Q4 were +11.0, +11.1, +9.3, and +5.8 letters for Rq4 (nominal P<0.05; Q4 vs. Q1); +10.7, +9.7, +9.2, and +7.7 letters for IAI 2q4; and +11.3, +11.2, +8.6, and +6.3 letters for IAI 2q8 (nominal P<0.05; Q4 vs. Q1), respectively.

Conclusions: Increasing duration of IRF exposure was associated with lower visual gains and less improvement in vision-related quality of life in patients with nAMD.