Relationships between Patient-Reported Outcome Measures and Clinical Measures in Naïve Neovascular Age-Related Macular Degeneration Patients Treated with Intravitreal Ranibizumab

Abstract

Our objective was to evaluate changes in patient-reported outcome measures using the NEI-VFQ 25 questionnaire during a treat and extend regimen in naive neovascular Age-Related Macular Degeneration patients, and its correlation with anatomical and functional data. We conducted a prospective observational study. Patients underwent a treat and extend regimen with intravitreal ranibizumab for neovascular Age-Related Macular Degeneration. Initial response was evaluated at 4th month, and subsequently in every follow-up visit. If a clinical response was achieved, the injection interval was extended in two-week increments, up to a maximum of 12 weeks. Quality of life was assessed using the NEI-VFQ 25 questionnaire at baseline, 4th months, and 12th months. Patients were categorized as good or poor responders based on Best corrected visual acuity, central foveal thickness, intraretinal fluid, or subretinal fluid. Treatment with ranibizumab led to a significant improvement in quality of life, with a mean increase in NEI-VFQ 25 score of 4.27 points in the 12th month. No significant differences in improvement were observed between good and poor responders. Quality of life scores in neovascular Age-Related Macular Degeneration patients improved with intravitreal treatment regardless of the clinical response. The early response following the loading phase could indicate better quality of life after one year of treatment, with Best corrected visual acuity being the clinical parameter with the greatest influence on quality of life.

Keywords: age-related macular degeneration; anti-VEGF; patient-reported outcome measures; quality of life; treat and extend.

Figure 1

Star graph showing median NEI-VFQ 25 values from baseline to 4th month, comparing early responders to early poor responders. After the loading phase, we found that good responders presented higher average scores in several subfields. In ocular pain, good responders achieved a mean score of 94.75 (87.5–100), whereas poor responders achieved 87.5 (75–100). In near-distance activities, good responders averaged 75.85 (62.50–91.60) and poor responders 67 (54.17–89.55). In mental health good responders present a higher score 77.25 (67.19–81.25), and poor responders 75 (62.50–84.38). However, none of the differences were significant.

Figure 2

Star graph showing mean NEI-VFQ 25 values at 12th month compared to baseline in both good responders and poor responders at 12th month. None of the differences were statistically significative.

Figure 3

Relationship between Best Corrected Visual Acuity (BCVA) at baseline and NEI-VFQ 25 values. The BCVA achieved at baseline, positively correlated with NEI-VFQ 25 scores in the subfields of: Near activities ((A) Spearman’s ρ = 0.352 p = 0.035) Distance Activities ((B) ρ = −0.327 p = 0.048) and negatively correlated with mental health ((C) ρ = −0.331 p = 0.046). Furthermore, BCVA at baseline correlated, as well, with NEI-VFQ 25 scores at 4th months in the sections of General Vision ((D) ρ = 0.439 p = 0.007), Near activities ((E) ρ = 0.442 p = 0.006) Distance Activities ((F) ρ = 0.377 p = 0.021), Driving ((G) ρ = 0.431 p = 0.045) and Total Score ((H) ρ = 0.402; p = 0.014).

Figure 4

Relationship of Best Corrected Visual Acuity (BCVA) and NEI-VFQ 25 subscales at 4th month. In our series, the BCVA at baseline was positively correlated with NEI-VFQ 25 scores in the subfields of: General Vision ((A) Spearman’s ρ = 0.557 p = <0.001), Near Activities ((B) ρ = 0.540 p = 0.001), Distance Activities ((C) ρ = 0.378 p = 0.021) and Total Score ((E) ρ = 0.392 p = 0.016). BCVA at the 4th month was negatively correlated with Mental Health ((D) ρ = −0.367 p = 0.026). BCVA correlated with the Near Activities score at 12th month ((F) ρ = 0.419 p = 0.001).

Figure 5

Correlations of Best Corrected Visual Acuity (BCVA) and NEI-VFQ 25 subscales at 12th month. BCVA at the 12th month was correlated with the NEI-VFQ 25 subfields of: General Vision ((A) Spearman’s ρ = 0.528 p = 0.001), Distance Activities ((B) ρ = 0.467 p = 0.004), Color Vision ((C) ρ = −0.325 p = 0.05), and Total Score ((D) ρ = 0.340 p = 0.039).

Figure 6

Correlations of total number of injections and NEI-VFQ 25 values for dependency at baseline 4th month and 12th month. Dependency scores in the NEI-VFQ 25 test showed a negative correlation to the total number of injections at different moments: at baseline ((A) Spearman’s ρ = −0.373 p = 0.023), at 4th months ((B) ρ = −0.449 p = 0.05) and at 12th months ((C) ρ = −0.333 p = 0.047).