Correlation Between Improvement in Visual Acuity and QOL After Ranibizumab Treatment for Age-related Macular Degeneration Patients: QUATRO Study
Abstract Background: To evaluate the correlation between visual acuity improvement and vision-related QOL after ranibizumab treatment in Japanese patients with AMD.Methods: In this one-year prospective, interventional, open-label, multicenter study involving four sites, patients with neovascular AMD were enrolled and observed for 12 months. Treatment-naïve patients received 0.5 mg ranibizumab as needed (PRN) after three initial monthly doses. The best corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at every visit. Fluorescein and indocyanine green angiography, and evaluations with the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and patient satisfaction questionnaire were performed at baseline and 3 and 12 months after initial treatment. The primary endpoint was the change in BCVA and QOL 3 months after ranibizumab treatment. Secondary endpoints included change in BCVA, QOL, CMT, and patient satisfaction over 12 months.Results: The study enrolled 100 patients. The mean logMAR BCVA after the 3-month treatment improved significantly from 0.43 to 0.30 (p<0.0001). The mean NEI-VFQ-25 composite scores were higher after 3 months of ranibizumab treatment, improving from 79.48 to 84.13 (p<0.0001). The changes in the NEI-VFQ-25 score and BCVA showed significant correlation in the poor baseline visual acuity group (decimal BCVA below 0.5, p=0.02) but not in the better baseline visual acuity group (decimal BCVA above 0.6, p=0.1) after the three loading doses. There were no significant differences in the satisfaction questionnaire score from baseline to after the three loading doses (p=0.5466). The average CMT improved significantly from 340 to 264 mm after the loading doses (p<0.0001).Conclusions: Intravitreal ranibizumab treatment resulted in improvement in visual acuity, anatomical change, and visual function change in Japanese AMD patients. Significant improvement was seen in patient visual function, but this was not correlated with changes in VA in patients with higher or lower baseline VA. The patients' satisfaction with the treatment remained unchanged during the study period.