TY - JOUR
T1 - Correlation between improvement in visual acuity and QOL after Ranibizumab treatment for age-related macular degeneration patients
T2 - QUATRO study
AU - Oshima, Yuji
AU - Ishibashi, Yumi
AU - Umeda, Naoyasu
AU - Nagata, Tatsuo
AU - Yoshida, Shigeo
AU - Uchio, Eiichi
AU - Kondo, Hiroyuki
AU - Sonoda, Koh hei
AU - Ishibashi, Tatsuro
N1 - Funding Information:
This work was supported by Novartis Pharma Japan (Tokyo Japan) and the JSPS KAKENHI Grant (#Kiban C 17 K11454 [to Y.O.]). We declare that Novartis Pharma provided charges for data collection and statistical analysis. The sponsor did not have any additional role in the study design, data analysis, decision to publish, or preparation of the manuscript.
Funding Information:
This work was supported by the JSPS KAKENHI Grant (#Kiban C 17 K11454 [to Y.O.]). The statistical analyses were performed by Hiroyuki Shimose (Clinical Research Support Center Kyushu, Fukuoka, Japan) and were funded by Novartis Pharma Japan (Tokyo Japan). Yumiko Yoshida (Kurume University, Fukuoka, Japan) provided and cared for the study patients and collected data as participating investigator. We would like to thank Editage ( www.editage.jp ) for English language editing.
Funding Information:
This work was supported by the JSPS KAKENHI Grant (#Kiban C 17 K11454 [to Y.O.]). The statistical analyses were performed by Hiroyuki Shimose (Clinical Research Support Center Kyushu, Fukuoka, Japan) and were funded by Novartis Pharma Japan (Tokyo Japan). Yumiko Yoshida (Kurume University, Fukuoka, Japan) provided and cared for the study patients and collected data as participating investigator. We would like to thank Editage (www.editage.jp) for English language editing.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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 after three initial monthly doses. The best corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at every visit. 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 change in BCVA and QOL 3 months after ranibizumab treatment. QOL outcomes were also assessed in the better and poor BVCA subgroups. Results: The study enrolled 100 patients. The mean logMAR BCVA after treatment improved significantly from 0.43 to 0.30 at 3 months (p< 0.0001), and 0.28 at 12 months (p< 0.0001). The mean NEI-VFQ-25 composite scores improved from 79.48 to 84.13 at 3 months (p< 0.0001), and 86.0 at 12 months (p< 0.0001). The 3 and 12-month changes in NEI-VFQ-25 score and BCVA showed significant correlation. In the poor baseline visual acuity group (decimal BCVA ≤0.5), there was a significant correlation between the changes in the NEI-VFQ-25 score and BCVA (p=0.02) but not in the better baseline visual acuity group (decimal BCVA > 0.6, p=0.1) at 3 months. There were no significant differences in the satisfaction questionnaire score from baseline to at 3 months (p=0.54) and 12 months (p=0.23). The average CMT improved significantly from 340 to 264 μm at 3 months (p< 0.0001) and to 268 μm at 12 months (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, and this was correlated with changes in VA, except immediately after loading dose treatment in patients with higher baseline VA. The patients’ satisfaction with the treatment remained unchanged during the study period. Trial registration: This study is registered at UMIN Clinical Trials Registry (UMIN000012013). Registered October 10, 2013, as prospective study.
AB - 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 after three initial monthly doses. The best corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at every visit. 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 change in BCVA and QOL 3 months after ranibizumab treatment. QOL outcomes were also assessed in the better and poor BVCA subgroups. Results: The study enrolled 100 patients. The mean logMAR BCVA after treatment improved significantly from 0.43 to 0.30 at 3 months (p< 0.0001), and 0.28 at 12 months (p< 0.0001). The mean NEI-VFQ-25 composite scores improved from 79.48 to 84.13 at 3 months (p< 0.0001), and 86.0 at 12 months (p< 0.0001). The 3 and 12-month changes in NEI-VFQ-25 score and BCVA showed significant correlation. In the poor baseline visual acuity group (decimal BCVA ≤0.5), there was a significant correlation between the changes in the NEI-VFQ-25 score and BCVA (p=0.02) but not in the better baseline visual acuity group (decimal BCVA > 0.6, p=0.1) at 3 months. There were no significant differences in the satisfaction questionnaire score from baseline to at 3 months (p=0.54) and 12 months (p=0.23). The average CMT improved significantly from 340 to 264 μm at 3 months (p< 0.0001) and to 268 μm at 12 months (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, and this was correlated with changes in VA, except immediately after loading dose treatment in patients with higher baseline VA. The patients’ satisfaction with the treatment remained unchanged during the study period. Trial registration: This study is registered at UMIN Clinical Trials Registry (UMIN000012013). Registered October 10, 2013, as prospective study.
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U2 - 10.1186/s12886-021-01816-7
DO - 10.1186/s12886-021-01816-7
M3 - Article
C2 - 33485320
AN - SCOPUS:85099961591
SN - 1471-2415
VL - 21
JO - BMC Ophthalmology
JF - BMC Ophthalmology
IS - 1
M1 - 58
ER -