Correlation between improvement in visual acuity and QOL after Ranibizumab treatment for age-related macular degeneration patients: QUATRO study. 2021

Yuji Oshima, and Yumi Ishibashi, and Naoyasu Umeda, and Tatsuo Nagata, and Shigeo Yoshida, and Eiichi Uchio, and Hiroyuki Kondo, and Koh-Hei Sonoda, and Tatsuro Ishibashi
Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. yuji@eye.med.kyushu-u.ac.jp.

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. BACKGROUND This study is registered at UMIN Clinical Trials Registry ( UMIN000012013 ). Registered October 10, 2013, as prospective study.

UI MeSH Term Description Entries
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D011788 Quality of Life A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069579 Ranibizumab A recombinant humanized monoclonal antibody fragment that binds VEGF-A to prevent its binding to VEGFR-1 and VEGFR-2 receptors. This activity reduces vessel permeability and angiogenesis in the treatment of neovascular age-related MACULAR DEGENERATION. Lucentis,RhuFab V2,V2, RhuFab
D014792 Visual Acuity Clarity or sharpness of OCULAR VISION or the ability of the eye to see fine details. Visual acuity depends on the functions of RETINA, neuronal transmission, and the interpretative ability of the brain. Normal visual acuity is expressed as 20/20 indicating that one can see at 20 feet what should normally be seen at that distance. Visual acuity can also be influenced by brightness, color, and contrast. Acuities, Visual,Acuity, Visual,Visual Acuities
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D042461 Vascular Endothelial Growth Factor A The original member of the family of endothelial cell growth factors referred to as VASCULAR ENDOTHELIAL GROWTH FACTORS. Vascular endothelial growth factor-A was originally isolated from tumor cells and referred to as "tumor angiogenesis factor" and "vascular permeability factor". Although expressed at high levels in certain tumor-derived cells it is produced by a wide variety of cell types. In addition to stimulating vascular growth and vascular permeability it may play a role in stimulating VASODILATION via NITRIC OXIDE-dependent pathways. Alternative splicing of the mRNA for vascular endothelial growth factor A results in several isoforms of the protein being produced. Vascular Endothelial Growth Factor,Vascular Endothelial Growth Factor-A,GD-VEGF,Glioma-Derived Vascular Endothelial Cell Growth Factor,VEGF,VEGF-A,Vascular Permeability Factor,Vasculotropin,Glioma Derived Vascular Endothelial Cell Growth Factor,Permeability Factor, Vascular
D057135 Wet Macular Degeneration A form of RETINAL DEGENERATION in which abnormal CHOROIDAL NEOVASCULARIZATION occurs under the RETINA and MACULA LUTEA, causing bleeding and leaking of fluid. This leads to bulging and or lifting of the macula and the distortion or destruction of central vision. Degeneration, Wet Macular,Degenerations, Wet Macular,Macular Degeneration, Wet,Macular Degenerations, Wet,Wet Macular Degenerations
D058449 Intravitreal Injections The administration of substances into the VITREOUS BODY of the eye with a hypodermic syringe. Injection, Intravitreal,Injections, Intravitreal,Intravitreal Injection
D020533 Angiogenesis Inhibitors Agents and endogenous substances that antagonize or inhibit the development of new blood vessels. Angiogenesis Factor Inhibitor,Angiogenesis Inhibitor,Angiogenetic Antagonist,Angiogenetic Inhibitor,Angiogenic Antagonist,Angiogenic Antagonists,Angiogenic Inhibitor,Angiostatic Agent,Angiostatic Agents,Anti-Angiogenetic Agent,Anti-Angiogenic Drug,Anti-Angiogenic Drugs,Antiangiogenic Agent,Neovascularization Inhibitor,Neovascularization Inhibitors,Angiogenesis Factor Inhibitors,Angiogenetic Antagonists,Angiogenetic Inhibitors,Angiogenic Inhibitors,Antagonists, Angiogenic,Anti-Angiogenesis Effect,Anti-Angiogenesis Effects,Anti-Angiogenetic Agents,Antiangiogenesis Effect,Antiangiogenesis Effects,Antiangiogenic Agents,Inhibitors, Angiogenesis,Inhibitors, Angiogenetic,Inhibitors, Angiogenic,Inhibitors, Neovascularization,Agent, Angiostatic,Agent, Anti-Angiogenetic,Agent, Antiangiogenic,Agents, Angiostatic,Agents, Anti-Angiogenetic,Agents, Antiangiogenic,Antagonist, Angiogenetic,Antagonist, Angiogenic,Antagonists, Angiogenetic,Anti Angiogenesis Effect,Anti Angiogenesis Effects,Anti Angiogenetic Agent,Anti Angiogenetic Agents,Anti Angiogenic Drug,Anti Angiogenic Drugs,Drug, Anti-Angiogenic,Drugs, Anti-Angiogenic,Effect, Anti-Angiogenesis,Effect, Antiangiogenesis,Effects, Anti-Angiogenesis,Effects, Antiangiogenesis,Factor Inhibitor, Angiogenesis,Factor Inhibitors, Angiogenesis,Inhibitor, Angiogenesis,Inhibitor, Angiogenesis Factor,Inhibitor, Angiogenetic,Inhibitor, Angiogenic,Inhibitor, Neovascularization,Inhibitors, Angiogenesis Factor

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