Dataset Information

Real-world data on ranibizumab for myopic choroidal neovascularization due to pathologic myopia: results from a post-marketing surveillance in Japan.

ABSTRACT: OBJECTIVES:The aim of this study was to obtain real-world clinical data on the safety and efficacy of ranibizumab treatment for myopic choroidal neovascularization (CNV) due to pathologic myopia. METHODS:This was a prospective, observational, post-marketing surveillance study in ranibizumab-naive Japanese patients with myopic CNV. Patients who initiated ranibizumab treatment were registered and prospectively observed over 12 months. Safety endpoints were the incidence of ocular and non-ocular adverse drug reactions (ADRs) and serious adverse events (SAEs). The efficacy endpoint included the average change in best-corrected visual acuity (BCVA) in logarithm of the minimal angle of resolution (logMAR) units (logMAR BCVA) from baseline to the last observation. RESULTS:Three hundred and eighteen patients were included in the safety analysis population. Of these 79.9% were female and the mean age was 65.5 years. The incidences of SAEs and ADRs were 0.6 and 0.3%, respectively. A total of 268 patients (84.0%) completed the 12-month study period. The mean (±SD) and median number of ranibizumab injections were 2.0?±?1.5 and 1.0 during the 12-month study period, respectively. The number of ranibizumab injections received was one in 52.2% of patients and less than or equal to three in 89.2%. The mean change in logMAR BCVA from baseline to month 12 was -0.193, and the mean logMAR BCVA improved from 0.517 to 0.319 between baseline and month 12. CONCLUSIONS:This study showed that ranibizumab is generally well tolerated, and that a minimum number of injections were necessary to produce a therapeutic effect in Japanese myopic CNV patients in a real-world setting.

SUBMITTER: Ohno-Matsui K

PROVIDER: S-EPMC6292850 | biostudies-other | 2018 Aug

REPOSITORIES: biostudies-other

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Real-world data on ranibizumab for myopic choroidal neovascularization due to pathologic myopia: results from a post-marketing surveillance in Japan.

Ohno-Matsui Kyoko K Suzaki Makoto M Teshima Rie R Okami Nina N

Eye (London, England) 20180829 12

<h4>Objectives</h4>The aim of this study was to obtain real-world clinical data on the safety and efficacy of ranibizumab treatment for myopic choroidal neovascularization (CNV) due to pathologic myopia.<h4>Methods</h4>This was a prospective, observational, post-marketing surveillance study in ranibizumab-naive Japanese patients with myopic CNV. Patients who initiated ranibizumab treatment were registered and prospectively observed over 12 months. Safety endpoints were the incidence of ocular an ...[more]

PMID: 30158574

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Project description:PURPOSE:To assess the 1-year effectiveness, safety, and treatment patterns of ranibizumab in patients with myopic choroidal neovascularization (mCNV) enrolled in the LUMINOUS study. METHODS:This 5-year, prospective, multicenter, observational, study enrolled 30,138 patients across all approved ranibizumab indications from outpatient ophthalmology clinics. 297 consenting patients (≥18 years) with mCNV who were treatment-naïve or prior-treated with ranibizumab or other ocular treatments were enrolled, and treated with ranibizumab according to the local product label. The main outcomes are visual acuity (VA; Early Treatment Diabetic Retinopathy Study letters or equivalent), adverse events during the study, and treatment exposure over 1 year. Results are presented by prior treatment status of the study eye and injection frequency. RESULTS:Of the 297 mCNV patients recruited in the study, 108 were treatment-naïve and 175 were prior ranibizumab-treated. At baseline, the mean age of patients was 57.6 years, and 59.0 years and 80.6% and 65.7% were female in the treatment-naïve and prior ranibizumab-treated groups, respectively. Most were Caucasian (treatment-naïve, 88.9%; prior ranibizumab-treated, 86.9%). The mean (±standard deviation [SD]) VA letter changes to 1 year were +9.7 (±17.99) from 49.5 (±20.51) and +1.5 (±13.15) from 58.5 (±19.79) and these were achieved with a mean (SD) of 3.0 (±1.58) and 2.6 (±2.33) injections in the treatment-naïve and prior ranibizumab-treated groups, respectively. Presented by injection frequencies 1-2, 3-4 and ≥5 injections in Year 1, the mean (SD) VA changes were +15.0 (±14.70), +7.7 (±19.91) and -0.7 (±16.05) in treatment-naïve patients and +1.5 (±14.57), +3.1 (±11.53) and -3.6 (±11.97) in prior ranibizumab-treated patients, respectively. The safety profile was comparable with previous ranibizumab studies. CONCLUSIONS:Ranibizumab treatment for mCNV showed robust VA gains in treatment-naïve patients and VA maintenance in prior ranibizumab-treated patients in a clinical practice setting, consisting mainly of Caucasians. No new safety signals were observed during the study.

Project description:The Ranibizumab for the Treatment of Choroidal Neovascularisation (CNV) Secondary to Pathological Myopia (PM): an Individualized Regimen (REPAIR) trial was a prospective study exploring the efficacy and safety of intravitreal ranibizumab 0.5 mg using an individualized treatment regimen over 12 months. The current study investigated the impact of treatment with ranibizumab as needed (pro re nata [PRN]) on individuals with myopic choroidal neovascularization (mCNV) in the REPAIR study, using patient-reported outcome measures (PROMs) for treatment satisfaction and well-being. This study included 65 adults with mCNV and a best-corrected visual acuity (BCVA) letter score of 24-78 in the study eye. Patients completed the Macular Disease Treatment Satisfaction Questionnaire (MacTSQ) at months 1, 6 and 12, and the 12-item Well-Being Questionnaire (W-BQ12) at baseline and months 1, 6 and 12. Subgroup analyses investigated the relationship between PROM scores and treatment in the better- or worse-seeing eye (BSE/WSE), number of injections received, baseline BCVA, BCVA improvement and age. Pearson correlations between change in BCVA, MacTSQ scores and W-BQ12 scores were calculated. The main outcome measures were treatment satisfaction measured with the MacTSQ (score 0-72) and well-being measured with the W-BQ12 (score 0-36). Treatment satisfaction significantly increased over the study period (p = 0.0001). Mean MacTSQ scores increased by 9.7 and 10.0 in patients treated in their WSE and BSE, respectively. Treatment satisfaction was highest in individuals receiving only one injection at month 1; however, by month 12, scores were similar across injection subgroups. Patients aged 68 years or older had the highest MacTSQ scores. Well-being scores also significantly increased over the study period (p = 0.03). Mean W-BQ12 scores increased by 1.7 in patients treated in their WSE and by 2.1 in patients treated in their BSE. Individuals aged 40 years or younger had the greatest increases in general well-being. Patients who experienced stable or improved BCVA at month 12 had greater increases in W-BQ12 scores than those who experienced a decrease. Correlations between BCVA, MacTSQ scores and W-BQ12 scores were largely non-significant. In conclusion, treatment satisfaction and well-being increased during treatment with ranibizumab PRN. Although directly comparable data are limited for the MacTSQ and W-BQ12 in mCNV, these results complement PROM outcomes reported in related studies.

Dataset Information

Real-world data on ranibizumab for myopic choroidal neovascularization due to pathologic myopia: results from a post-marketing surveillance in Japan.

Publications

Real-world data on ranibizumab for myopic choroidal neovascularization due to pathologic myopia: results from a post-marketing surveillance in Japan.

Similar Datasets

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