scholarly journals Safety and tolerability of ranibizumab in uni/bilateral neovascular age-related macular degeneration: 12-month TWEYEs study

2019 ◽  
Vol 104 (1) ◽  
pp. 64-73
Author(s):  
Francesco Bandello ◽  
Giovanni Staurenghi ◽  
Federico Ricci ◽  
Edoardo Midena ◽  
Francesco Viola ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Open Label ◽  
Age Related ◽  
Risk Period ◽  
The Mean ◽  
Low Incidence ◽  
To Receive ◽  
Systemic Drug

BackgroundTo evaluate the safety and tolerability of ranibizumab 0.5 mg in patients with uni/bilateral neovascular age-related macular degeneration (nAMD) and best-corrected visual acuity (BCVA)<2/10 and/or second eye affected, regardless of BCVA.MethodsIn this 12-month, prospective, multicentre, open-label, single arm, pragmatic interventional study, patients (N=941) aged ≥ 50 years were to receive ranibizumab as per approved label, monthly until maximum stable visual acuity (VA) was achieved (initially, three or more injections may be required). Thereafter, patients were to be monitored monthly for VA and treatment was to be resumed if VA was reduced due to disease activity.ResultsOf the 936 patients treated with ranibizumab at least once during the study, 823/113 were unilaterally/bilaterally (not simultaneously) treated . The mean (SD) number of ranibizumab injections during the study was 5.4 (2.9)/10.6 (5.0) injections in uni/bilaterally treated patients. Three systemic drug-related adverse events (AEs) (all serious, all in unilaterally treated patients) and 18 systemic AE of special interest (AESIs) (11 serious, 16/2 in unilaterally/bilaterally treated patients) occurred during the study. The annual incidence rate (AIR) (events/1000 person-years) for systemic drug-related AEs, considering a 15-day/30-day risk period, 11.0/8.5 for unilaterally treated patients. Considering the same risk period, the AIR (events/1000 person-years) for systemic AESIs for unilaterally treated patients was 22.1/19.9. Considering a 30-day risk period, the AIR (events/1000 treated eye-years) of ocular drug-related AEs was 23 and AESIs was 11.5.ConclusionsThe low incidence of AEs and AESIs demonstrated the good safety and tolerability of ranibizumab in unilaterally/bilaterally treated patients with nAMD in this real-world setting.

scholarly journals Effect of Ranibizumab Treatment in Cases of Choroidal Neovascular Membranes Secondary to Pathological Myopia versus Age-Related Macular Degeneration

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
M S Abdaltawab ◽  
Z F Ismail ◽  
W M A Ebeid ◽  
S M Fawzy
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Intravitreal Injections ◽  
P Value ◽  
Newly Diagnosed ◽  
Pathological Myopia ◽  
Age Related ◽  
Significant Difference ◽  
The Mean

Abstract Aim of the Work The aim of this work is to compare the response of treatment with ranibizumab in terms of visual acuity in cases of CNV secondary to pathological myopia versus CNV secondary to age-related macular degeneration. Methods This prospective, comparative study included ten eyes newly diagnosed as having CNV secondary to pathological myopia, and 10 eyes newly diagnosed as having subfoveal active CNV secondary to AMD. All patients had 3 monthly intravitreal Injections of 0.50 mg (in 0.05 ml of solution) ranibizumab with monthly evaluation of best corrected visual acuity (BCVA) by Landolt C chart, and also calculated in Logarithm of Minimum Angle of Resolution (Log MAR). Results pretreatment there was no significant difference between the two groups as the mean VA (Log Mar) was 1.31 ± 0.2 in AMD group and 1.17 ± 0.3 in MCNV group of P value = 0.431 and also post three IVI of ranibizumab showed no significant difference between the two groups as the mean VA (Log Mar) was 1.22 ± 0.2 for AMD and 1.22 ± 0.5 for MCNV of P value = 0.635. Conclusion there was no significant difference in BCVA between AMD and MCNV groups after three intravitreal injections of ranibizumab.

scholarly journals High-addition segmented refractive bifocal intraocular lens in inactive age-related macular degeneration: A multicenter pilot study

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0256985
Author(s):  
Gerd U. Auffarth ◽  
Josef Reiter ◽  
Martin Leitritz ◽  
Karl-Ulrich Bartz-Schmidt ◽  
Fabian Höhn ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Intraocular Lens ◽  
Intraoperative Complications ◽  
Age Related Macular Degeneration ◽  
Open Label ◽  
Age Related ◽  
Near Visual Acuity ◽  
Reading Distance ◽  
Bifocal Intraocular Lens

This multicenter, open-label study aimed to determine the safety and functional outcome of a high-addition segmented refractive bifocal intraocular lens (IOL) in late inactive age-related macular degeneration (AMD). Twenty eyes of 20 patients were enrolled and followed until 12 months after the intervention. Patients underwent cataract surgery with implantation of a LS-313 MF80 segmented refractive bifocal intraocular lens with a near addition of +8.0 D (Teleon Surgical Vertriebs GmbH, Berlin, Germany). The main outcome measures were distance corrected near visual acuity (DCNVA) and safety as determined by intra- and post-operative complications. Secondary outcomes included distance corrected visual acuity (CDVA), uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), the need for magnification to read newspaper, preferred reading distance, speed and performance (logRAD), as well as patient satisfaction. Mean DCNVA improved from 0.95 (±0.19) to 0.74 (±0.35) logMAR, until 6 months after surgery, P<0.05. CDVA improved from 0.70 (±0.23) to 0.59 (±0.30) logMAR, UDVA from 0.94 (±0.25) to 0.69 (±0.34) logMAR, UNVA from 1.08 (±0.19) to 0.87 (±0.43) logMAR. The mean need for magnification decreased from 2.9- to 2.3-fold, preferred reading distance from 23 to 20 cm. No intraoperative complications occurred during any of the surgeries. One patient lost > 2 lines of CDVA between 6 and 12 months, in another case, the study IOL was exchanged for a monofocal one due to dysphotopsia and decreased CDVA. Implantation of a segmented refractive bifocal IOL with +8.0 D addition improves near and distance vision in patients with late AMD and has a satisfactory safety profile.

scholarly journals Correlation Between Improvement in Visual Acuity and QOL After Ranibizumab Treatment for Age-related Macular Degeneration Patients: QUATRO Study

2020 ◽  
Author(s):  
Yuji Oshima ◽  
Yumi Ishibashi ◽  
Naoyasu Umeda ◽  
Tatsuo Nagata ◽  
Shigeo Yoshida ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Patient Satisfaction ◽  
Visual Function ◽  
Age Related Macular Degeneration ◽  
Open Label ◽  
Satisfaction Questionnaire ◽  
Age Related ◽  
The Mean ◽  
Baseline Visual Acuity ◽  
Ranibizumab Treatment

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.

scholarly journals Limited Treatment Response during Follow-up after Switching to Aflibercept in Neovascular Age-related Macular Degeneration

2021 ◽  
Vol 62 (9) ◽  
pp. 1218-1226
Author(s):  
Gon Soo Choe ◽  
Jong Woo Kim ◽  
Chul Gu Kim ◽  
Jae Hui Kim
Keyword(s):  
Visual Acuity ◽  
Retrospective Study ◽  
Macular Degeneration ◽  
Treatment Response ◽  
Visual Outcome ◽  
Age Related Macular Degeneration ◽  
Neovascular Amd ◽  
Age Related ◽  
The Mean

Purpose: To investigate the limited response to aflibercept after switching to aflibercept in neovascular age-related macular degeneration (AMD). Methods: This retrospective study included 70 eyes with neovascular AMD that were initially treated with ranibizumab and then switched to aflibercept. The incidence and timing of the limited response to aflibercept were identified and visual outcome was compared between eyes with and without limited response. In addition, factors predictive of limited response were analyzed. Results: A limited response to aflibercept was noted in approximately 1/5 of the patients who underwent switching to aflibercept in neovascular AMD. Switching to aflibercept was performed at a mean of 16.2 ± 12.7 months after diagnosis. During the mean 34.7 months of follow-up after switching, limited response was noted in 15 eyes (21.4%) at a mean of 22.0 ± 13.9 months after switching. The degree of reduction in visual acuity was mean logMAR 0.34 ± 0.41 in eyes with limited response and mean 0.06 ± 0.20 in eyes without (p = 0.002). In addition, the duration between the diagnosis and the switching was shorter (p = 0.012), and the number of ranibizumab injections before switching was lower (p = 0.016) in eyes with limited response than in eyes without. Conclusions: Patients who showed limited response to aflibercept after switching to aflibercept showed a worse visual outcome. The probability of having a limited response is higher when the switching is performed earlier.

scholarly journals Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study

2019 ◽  
Vol 4 (1) ◽  
pp. e000109 ◽  
Author(s):  
Michel Weber ◽  
Laurent Velasque ◽  
Florence Coscas ◽  
Céline Faure ◽  
Isabelle Aubry ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Safety Data ◽  
Age Related Macular Degeneration ◽  
Loading Dose ◽  
Clinical Practices ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
The Mean ◽  
Wet Amd

Background/aimsTo monitor treatment-naïve patients with wet age-related macular degeneration (wet AMD) receiving intravitreal aflibercept (IVT-AFL) in France.MethodsRAINBOW (Real life use of intravitreal Aflibercept In FraNce - oBservatiOnal study in Wet age-related macular degeneration) is an ongoing, observational, retrospective and prospective 4-year study to assess visual (primary), anatomical and safety outcomes following IVT-AFL treatment in wet AMD patients. We report the interim 12-month outcomes in patients who have already been enrolled.ResultsSafety data were analysed from 586 patients (safety analysis set); and effectiveness data were analysed from 502 patients with at least one follow-up (full-analysis set) and from 353 patients with visual acuity data at baseline and month 12. The mean (SD) best-corrected visual acuity (BCVA) was 56.7 (18.2) letters and the mean (SD) central retinal thickness (CRT) was 395.6 (140.5)µm at baseline. Most patients (76.9%) received a loading dose (first three injections within 90 days). The mean (SD) number of IVT-AFL injections over 12 months was 6.0 (2.1) and 6.6 (1.8) (patients who received a loading dose). The mean (SD) change in BCVA was 5.5 (15.0) letters and 6.8 (14.5) letters (patients who received a loading dose) at month 12 (p<0.001 vs baseline). The mean (SD) CRT reduction was –108.7 (146.8)µm and –116.4 (150.4)µm (loading dose) at month 12 (p<0.001 vs baseline). Overall, 118 (20.1%) patients experienced at least one treatment-emergent adverse event (TEAE), 1.2% experienced ocular TEAEs and 3.9% experienced serious AEs.ConclusionThis 12-month interim analysis showed that IVT-AFL was associated with sustained improvements in a real-world setting. The RAINBOW results are consistent with the VIEW clinical studies.Trial registration numberNCT02279537 Pre-results.

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

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yuji Oshima ◽  
Yumi Ishibashi ◽  
Naoyasu Umeda ◽  
Tatsuo Nagata ◽  
Shigeo Yoshida ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Visual Function ◽  
Age Related Macular Degeneration ◽  
Open Label ◽  
Intravitreal Ranibizumab ◽  
Satisfaction Questionnaire ◽  
Age Related ◽  
The Mean ◽  
Baseline Visual Acuity ◽  
Ranibizumab Treatment

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 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.

scholarly journals Effect of Intravitreal Ranibizumab in the Treatment of Peripapillary Choroidal Neovascularisation

2011 ◽  
Vol 2011 ◽  
pp. 1-4 ◽  
Author(s):  
Hassan Hamoudi ◽  
Torben Lykke Sørensen
Keyword(s):  
Macular Degeneration ◽  
Choroidal Neovascularisation ◽  
Age Related Macular Degeneration ◽  
Intravitreal Ranibizumab ◽  
Subfoveal Choroidal Neovascularisation ◽  
Age Related ◽  
The Mean ◽  
Receive Treatment ◽  
To Receive

Intravitreal ranibizumab therapy is widely used in treatment of subfoveal choroidal neovascularisation (CNV) in age-related macular degeneration. We wanted to study the effect of intravitreal ranibizumab therapy in peripapillary CNV. A prospective recording of treatment outcomes in twelve eyes (12 patients) with peripapillary CNV with intravitreal injections of ranibizumab was performed. The patients received a series of 3 injections 4–6 weeks apart, and then a new ophthalmic examination was made including OCT and further therapy was given if the peripapillary CNV was still active. Nine patients had idiopathic peripapillary CNV, and in 3 patients it was associated to age-related macular degeneration. Followup had to be at least 6 months. The mean follow-up time was 15.9 (range 9–27) months and the mean number of injections 6.2 (3–10). In 10 patients treatment had resulted in an inactivation of the peripapillary CNV, but 3 of them had reactivation, while 2 patients had no inactivation. Currently, 5 patients are continuous to receive treatment. VA improved in 10 patients. Intravitreal ranibizumab therapy appears to be effective in patients with peripapillary CNV, but in some cases there is repeated reactivation or continuous activity of the peripapillary CNV.

scholarly journals Visual acuity dynamics after phacoemulsification in patients with “wet” form of age-related macular degeneration, treated by intravitreal angiogenesis inhibitor injections

2013 ◽  
Vol 6 (1) ◽  
pp. 44-50 ◽  
Author(s):  
Natalya Viktorovna Chistyakova ◽  
Yuriy Sergeevich Astakhov ◽  
Nikita Yuryevich Dal
Keyword(s):  
Visual Acuity ◽  
Cataract Surgery ◽  
Macular Degeneration ◽  
Angiogenesis Inhibitor ◽  
Age Related Macular Degeneration ◽  
Age Related ◽  
The Mean ◽  
The Difference ◽  
Group 2 ◽  
Wet Amd

Design: prospective non-randomized experimental longitudinal cohort study. The aim of the study: to evaluate the visual acuity after phacoemulsification in patients with the “wet” form of age-related macular degeneration, treated by intravitreal angiogenesis inhibitor injections. Materials: 48 patients (48 eyes) with the “wet” form of AMD, treated by intravitreal angiogenesis inhibitor injections, and incipient cataract. All eyes in the study had a diagnosis of “wet” AMD and underwent cataract surgery. They were followed for a minimum of two years after the cataract surgery. The mean age of patients was 78.16 ± 5 years. There were 36 female (75 %) and 12 male (25 %) patients. Results: All patients were retrospectively divided into two groups. Group No. 1 consisted of 23 patients — operated within a year of the diagnosis of “wet” AMD, and group No. 2 which consisted of 25 patients who had a diagnosis of “wet” AMD for longer than one year prior to the cataract surgery. The mean preoperative visual acuity in the 1st group was 0.16 ± 0.07 (median 0.15), and in patients of group 2 — 0.23 ± 0.06 (median 0,2). Mean visual acuity immediately before surgery in the 1st group was 0.13 ± 0.04 (median 0.09), in the 2nd group — 0.12 ± 0.04 (median 0,08). After surgery, in the 1st group, mean visual acuity was — 0.28 ± 0.08 (median 0.25), in the 2nd group —0.18 ± 0.07 (median 0,15). The difference between the two groups was statistically significant, p < 0.01, t-test. Statistically significant visual acuity increase after surgery was registered in both groups and was preserved after one and two years, when compared to the data before surgery: for the 1st group — 0.13 and 0.1; for the 2nd group — 0,1 and 0.07, respectively (p < 0,01, Wilcoxon criterion). Conclusions: Phacoemulsification is reasonable for eyes with the “wet” form of age-related macular degeneration. Patients with shorter “wet” AMD duration obtain a higher visual acuity increase after cataract surgery. Statistically significant visual acuity increase after surgery is preserved in the majority of patients during next 2 years of follow-up.

Centenarians With Age-Related Macular Degeneration

2017 ◽  
Vol 1 (5) ◽  
pp. 310-313
Author(s):  
Maxwell S. Stem ◽  
Danny A. Mammo ◽  
Yoshihiro Yonekawa ◽  
Bozho Todorich ◽  
Benjamin J. Thomas ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Clinical Findings ◽  
Age Related Macular Degeneration ◽  
Neovascular Amd ◽  
Ellipsoid Zone ◽  
Age Related ◽  
Snellen Visual Acuity ◽  
The Mean

Purpose: To report the clinical findings in patients ≥100 years old who have age-related macular degeneration (AMD). Methods: We identified patients ≥100 years old who had non-neovascular AMD, neovascular AMD or both. Results: Sixty-two patients were included. The mean (SD) age was 102 (1.4) years (range, 100-106 years). Most patients were white (n = 51, 82%), women (n = 51, 82%), and had at least 1 eye affected by neovascular AMD (n = 55, 89%). The mean Snellen visual acuity (VA) among eyes with neovascular AMD was worse than that for eyes with non-neovascular AMD (20/600 [range, 20/40-hand motions] vs 20/250 [range, 20/20-hand motions], respectively, P = .03). Eyes with an intact subfoveal ellipsoid zone (EZ) had much better mean VA than eyes with an absent or disrupted EZ (20/50 vs 20/500, P = .002). Conclusion: Most centenarians with AMD in our cohort had the neovascular form, and these individuals tended to have poorer vision than those with non-neovascular AMD. The presence of an intact subfoveal EZ is associated with better VA in eyes with neovascular or non-neovascular AMD compared to eyes with an absent or disrupted EZ.

scholarly journals One-Year Outcomes of 1 Dose versus 3 Loading Doses Followed by Pro Re Nata Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration: The ARTIS Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-6
Author(s):  
Fenghua Wang ◽  
Yuanzhi Yuan ◽  
Ling Wang ◽  
Xiaofeng Ye ◽  
Jingke Zhao ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Link Type ◽  
Age Related ◽  
The Mean ◽  
Pro Re Nata ◽  
One Year ◽  
Number Of Injections

Purpose. To compare the functional and anatomical outcomes of one dose and three loading doses followed by the pro re nata (PRN) regimen in Chinese neovascular age-related macular degeneration (nvAMD) (including polypoidal choroidal vasculopathy (PCV)) patients. Methods. In this multicenter, prospective, open-label, controlled, 12-month study (ClinicalTrials.gov: NCT02810808), patients were randomized (1 : 1) to 1 dose + PRN (PRN group) or 3 loading doses + PRN (LD group) using intravitreal ranibizumab treatment. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were evaluated. The main outcome was the change in BCVA. The noninferiority limit was 5 letters. Results. Forty-five patients in the PRN group and 49 patients in the LD group finished 12-month follow-up. Each group included 4 PCV patients. The mean change in BCVA from baseline was 7.8 letters in the PRN group, compared with 10.9 letters in the LD group (P=0.344). There were no significant differences between two groups in the mean change of CRT (−159.3 μm vs. −120.5 μm) at month 12. The mean number of injections during the 12-month follow-up was 6.0 in the PRN group and 6.8 in the LD group. The proportion of patients who gained an improvement in visual acuity by 15 or more letters was 28.9% in the PRN group and 44.9% in the LD group (P=0.066). Conclusion. One dose + PRN showed noninferior visual gains than 3 loading doses + PRN regimen using ranibizumab in Chinese nvAMD and PCV patients. Number of injections in the PRN group was similar as that in the LD group but remained a potential risk of vision instability during one-year follow-up using OCT-guided retreatment criteria. This trial is registered with NCT02810808.

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