To evaluate the 2-year efficacy, durability, and safety of faricimab in patients with diabetic macular edema (DME) in the YOSEMITE Japan subgroup. YOSEMITE/RHINE (NCT03622580/NCT03622593) subgroup analysis: global, multicenter, randomized, double-masked, active-comparator–controlled, phase 3 faricimab trials. Patients were randomized 1:1:1 to intravitreal faricimab 6.0 mg every 8 weeks (Q8W) and per treat-and-extend (T E) dosing, or aflibercept 2.0 mg Q8W. Outcomes were assessed through year 2 for the YOSEMITE Japan subgroup (N = 60) and the pooled YOSEMITE/RHINE global cohort (N = 1891). In the YOSEMITE Japan subgroup, 21, 19, and 20 patients were randomized to faricimab Q8W, faricimab T E, and aflibercept Q8W, respectively (632, 632, and 627 patients in the pooled YOSEMITE/RHINE cohort). Vision gains and anatomic improvements with faricimab at year 1 were maintained over 2 years and were generally consistent between groups. Mean best-corrected visual acuity changes from baseline at year 2 (weeks 92–100 average) for the YOSEMITE Japan subgroup were +12.5, +9.0, and +5.0 letters in the faricimab Q8W, faricimab T E and aflibercept Q8W arms, respectively (+10.8, +10.4, and +10.3 letters in the pooled YOSEMITE/RHINE cohort). At week 96, 61.1
To evaluate efficacy, durability, and safety of faricimab in Japanese patients with diabetic macular edema (DME). Subgroup analysis of 2 global, multicenter, randomized, double-masked, active-comparator–controlled, phase 3 trials (YOSEMITE, NCT03622580; RHINE, NCT03622593). Patients with DME were randomized 1:1:1 to intravitreal faricimab 6.0 mg every 8 weeks (Q8W), faricimab 6.0 mg per personalized treatment interval (PTI), or aflibercept 2.0 mg Q8W through week 100. Primary endpoint was best-corrected visual acuity (BCVA) change from baseline at 1 year, averaged over weeks 48, 52, and 56. This is the first time 1-year outcomes between Japanese patients (only enrolled into YOSEMITE) and the pooled YOSEMITE/RHINE cohort (N = 1891) have been compared. The YOSEMITE Japan subgroup included 60 patients randomized to faricimab Q8W (n = 21), faricimab PTI (n = 19), or aflibercept Q8W (n = 20). Consistent with global results, the adjusted mean (95.04
Submacular hemorrhage (SMH) can lead to devastating visual loss in patients with age-related macular degeneration. We retrospectively evaluated the surgical outcomes of vitrectomy with subretinal injection of tissue plasminogen activator, bevacizumab, and air in 13 cases. Visual prognosis, anatomical results obtained with optical coherence tomography (OCT), and their correlations were investigated. We analyzed OCT parameters including SMH height, pigment epithelial detachment (PED) height and width, and status of ellipsoid zone (EZ) line. Complete displacement of SMH was achieved in 12 eyes. At 3 months post-surgery, best-corrected visual acuity (BCVA) and SMH height exhibited significant improvements (P < 0.01). In eyes with preoperative SMH height < 300 µm and a detectable EZ line, BCVA was significantly improved at as early as 1 month, whereas the remaining eyes exhibited visual improvements only at 3 months. Postoperative BCVA positively correlated with preoperative BCVA (r = 0.86, P < 0.005), and negatively correlated with SMH size (r = 0.69, P < 0.01) and PED height (r = 0.58, P < 0.05) and width (r = 0.67, P < 0.05). Multivariate analyses confirmed preoperative BCVA as the predominant factor associated with postoperative BCVA (β = 1.093, P < 0.05). In conclusion, significant improvements in BCVA and anatomical findings can be achieved with our reported surgical technique. Preoperative OCT findings may influence the duration required for visual improvements.
Retinal vein occlusion is a disease that causes vision disorder due to occlusion of the retinal vein which is one kind of micro-vascular spreading to the fundus. Most of the current treatments are aimed at suppressing symptoms caused by vascular occlusion. However, there is no method targeting the blood clots which is the root of the disease. In this study, we focused on the impact pressure of micro-jet which is generated by the collapse of the electrical-induced bubbles. This pressure can be worked as local and minimally invasive physical stimuli from the outside of the blood vessel to resolve the vascular occlusion itself. For the current the optimizing design is proposed by evaluating the electric and fluidic field using model experiment and calculations. In this paper, we proposed the electrofluidc optimization design considering the electric double layer capacitor(EDLC).
Retinal vein occlusion is a disease that causes vision disorder due to occlusion of the retinal vein which is one kind of micro-vascular spreading to the fundus. Most of the current treatments are aimed at suppressing symptoms caused by vascular occlusion. In this study, we focused on the impact pressure of micro-jet generated by the collapse of the electrical-induced bubbles. This pressure can be worked as local and minimally invasive physical stimuli from the outside of the blood vessel to resolve the vascular occlusion itself. Capacitance measurements were conducted to sense the approach of the device to the target. In addition, we conducted experiments to eliminate thrombus in vascular occlusion model in vitro and in vivo to establish a new treatment method for retinal vein occlusion targeting vascular occlusion.
For this study, a novel treatment of retinal vein occlusion by physical stimuli of electrically-induced bubbles was proposed. Our device can apply local and minimally-invasive physical stimuli to retinal minute blood vessels with a diameter of about 100 μm, utilizing the impact pressure when microbubbles collapse. Furthermore, it is possible to sense the approach of the device to the target by measuring the capacitance. Vascular vessels of chick embryos whose size is similar to that of the retinal vein, and retinal veins of pig were used as in-vitro and in-vivo model respectively. Also, micro-vascular occlusion models were successfully operated and local physical stimuli was applied to the blood clot which is artificially produced. The 60% of reperfusion against the initial amount was confirmed by blood flow measurement for both in vitro and in vivo environment.
A novel treatment of the retina vein occlusion by using electrically-induced bubble injector is proposed in our laboratory, and which provides physical stimuli to thrombus for reperfusion. For the present study, the micro-vascular of the chicken embryo was employed as a retina vein occlusion phantom as a simple model of alive blood vessel. Artificial blood clot was produced by laser irradiation and the property of it was evaluated. This study will contribute to produce a library of the wide range of properties of blood clot to evaluate the developed devices.
Background/aim We previously reported that ranibizumab performed better on visual prognosis than photodynamic therapy (PDT) in a Ranibizumab (Lucentis) And Photodynamic Therapy On Polypoidal choroidal vasculopathy (LAPTOP) study. To determine if the firstchoice treatment, either PDT or intravitreal ranibizumab, has a long-term effect in patients with polypoidal choroidal vasculopathy (PCV). Methods We reviewed medical records of patientsrandomised to either PDT (29 eyes) or ranibizumab (27 eyes) from July 2009 to June 2011 in LAPTOP study. Retreatment or switching to other treatments were at the investigator's discretion after release from the 2-year LAPTOP study up to 5years. We evaluated visual acuity (VA), continuity of initial treatment, percentage of dry macula achievement and macular atrophy at 5 years. Results The logarithm of minimal angle of resolution VA was 0.56 in the PDT and 0.44 in the ranibizumab groups at baseline (p=0.101) and was 0.55 and 0.28 at 5years, respectively (p<0.05). More than 70% of the patients converted to aflibercept in following years. Achievement percentages of dry macula were 74% (PDT) and 63% (ranibizumab) at 5years, and macular atrophy was detected in 78% (PDT) and 60% (ranibizumab) with a mean area of 7.7 and 3.5 mm2, respectively (p=0.155). Conclusions The better VA in the initial ranibizumab group compared with the PDT group at 2 years was retained at the 5-year follow-up.
Retinal vein occlusion is a disease that causes vision disorder due to occlusion of the retinal vein which is one kind of micro-vascular spreading to the fundus. Most of the current treatments are aimed at suppressing symptoms caused by vascular occlusion. In this study, we focused on the impact pressure of micro-jet generated by the collapse of the electrical-induced bubbles. This pressure can be worked as local and minimally invasive physical stimuli from the outside of the blood vessel to resolve the vascular occlusion itself. The electrical evaluation for electrical-induced bubbles was carried out to establish a new treatment method for retinal vein occlusion targeting vascular occlusion.
A novel treatment of the retina vein occlusion by using electrically-induced bubble injector is proposed. This treatment provides physical stimuli to blood clot for reperfusion by microbubbles. These microbubbles occurred at the tip of electrically-induced bubble injector which has directivity. For the present study, the artificial blood clot was successfully made as a model for evaluations of the physical stimulation of bubbles by hanging drop method. The blood clot in the retina vein is constructed by a red blood cell and fibrin mainly. So we could make different hardness blood clot by controlling quantity of the fibrin. In the experiment, physical stimulation was provided to these artificial clots by bubble injector. It was observed that larger physical stimulation is required to remove a firm artificial blood clot.
Purpose. To evaluate the influences of 27-gauge vitrectomy on corneal topographic conditions. Method. Fifty-six eyes of 56 patients undergoing 27-gauge vitrectomy were retrospectively studied. Twenty-three eyes with epiretinal membrane (ERM), 23 eyes with macular hole (MH), and 10 eyes with proliferative diabetic retinopathy (PDR) were included. Forty-five of the 56 eyes underwent 27-gauge phacovitrectomy (group 1), and the remaining 11 eyes underwent 27-gauge vitrectomy alone (group 2). Corneal topography was obtained with a wave-front analyzer preoperatively and at 1 and 3 months postoperatively. The corneal topographic parameters evaluated were the average corneal power, regular astigmatism, spherical aberration, and higher-order aberration (HOA). Results. In between-group analyses of groups 1 and 2, no significant differences were observed regarding the changes of the 4 parameters from the baseline to 1 and 3 months postoperatively. No significant differences in the changes of all parameters from the baseline to 1 and 3 months postoperatively were also observed between MH group and the other two groups. A significant difference in the change of HOA from the baseline to 1 month postoperatively was observed between ERM and PDR group however, the difference disappeared at 3 months. Conclusion. 27-gauge vitrectomy did not induce substantial changes in the corneal topographic conditions.
Purpose:To study the relationship between morphologic findings using spectral domain optical coherence tomography and surgical outcomes in patients with submacular hemorrhage (SMH) secondary to age-related macular degeneration.Methods:Medical charts of nine eyes of nine patients who underwent tissue plasminogen activator-assisted vitrectomy for SMH secondary to age-related macular degeneration were retrospectively reviewed. The preoperative height and lateral width of both SMH and pigment epithelial detachment documented with optical coherence tomography, were measured. The status of ellipsoid layers was also analyzed.Results:Complete displacement of SMH from the fovea was achieved in all nine eyes. The preoperative status of the ellipsoid layer under the fovea was detectable in four eyes and absent in the remaining five eyes. Postoperative best-corrected visual acuity was significantly better in eyes with preoperative detectable ellipsoid layers (P < 0.01). Eyes with preoperative SMH heights <400 m also exhibited better best-corrected visual acuity (P < 0.05). There was no significant correlation between postoperative best-corrected visual acuity and the specific features of pigment epithelial detachment, including height, lateral width, and number.Conclusion:The preoperative presence of detectable ellipsoid layers and a lower height of SMH may predict good visual prognosis. In contrast, no specific features of pigment epithelial detachment correlated with postoperative best-corrected visual acuity.
Age-related macular degeneration (AMD) is a leading cause of vision loss in developed countries. Polypoidal choroidal vasculopathy (PCV) is a subtype of AMD characterized by polypoidal lesions and a branching vascular network visualized with indocyanine green angiography. Although the first-line treatment for AMD is well-established, the optimal treatment for PCV can differ from that of AMD and remains under debate. 1 Kokame G.T. Polypoidal choroidal vasculopathy-an important diagnosis to make with therapeutic implications. Retina. 2012; 32: 1446-1448 Crossref PubMed Scopus (28) Google Scholar Re: Oishi et al.: LAPTOP study: a 24-month trial of verteporfin versus ranibizumab for polypoidal choroidal vasculopathy (Ophthalmology 2014;121:1151-2)OphthalmologyVol. 122Issue 1PreviewIn a recent article, Oishi et al1 discussed the 24-month results of the Ranibizumab (Lucentis) And Photodynamic Therapy On Polypoidal choroidal vasculopathy (LAPTOP) study, and reported that patients with polypoidal choroidal vasculopathy (PCV) who were randomized to the ranibizumab arm experienced a gain in visual acuity (VA), while those in the photodynamic therapy (PDT) arm did not show improvement in VA. Full-Text PDF