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Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. We report primary results of two phase 3 trials evaluating intravitreal faricimab with extension up to every 16 weeks for neovascular age-related macular degeneration (nAMD).TENAYA and LUCERNE were randomised, double-masked, non-inferiority trials across 271 sites worldwide. Treatment-naive patients with nAMD aged 50 years or older were randomly assigned (1:1) to intravitreal faricimab 6·0 mg up to every 16 weeks, based on protocol-defined disease activity assessments at weeks 20 and 24, or aflibercept 2·0 mg every 8 weeks. Randomisation was performed through an interactive voice or web-based response system using a stratified permuted block randomisation method. Patients, investigators, those assessing outcomes, and the funder were masked to group assignments. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48 (prespecified non-inferiority margin of four letters), in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (TENAYA NCT03823287 and LUCERNE NCT03823300).Across the two trials, 1329 patients were randomly assigned between Feb 19 and Nov 19, 2019 (TENAYA n=334 faricimab and n=337 aflibercept), and between March 11 and Nov 1, 2019 (LUCERNE n=331 faricimab and n=327 aflibercept). BCVA change from baseline with faricimab was non-inferior to aflibercept in both TENAYA (adjusted mean change 5·8 letters [95% CI 4·6 to 7·1] and 5·1 letters [3·9 to 6·4]; treatment difference 0·7 letters [-1·1 to 2·5]) and LUCERNE (6·6 letters [5·3 to 7·8] and 6·6 letters [5·3 to 7·8]; treatment difference 0·0 letters [-1·7 to 1·8]). Rates of ocular adverse events were comparable between faricimab and aflibercept (TENAYA n=121 [36·3%] vs n=128 [38·1%], and LUCERNE n=133 [40·2%] vs n=118 [36·2%]).Visual benefits with faricimab given at up to 16-week intervals demonstrates its potential to meaningfully extend the time between treatments with sustained efficacy, thereby reducing treatment burden in patients with nAMD.F Hoffmann-La Roche.

To compare the outcomes of vitrectomy with fovea-sparing internal limiting membrane peeling (FSIP) and complete internal limiting membrane peeling (ILMP) for myopic traction maculopathy (MTM). A retrospective, observational study. In this study, we included 22 eyes of 21 consecutive patients who underwent vitrectomy with FSIP or ILMP for MTM and were monitored for at least 6 months. Eleven eyes were treated with FSIP, and 11, with ILMP. With FSIP, the postoperative best-corrected visual acuity (BCVA) significantly improved from 0.61 (20/82) to 0.34 (20/44; P = .009) logarithm of the minimum angle of resolution (logMAR) units. With ILMP, the postoperative BCVA improved from 0.65 (20/89) to 0.52 (20/66) logMAR units, but was not significant (P = .106). The postoperative final central foveal thickness (CFT) reduced significantly after FSIP (from 557.6 to 128.8 µm, P = .003) and ILMP (from 547.3 to 130.3 µm, P = .008). The postoperative incidence of a macular hole was 0% (0/11 eyes) with FSIP and 27.3% (3/11 eyes) with ILMP. All patients with a macular hole had foveal detachment in association with a thin fovea preoperatively. With ILMP, postoperative BCVA with a macular hole worsened by −3.5 letters; in contrast, postoperative BCVA without a macular hole improved by +10.5 letters. With FSIP, postoperative BCVA without a macular hole significantly improved by +13.5 letters (P = .009). FSIP resulted in significant improvement in MTM and prevented postoperative macular hole development.

To examine the influence of inverted internal limiting membrane (ILM) flap technique on the outer retinal layer structures after macular hole (MH) surgery.We included 24 eyes of 24 patients who underwent vitrectomy for large MHs (≥400 µm) with successful MH closure and observed for at least 6 months. Fourteen eyes were treated with inverted ILM flap technique (inverted group) and 10 with conventional ILM peeling (ILMP group). We evaluated the postoperative recovery rate of the external limiting membrane and ellipsoid zone and the best-corrected visual acuity.The postoperative recovery rates of the external limiting membrane and ellipsoid zone in the inverted group were lower than those in the ILMP group (21.4 vs. 70.0%, P = 0.024; 0 vs. 30.0, P = 0.059, respectively). The external limiting membrane recovery period in the inverted group was significantly longer than that in the ILMP group (11.0 ± 1.7 vs. 3.4 ± 2.8 months, P = 0.015). The best-corrected visual acuity change (letters) in the inverted group was significantly smaller than that in the ILMP group (9.0 vs. 22.5, P = 0.040).The poorer anatomical and visual results associated with inverted ILM flap compared with ILM peeling suggest the limitation of the ILM flap technique to repair refractory MHs.

To compare the effects of inverted internal limiting membrane (ILM) flap technique and ILM insertion technique for large macular hole (MH) on glial proliferation, retinal outer layer restoration, and visual function. This retrospective, observational study included 25 eyes with large MH (minimum diameter, ≥ 400 μm) treated using the inverted ILM flap or insertion technique. The inverted flap group was defined as flipping the ILM upside down on the MH (13 eyes) and the insertion group as inserting multiple ILM layers into the MH (12 eyes). Glial proliferation in the photoreceptor layer at 1 month and the final visit was significantly less frequent in the inverted flap group than in the insertion group (61.5% vs. 100%, p = 0.039; 23.1% vs. 100%, p = 0.001). The mean postoperative external limiting membrane defect was 140.4 ± 286.2 μm in the inverted flap group, significantly narrower than that in the insertion group (364.6 ± 181.6 μm; p = 0.016). The mean postoperative ellipsoid zone defect was 235.3 ± 214.2 μm in the inverted flap group, which was almost significantly narrower than that in the insertion group (496.3 ± 445.6 μm; p = 0.068). The change in the best-corrected visual acuity was significantly better in the inverted flap group than that in the insertion group (+ 18.5 vs. + 9.0 letters). Compared with patients treated with the insertion technique, those treated with the inverted ILM flap technique had significantly less glial proliferation at the photoreceptor space, more preferable outer retinal formation, and better visual improvement.

Knowledgeof the choroidal structures in eyes with diabetes and diabetic retinopathy (DR) should provide information on the pathogenesis of DR. A prospective study was performed to determine the systemic and ocular factors that affect the choroidal structures in eyes with diabetes. Two-hundred consecutive diabetic subjects consisted of 160 treatment-naïve patients with different stages of DR and 40 patients with proliferative DR with prior panretinal photocoagulation (PRP). All underwent blood and urine tests and enhanced depth imaging optical coherence tomography (EDI-OCT). The cross-sectional EDI-OCT images of the subfoveal choroid were binarized to measure the total choroidal area (TCA), luminal area, and stromal area. Multivariate regression analyses were performed to determine the systemic and ocular factors that were significantly correlated with the choroidal structures. The subfoveal choroidal thickness, TCA, luminal area, and stromal area were larger at more advanced stage of DR, and smaller in eyes with PRP than those without (P P = 0.034, P = 0.025, respectively). The choroidal lumen and stroma may increase as the stages of DR progress and decrease after PRP. Albuminuria may be associated with the choroidal stromal edema.

To determine the 2-year results of metamorphopsia, visual acuity, and optical coherence tomographic (OCT) parameters after epiretinal membrane (ERM) removal, and to evaluate the correlations among them.We studied 75 eyes of 75 patients with an ERM who underwent vitrectomy and membrane peeling. The best-corrected visual acuity (BCVA), metamorphopsia scores, and OCT parameters were measured at the baseline, and 1, 3, 6, 9, 12, 18, and 24 months postoperatively. M-CHARTS were used to quantify the degree of metamorphopsia.The mean BCVA, degree of metamorphopsia, and all of the OCT parameters except the photoreceptor outer segment (PROS) length improved significantly from that at the baseline at 24 months (P 0.001). However, they were not significantly different from those at 12 months. The better BCVA at 24 months was correlated with the longer PROS length at the baseline (P 0.01). The degree of metamorphopsia at 24 months was significantly correlated with that at baseline (P 0.01).A postoperative follow-up period of 12 months may be sufficient to assess the improvements induced by the ERM surgery. The preoperative PROS length was the prognostic factor for the postoperative BCVA. The preoperative degree of metamorphopsia was the prognostic factor for the postoperative degree of metamorphopsia, suggesting that surgery for ERM should be performed before development of severe metamorphopsia.

Aims To determine the effects of dynamic exercise on the circulation and the luminal and stromal areas of the choroid in normal eyes. Methods This was a prospective interventional study of 38 eyes of 38 normal subjects enrolled by invitation. The systolic and diastolic blood pressures, heart rate, intraocularpressure, mean ocular perfusion pressure (MOPP), choroidal blood velocity, and enhanced depth imaging optical coherence tomographic (EDI-OCT) images were recorded before, and immediately after mild dynamic exercise. The same measurements were recorded after 10 min of rest. The choroidal blood velocity was measured bylaser speckle flowgraphy, and the mean blur rate was used for the evaluations. The horizontal EDI-OCT images of the subfoveal choroid were converted to binary images. The central choroidal thickness (CCT), total cross sectional choroidal area, luminal areas, stromal areas, and the ratio of luminal area to total choroidal area (L/C ratio) were determined from these images. Results The systolic and diastolic blood pressures, heart rate, MOPP, and the mean blur rate were significantly increased immediately after the exercise and significantly decreased 10 minutes after the exercise. There wereno significant changes in the mean CCT, the mean total choroidal area, the mean luminal and stromal areas, and the mean L/C ratio after the exercise. Conclusions Our results suggest that a rest period is needed before measurements of blood flow velocity but not necessary for the EDI-OCT imaging to determine the choroidal thickness and area.

Purpose To report four cases of macular hole formation following ruptured retinal arterial macroaneurysm. Design Case-control study. Methods Review of clinical records of 75 consecutive eyes (73 patients) with macroaneurysm. Macroaneurysms were confirmed using either fluorescein angiography or indocyanine green angiography or both that indicated a telangiectatic retinal vascular change. Clinical data of patients with macroaneurysm with and without macular hole (MH) formation were compared retrospectively. Results Of 75 eyes, four (5.3%; four patients) with macroaneurysm had a macular hole. In one of the four eyes, a macular hole was detected 2 days after the rupture. The distance from the macroaneurysm to the center of the fovea was significantly closer in the four eyes with a macular hole (MH group, 1.1 ± 0.4 (mean ± standard deviation [SD]) disk diameter) than in the 71 eyes without a macular hole (non-MH group, 1.9 ± 0.9 disk diameter) ( P = .0196). The incidence of subretinal hemorrhage in the macula was significantly greater in the MH group (100%) than in the non-MH group (35.2%) ( P = .0195). Conclusions Macular hole formation associated with ruptured macroaneurysm is not as uncommon as previously thought. We suggest that there might be early onset of macular hole formation following ruptured macroaneurysm. Macroaneurysms with early-onset macular hole are present near the center of the macula and are accompanied by subretinal hemorrhage in the macula.

To investigate the clinical characteristics and accompanying macular lesions in Japanese patients with basal laminar drusen (BLD).Retrospective cross-sectional study.Fifty four eyes of 27 Japanese patients with BLD were examined for the clinical characteristics of BLD and accompanying macular lesions using retro-mode imaging (Scanning Laser Ophthalmoscope F-10, Nidek) in addition to current methods such as fluorescein angiography (FA), indocyanine green angiography (IA), fundus autofluorescence (FAF) and spectral domain optical coherence tomography (SD-OCT).1)BLD was more clearly identified using retro-mode imaging than any of the other current imaging methods, and was divided into two types: a crater type (relatively sparsely distributed BLD with many soft drusens) and a mesh type (uniformly distributed BLD). 2) BLD in both eyes was more common in female patients, and had the same type, distribution and similar macular lesions in both eyes. 3) Among the macular lesions, we observed macular atrophy, retinal angiomatous proliferation and vitelliform detachment in many patients, in contrast to few cases of choroidal neovascularization and no polypoidal choroidal vasculopathy.BLD may be regarded as a disease that is different from age-related macular degeneration (AMD).

Using the Retro-mode (RM), to detect drusen and other minute lesions of the retinal pigment epithelium (RPE) invisible in current imaging methods in the fellow eye of Japanese patients with exudative age-related macular degeneration(AMD).A retrospective cross-sectional study.The fellow eyes of nineteen Japanese patients with unilateral exudative AMD were examined using RM imaging (F-10 fundus camera, Nidek), in contrast with fluorescein angiography, indocyanine green angiography, and optic coherence tomography (3D OCT-1000, Topcon Co). We were able to identify the type of drusen and minute granular lesions (MGLs) in the RPE.In all patients, RM imaging gave easier to identify images of all types of drusen than other current imaging methods. Moreover, MGLs of the RPE either adjacent to drusen or without drusen, invisible in other current methods, were detected by RM imaging.The RM provides clearer imaging of all kind of drusen, and MGLs of the RPE invisible with current methods. These MGLs are possible precursors of drusen.

PURPOSE To follow the changes in the metamorphopsia, visual acuity, and OCT parameters after epiretinal membrane (ERM) removal. METHODS The study included 49 eyes of 49 patients with an ERM who underwent vitrectomy and membrane peeling. The changes in the best-corrected visual acuity (BCVA), metamorphopsia, and central foveal thickness (CFT) were evaluated at baseline and 1, 3, 6, 9, and 12 months postoperatively. M-CHARTS were used to quantify metamorphopsia. RESULTS The mean BCVA, metamorphopsia scores for horizontal lines (MH) and vertical lines (MV), and CFT improved significantly at 12 months after surgery (P < 0.001). The baseline BCVA, MH score, and MV score were significantly correlated with the corresponding BCVA, MH score, and MV score at 12 months after surgery (P < 0.01). The MH and MV scores at 12 months was significantly correlated with the BCVA at 12 months (P < 0.01), and the baseline MV score was significantly correlated with the BCVA at 12 months (P < 0.05). The MH score but not the MV score was significantly correlated with the CFT at baseline and 12 months (P < 0.05). CONCLUSIONS The preoperative BCVA, MH score, and MV score were prognostic factors for the corresponding postoperative BCVA, MH score, and MV score. These results suggest that surgery for ERM should be considered before severe reduction in the BCVA or the degree of metamorphopsia. In addition, the preoperative MV score was a prognostic factor for postoperative BCVA. The MH score but not the MV score was correlated with the CFT preoperatively and postoperatively.

To study the clinical features of vitreous hemorrhage (VH) after photodynamic therapy (PDT) for age-related macular degeneration(AMD).Twelve patients (12 eyes: 1.7% of the 718 eyes on which PDT was performed) who had vitrectomy due to massive VH after PDT for AMD were studied. Their medical records were reviewed and courses and characteristics were studied.Eight eyes (67%) were diagnosed as polypoidal choroidal vasculopathy and 7 eyes showed multiple clusters of grape-like lesions. Average greatest linear dimension (GLD) was 4533 microm, larger than common AMD. After vitrectomy, some cases retained choroidal neovascularization. Five eyes had another PDT and 3 eyes had a second vitrectomy due to recurrent vitreous hemorrhage.Both PCV and a large GLD are risk factors for a massive vitreous hemorrhage after PDT therapy for AMD. As many cases retain choroidal neovascularization many patients require additional treatment. Continued observation after vitrectomy is essential.

To study the visualization of the vitreoretinal interface in diabetic macular edema patients using three-dimensional optical coherence tomography (3 D-OCT) and to compare it to surgical findings.We prospectively examined the medical records of 25 patients (30 eyes) with diabetic macular edema measured by 3 D-OCT (optic disc and macular lesions) who received vitrectomy between August 2006 and February 2007. We compared the findings of 3 D-OCT to the findings during surgery using triamcinolone acetonide.Posterior vitreous membrane was found in 18 eyes using 3 D-OCT. The findings in all cases corresponded to operative findings. Six cases were characterized by posterior vitreous membrane attached to the optic disc and macular area. Twelve cases were characterized by posterior vitreous membrane diffusely attached to the posterior pole.Vitreoretinal interfaces were visualized using 3D-OCT and confirmed by operative findings. 3 D-OCT is an effective tool to determine the pathogenesis of diabetic macular edema.

We treated a patient with multifocal choroiditis (MFC) associated with serpiginous choroiditis and choroidal neovascularization (CNV).In a 27-year-old woman whose left eye showed serpiginous choroiditis near the optic disc and multiple irregular chorioretinal scars and exudates in peripheral and near-peripheral zones, fluorescein angiography demonstrated diffusely scattered hyperfluorescent dots and late leakage from retinal vessels. The lesion near the optic disc showed hypofluorescence in the early venous phase, and hyperfluorescence in the late phase. Sub-Tenon injection of triamcinolone acetonide did not effectively treat the CNV secondary to serpiginous choroiditis, but direct laser photocoagulation was successful, achieving improved visual acuity.We suggest that this patient's MFC and serpiginous choroiditis represented a single process rather than independent events. With lesions at the posterior pole, CNV developed secondarily. In this case, direct laser photocoagulation proved useful.

To study the outcome after vitrectomy for chronic and acute macular edema associated with branch retinal vein occlusion (BRVO).Medical charts of fifty-five patients (55 eyes) who underwent vitrectomy for macular edema associated with BRVO were reviewed retrospectively. Patients were followed up for more than one year after the vitrectomy. We compared the visual and structural outcome between an early group (i. e., edema lasting less than one year) and a late group (i.e., edema lasting more than one year).The mean visual acuity improved significantly from 0.088 to 0.163 in the early group and from 0.147 to 0.132 in the late group. Seventy percent of the cases improved in angiographic findings and eighty percent of the cases improved in optical coherence tomography findings.Vitrectomy for chronic macular edema even lasting more than one year after BRVO seems to be effective, depending on the case.

To study the factors for poor visual outcome in photodynamic therapy(PDT) for age-related macular degeneration (AMD) patients with subfoveal choroidal neovascularization.Medical charts of eighty-five patients (88 eyes) who had AMD with subfoveal choroidal neovascularization were reviewed in the study. All patients were followed up by visual acuity assessment, angiography, and optical coherence tomography at least 6 months after PDT.Out of 11 cases of poor visual outcome, 7 cases showed cystoid macular edema (CME) before treatment and 4 cases showed massive subretinal hemorrhage and/or vitreous hemorrhage after treatment. Some cases with CME had a worse visual outcome than cases without CME.Some of the factors for poor visual outcome after PDT for AMD are the existence of CME before treatment and polypoidal choroidal vasculopathy (PCV). In some cases, PCV caused massive subretinal hemorrhage and/or vitreous hemorrhage after treatment.

To evaluate the effects of photodynamic therapy (PDT) with verteporfin 1 year after treatment in Japanese patients with age-related macular degeneration (AMD) and subfoveal choroidal neovascularization.Between May 2004 and March 2005, PDT was performed on 102 eyes of 98 patients (60 men and 38 women) with AMD and subfoveal choroidal neovascularization. Patients were followed for at least 12 months after PDT.The mean visual acuities in logarithm of the minimum angle of resolution (logMAR) units were 0.978 at baseline, 0.919 at 3 months, 0.895 at 6 months, 0.892 at 9 months, and 0.874 at 12 months. After PDT, the logMAR visual acuity improved by0.3 logMAR units or more in 28 eyes (27%) and deteriorated by0.3 logMAR units or more in 13 eyes (13%). Stable or improved vision was achieved in 93% of patients with polypoidal choroidal vasculopathy (PCV).The visual outcome in our patients was similar to that of an earlier major Japanese study, and similar to or better than outcomes in Western studies. Differences between Caucasians and Japanese might influence the characteristics of PCV. It is possible that PDT is more effective for AMD patients with PCV than for other AMD patients. Further observations and longer follow-up are necessary.

Background: We encountered a patient who developed serous retinal detachment in one eye first, subsequently showed multiple small subretinal punctated opacity looking like acute posterior multifocal placoid pigment epitheliopathy (APMPPE) in both eyes, and had repeated recurrence. Case: A 28-year-old female presented with serous retinal detachment accompanied by multifocal small subretinal white punctated opacity at the posterior pole of the fundus in the left eye. Fluorescein angiography (FAG) revealed many small punctated hypofluorescent lesions scattered all over the eye in the early stage and multiple subretinal spotty leakage of fluorescein, subretinal accumulation of dye, and leakage of fluorescein from the optic disc in the late stage. Indocyanine green angiography (ICG) revealed small punctated hypofluorescent lesions from the early to late stage in both eyes. The disease recurred five and a half months after, and there appeared many yellowish white round opaque parts and serous retinal detachment at the posterior pole in both eyes. FAG showed a reversal phenomenon of fluorescein in both eyes. On ICG many small punctated hypofluorescent lesions were noted and in the late stage insular faint hypofluorescence consistent with serous retinal detachment, light tissue stain and fluorescent leakage in the center of the hypofluorescent lesion were also found. The disease recurred three times thereafter. At present, about two years after the first medical examination, the fundus does not show any sunset glow-like fundus, and vision of 1.2 is maintained on the right and left. Conclusion: A rare case of Harada disease complicated with APMPPE-like recurrence is presented.