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1.
J Clin Med ; 13(16)2024 Aug 08.
Artículo en Inglés | MEDLINE | ID: mdl-39200783

RESUMEN

Objectives: To evaluate the one-year outcomes of intravitreal ranibizumab biosimilar (RBZ-BS) injections for myopic choroidal neovascularization (mCNV) in Japanese patients. Methods: Twenty-one patients (mean age 69.0 years; 4 males, 17 females) with high myopia and mCNV were retrospectively reviewed. Twelve were treatment-naïve, and nine had previous anti-VEGF treatments. Efficacy measures included best-corrected visual acuity (BCVA) and central macular thickness (CMT). Results: The treatment-naïve group showed significant BCVA improvement from 0.55 ± 0.34 at baseline to 0.24 ± 0.28 at 12 months. The previously treated group had no significant BCVA changes. CMT significantly decreased in both groups: from 295.3 ± 105.2 µm to 207.3 ± 63.0 µm in the treatment-naïve group, and from 196.1 ± 62.0 µm to 147.2 ± 50.1 µm in the previously treated group. Dry macula rates were high: 83% at 3 months and 83% at 12 months in the treatment-naïve group, and 67% at 3 months and 89% at 12 months in the previously treated group. No adverse events were reported. Conclusions: These findings indicate that RBZ-BS is an effective and safe treatment for mCNV, particularly in treatment-naïve patients. The use of RBZ-BS offers a cost-effective alternative to original ranibizumab, reducing financial burdens while maintaining high therapeutic efficacy. Further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and evaluate long-term outcomes and cost-effectiveness.

2.
J Clin Med ; 13(15)2024 Jul 26.
Artículo en Inglés | MEDLINE | ID: mdl-39124642

RESUMEN

Objective: To purpose of this study was to retrospectively evaluate the 1-year outcomes and factors associated with the treatment responsiveness of switching to intravitreal brolucizumab (IVBR) for neovascular age-related macular degeneration (nAMD) in Japanese patients refractory to ranibizumab or aflibercept using a treat and extend (TAE) regimen. Methods: A total of 48 eyes of 47 nAMD patients were switched to IVBR, and 36 eyes of 35 patients (27 males and 8 females) underwent 1-year treatment after the switch. Results: The rate of dry macula was significantly higher 12 months after the switch to IVBR (p < 0.001), with a significant decrease in the mean central macular thickness (CMT) and the mean central choroidal thickness (CCT) (p < 0.01 and p < 0.01, respectively). The injection interval was significantly extended from 7.0 ± 1.7 weeks to 10.3 ± 2.5 weeks 12 months after the switch (p < 0.001). In the multivariate analysis, a smaller number of prior anti-VEGF injections (p = 0.025; odds ratio: 0.947; 95% confidence interval: 0.903-0.994) and a pre-switching CCT of less than 250 µm (p = 0.023; odds ratio: 0.099; 95% confidence interval: 0.013-0.731) were associated with the good response group. Conclusions: These results suggest that IVBR may suppress disease activity and prolong the injection interval by switching for AMD patients with an insufficient response to treatment with ranibizumab and aflibercept.

3.
J Clin Med ; 13(11)2024 May 31.
Artículo en Inglés | MEDLINE | ID: mdl-38892980

RESUMEN

Objectives: Our purpose was to examine the effectiveness of pattern scanning laser trabeculoplasty (PSLT) as an additional treatment for patients of open-angle glaucoma (OAG) receiving maximized ocular hypotensive medications (OHM). Methods: A total of 40 eyes of 33 patients (average age 72.7 ± 10.7 years) who had not previously undergone open glaucoma surgery or laser trabeculoplasty and were treated with maximized OHM between June 2018 and March 2022 were included. A 360-degree PSLT was conducted, and postoperative intraocular pressure (IOP) and survival curves at 1, 3, 6, 9, and 12 months were evaluated. Results: According to the Kaplan-Meier survival analysis, the average survival time was 8.1 months and the survival rate at 12 months was 0.55, with death defined as postoperative IOP reduction of less than 10% or requiring additional treatment. The average survival time was 4.9 months and the survival rate at 12 months was 0.28, with death defined as postoperative IOP reduction of less than 20% or requiring additional treatment. Nine eyes showed increased IOP (three eyes) or worsened visual field (six eyes) during the course and underwent additional open glaucoma surgery. In the 31 eyes which received no additional treatment after PSLT, the mean preoperative IOP was 18.5 ± 3.9 mmHg, which reduced to 15.3 ± 4.1 mmHg (p = 1.62 × 10-6), 15.5 ± 3.4 mmHg (p = 1.51 × 10-5), 15.7 ± 4.0 mmHg (p = 1.75 × 10-5), 14.7 ± 4.38 (p = 2.89 × 10-6), and 15.0 ± 4.0 mmHg (p = 5.74 × 10-9) at 1, 3, 6, 9, and 12 months after PSLT, respectively. The IOP reduction rate one year after PSLT was 18.7%. Of the 31 eyes, 13 (42%) achieved a 20% reduction in IOP compared to the baseline. Conclusions: Adjunctive treatment with PSLT in OAG patients receiving maximized OHM may be effective over 12 months of follow-up.

4.
Am J Ophthalmol Case Rep ; 35: 102078, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38846070

RESUMEN

Purpose: Anti-vascular endothelial growth factor (VEGF) therapy is the most prevalent intervention for exudative lesions secondary to neovascular age-related macular degeneration (nAMD) and other macular neovascularization (MNV). However, in some cases refractory to the latest anti-VEGF agents is associated with epiretinal membrane (ERM) or vitreomacular traction. We applied a vitrectomy to remove those pathologies which may be effective for reducing the exudation. Observations: In this case report, we present 2 cases with sustained subretinal fluid and macular neovascularization secondary to nAMD or dome-shaped macula that poorly responded to anti-VEGF therapy. In both cases, removing thin ERM or vitreomacular traction with an inner limiting membrane peeling promptly resolved the subretinal fluid and no recurrence was observed thereafter. Conclusions and importance: Vitrectomy could be an effective modality for anti-VEGF drug-resistant MNV cases with vitreomacular traction or ERM even in the anti-VEGF era.

5.
Artículo en Inglés | MEDLINE | ID: mdl-38700592

RESUMEN

PURPOSE: To investigate the possibility of distinguishing between IgG4-related ophthalmic disease (IgG4-ROD) and orbital MALT lymphoma using artificial intelligence (AI) and hematoxylin-eosin (HE) images. METHODS: After identifying a total of 127 patients from whom we were able to procure tissue blocks with IgG4-ROD and orbital MALT lymphoma, we performed histological and molecular genetic analyses, such as gene rearrangement. Subsequently, pathological HE images were collected from these patients followed by the cutting out of 10 different image patches from the HE image of each patient. A total of 970 image patches from the 97 patients were used to construct nine different models of deep learning, and the 300 image patches from the remaining 30 patients were used to evaluate the diagnostic performance of the models. Area under the curve (AUC) and accuracy (ACC) were used for the performance evaluation of the deep learning models. In addition, four ophthalmologists performed the binary classification between IgG4-ROD and orbital MALT lymphoma. RESULTS: EVA, which is a vision-centric foundation model to explore the limits of visual representation, was the best deep learning model among the nine models. The results of EVA were ACC = 73.3% and AUC = 0.807. The ACC of the four ophthalmologists ranged from 40 to 60%. CONCLUSIONS: It was possible to construct an AI software based on deep learning that was able to distinguish between IgG4-ROD and orbital MALT. This AI model may be useful as an initial screening tool to direct further ancillary investigations.

6.
Graefes Arch Clin Exp Ophthalmol ; 262(8): 2439-2448, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38483611

RESUMEN

PURPOSE: To evaluate 2-year efficacy, durability, and safety of faricimab in the TENAYA Japan subgroup and pooled global TENAYA/LUCERNE cohort of patients with neovascular age-related macular degeneration (nAMD). METHODS: Subgroup analysis of TENAYA/LUCERNE (NCT03823287/NCT03823300): phase III, multicentre, randomised, active comparator-controlled, double-masked, non-inferiority trials. Treatment-naïve patients aged ≥ 50 years with nAMD were randomised (1:1) to intravitreal faricimab (6.0 mg up to every 16 weeks [Q16W] after 4 initial Q4W doses) or aflibercept (2.0 mg Q8W after 3 initial Q4W doses). Outcomes were assessed through year 2 for the TENAYA Japan subgroup (N = 133) and global pooled TENAYA/LUCERNE cohort (N = 1329). RESULTS: Vision and anatomic improvements achieved with faricimab at year 1 were maintained over 2 years and were generally comparable between the TENAYA Japan subgroup and pooled TENAYA/LUCERNE cohort. Adjusted mean best-corrected visual acuity (BCVA) change from baseline at year 2 for the TENAYA Japan subgroup and global pooled TENAYA/LUCERNE cohort was +7.1 (3.7-10.5) and +4.4 (3.2-5.5) letters in the faricimab arm, respectively, and +5.2 (1.9-8.6) and +4.3 (3.1-5.4) letters in the aflibercept arm, respectively. At week 112, the proportion of faricimab-treated patients on Q16W dosing was 61.0% and 63.1% in the TENAYA Japan subgroup and pooled TENAYA/LUCERNE cohort. Faricimab was well tolerated through year 2. CONCLUSION: Year 2 TENAYA Japan subgroup findings for faricimab were generally consistent with the pooled global TENAYA/LUCERNE results in patients with nAMD. Vision and anatomical benefits with faricimab were similar to those with aflibercept but with fewer injections.


Asunto(s)
Inhibidores de la Angiogénesis , Inyecciones Intravítreas , Receptores de Factores de Crecimiento Endotelial Vascular , Agudeza Visual , Degeneración Macular Húmeda , Humanos , Masculino , Método Doble Ciego , Femenino , Japón/epidemiología , Degeneración Macular Húmeda/tratamiento farmacológico , Degeneración Macular Húmeda/diagnóstico , Degeneración Macular Húmeda/fisiopatología , Resultado del Tratamiento , Persona de Mediana Edad , Anciano , Estudios de Seguimiento , Inhibidores de la Angiogénesis/administración & dosificación , Inhibidores de la Angiogénesis/efectos adversos , Receptores de Factores de Crecimiento Endotelial Vascular/administración & dosificación , Receptores de Factores de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Tomografía de Coherencia Óptica , Proteínas Recombinantes de Fusión/administración & dosificación , Factores de Tiempo , Relación Dosis-Respuesta a Droga , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Esquema de Medicación , Angiografía con Fluoresceína
7.
Graefes Arch Clin Exp Ophthalmol ; 262(9): 2799-2811, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38507046

RESUMEN

Age-related macular degeneration (AMD) is the leading sight-threatening disease in developed countries. On the other hand, recent studies indicated an ethnic variation in the phenotype of AMD. For example, several reports demonstrated that the incidence of drusen in AMD patients is less in Asians compared to Caucasians though the reason has not been clarified yet. In the last decades, several genome association studies have disclosed many susceptible genes of AMD and revealed that the association strength of some genes was different among races and AMD phenotypes. In this review article, the essential findings of the clinical studies and genome association studies for the most significant genes CFH and ARMS2/HTRA1 in AMD of different races are summarized, and theoretical hypotheses about the molecular mechanisms underlying the ethnic variation in the AMD manifestation mainly focused on those genes between Caucasians and Asians are discussed.


Asunto(s)
Predisposición Genética a la Enfermedad , Degeneración Macular , Humanos , Degeneración Macular/genética , Degeneración Macular/etnología , Degeneración Macular/diagnóstico , Estudio de Asociación del Genoma Completo , Factor H de Complemento/genética , Etnicidad/genética , Proteínas/genética , Fenotipo , Polimorfismo de Nucleótido Simple , Pueblo Asiatico/genética , Pueblo Asiatico/etnología , Serina Peptidasa A1 que Requiere Temperaturas Altas/genética
8.
Ophthalmol Ther ; 13(4): 935-954, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38308746

RESUMEN

INTRODUCTION: The EVEREST II study previously reported that intravitreally administered ranibizumab (IVR) combined with photodynamic therapy (PDT) achieved superior visual gain and polypoidal lesion closure compared to IVR alone in patients with polypoidal choroidal vasculopathy (PCV). This follow-up study reports the long-term outcomes 6 years after initiation of the EVEREST II study. METHODS: This is a non-interventional cohort study of 90 patients with PCV from 16 international trial sites who originally completed the EVEREST II study. The long-term outcomes were assessed during a recall visit at about 6 years from commencement of EVEREST II. RESULTS: The monotherapy and combination groups contained 41 and 49 participants, respectively. The change in best-corrected visual acuity (BCVA) from baseline to year 6 was not different between the monotherapy and combination groups; - 7.4 ± 23.0 versus - 6.1 ± 22.4 letters, respectively. The combination group had greater central subfield thickness (CST) reduction compared to the monotherapy group at year 6 (- 179.9 vs - 74.2 µm, p = 0.011). Fewer eyes had subretinal fluid (SRF)/intraretinal fluid (IRF) in the combination versus monotherapy group at year 6 (35.4% vs 57.5%, p = 0.032). Factors associated with BCVA at year 6 include BCVA (year 2), CST (year 2), presence of SRF/IRF at year 2, and number of anti-VEGF treatments (years 2-6). Factors associated with presence of SRF/IRF at year 6 include combination arm (OR 0.45, p = 0.033), BCVA (year 2) (OR 1.53, p = 0.046), and presence of SRF/IRF (year 2) (OR 2.59, p = 0.042). CONCLUSION: At 6 years following the EVEREST II study, one-third of participants still maintained good vision. As most participants continued to require treatment after exiting the initial trial, ongoing monitoring and re-treatment regardless of polypoidal lesion status are necessary in PCV. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01846273.

9.
Front Oncol ; 14: 1277749, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38322414

RESUMEN

Purpose: To examine the molecular biological differences between conjunctival mucosa-associated lymphoid tissue (MALT) lymphoma and orbital MALT lymphoma in ocular adnexa lymphoma. Methods: Observational case series. A total of 129 consecutive, randomized cases of ocular adnexa MALT lymphoma diagnosed histopathologically between 2008 and 2020.Total RNA was extracted from formalin-fixed paraffin-embedded tissue from ocular adnexa MALT lymphoma, and RNA-sequencing was performed. Orbital MALT lymphoma gene expression was compared with that of conjunctival MALT lymphoma. Gene set (GS) analysis detecting for gene set cluster was performed in RNA-sequence. Related proteins were further examined by immunohistochemical staining. In addition, artificial segmentation image used to count stromal area in HE images. Results: GS analysis showed differences in expression in 29 GS types in primary orbital MALT lymphoma (N=5,5, FDR q-value <0.25). The GS with the greatest difference in expression was the GS of epithelial-mesenchymal transition (EMT). Based on this GS change, immunohistochemical staining was added using E-cadherin as an epithelial marker and vimentin as a mesenchymal marker for EMT. There was significant staining of vimentin in orbital lymphoma (P<0.01, N=129) and of E-cadherin in conjunctival lesions (P=0.023, N=129). Vimentin staining correlated with Ann Arbor staging (1 versus >1) independent of age and sex on multivariate analysis (P=0.004). Stroma area in tumor were significant difference(P<0.01). Conclusion: GS changes including EMT and stromal area in tumor were used to demonstrate the molecular biological differences between conjunctival MALT lymphoma and orbital MALT lymphoma in ocular adnexa lymphomas.

10.
PLoS One ; 19(1): e0297201, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38232093

RESUMEN

PURPOSE: To investigate relationship between vitreous interleukin-6 levels and vitreous particles findings on widefield optical coherence tomography in posterior uveitis. METHODS: This retrospective study examined vitreous inflammatory cells (hyperreflective particles) of posterior uveitis on widefield optical coherence tomography (WOCT). We examined the number of hyperreflective particles (possibility of vitreous inflammatory cells) observed on WOCT and the correlations with interleukin-6 (IL-6) levels. The relationship between vitreous IL-6 levels and image findings from WOCT from 37 eyes (34 patients) with posterior uveitis were analyzed. Mean patient age was 63.4±15.7 years. (Mean± standard deviation) IL-6 concentration in vitreous humor was 79.9±7380.9 pg/mL Uveitis was infectious in 9 cases and non-infectious in 28 cases with multiplex polymerase chain reaction system. We measured the number and size of vitreous cells in the posterior vitreous, defined as the space between the upper vitreous and the internal limiting membrane on WOCT at the macular, upper, and lower regions. Image analysis software was also used for cell counting. RESULTS: A strong correlation was seen between human and software counts. Pearson's correlation coefficient (PCC) was performed to compare categorial variables (on macular +0.866; upper cavity +0.713; lower cavity +0.568; total vitreous cavity +0.834; P<0.001 each). IL-6 levels correlated with both vitreous cell counts and cell counts observed on macular WOCT (human-counted group +0.339, P = 0.04; software-counted group +0.349, P = 0.03). Infectious uveitis showed higher IL-6 levels (P = 0.016) and high cell counts compared with non-infectious uveitis (P = 0.04). CONCLUSIONS: Vitreous number of hyperreflective particles (cells) findings on WOCTcorrelated well with human and software cell counts. Vitreous cells findings on WOCT also correlated with IL-6 concentrations on macular.


Asunto(s)
Uveítis Posterior , Uveítis , Humanos , Persona de Mediana Edad , Anciano , Interleucina-6 , Estudios Retrospectivos , Tomografía de Coherencia Óptica/métodos , Uveítis/diagnóstico por imagen , Retina
11.
Case Rep Ophthalmol ; 15(1): 71-77, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38288028

RESUMEN

Introduction: Ocular metastases from breast cancer, particularly involving the optic nerve, are rare and pose a diagnostic challenge. Typically, optic nerve metastases are believed to originate from nearby choroidal metastases or hematogenous spread through the posterior ciliary arteries. However, there have been some reports of metastases through leptomeningeal dissemination. The aim of this report was to describe a case of multiple brain metastases from breast cancer without subjective symptoms other than central scotoma, which was diagnosed with repeated magnetic resonance imaging (MRI). Case Presentation: A 62-year-old woman who had previously undergone a mastectomy for left breast cancer complained of left ocular pain during eye movement and left visual loss. Initial contrast-enhanced MRI showed no significant abnormalities, and idiopathic optic neuritis was suspected. Despite steroid pulse therapy, her visual function did not improve. After four and a half months, her visual acuity worsened, and repeat contrast-enhanced MRI showed brain metastases involving the optic nerve sheath. Conclusion: Despite the multiple brain metastases, ultimately the patient's only symptom was unilateral visual loss. These findings highlight the usefulness of repeated contrast-enhanced MRI for detecting brain metastases, especially in cases without other apparent neurological symptoms or initial imaging abnormalities.

12.
Retina ; 44(4): 714-722, 2024 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-38016089

RESUMEN

PURPOSE: To investigate the incidence of intraocular inflammation (IOI) and its risk factors following intravitreal injections of brolucizumab for neovascular age-related macular degeneration in Japan. METHODS: A total of 1,351 Japanese consecutive patients with neovascular age-related macular degeneration who were treated with brolucizumab from May 2020 to May 2022 at 14 institutions were examined. The variables analyzed were the number of brolucizumab injections, time to onset of IOI, and risk factors. RESULTS: Intraocular inflammation developed in 152 eyes (11.3%). Retinal vasculitis and/or retinal occlusion occurred in 53 eyes (3.9%). Ninety-four patients received bilaterally, bilateral IOI occurred in five patients (5.3%). Sixteen eyes (1.2%) had irreversible visual acuity loss and nine eyes (0.67%) had visual loss of three lines or more due to retinal vasculitis and/or retinal occlusion. The cumulative IOI incidence was 4.5%, 10.3%, and 12.2% at 30, 180, and 365 days (1-year), respectively. History of IOI (including retinal vasculitis) and/or retinal occlusion (odds ratio [OR], 5.41; P = 0.0075) and female sex (OR, 1.99; P = 0.0004) were significantly associated with IOI onset. CONCLUSION: The 1-year cumulative incidence of IOI in Japanese neovascular age-related macular degeneration patients treated with brolucizumab was 12.2%. History of IOI (including retinal vasculitis) and/or retinal occlusion and female sex were significant risk factors.


Asunto(s)
Anticuerpos Monoclonales Humanizados , Degeneración Macular , Vasculitis Retiniana , Uveítis , Femenino , Humanos , Inhibidores de la Angiogénesis , Incidencia , Inflamación , Inyecciones Intravítreas , Japón , Retina , Factores de Riesgo , Trastornos de la Visión , Masculino
13.
Sci Rep ; 13(1): 22981, 2023 12 27.
Artículo en Inglés | MEDLINE | ID: mdl-38151501

RESUMEN

To investigate whether aldosterone (ALD) and hydrocortisone (HC) change the gene expression of SLC7A5, which encodes the large neutral amino acid transporter small subunit 1 (LAT1), and the transport activity of LAT1 in the retinal pigment epithelium (RPE) in vitro. ARPE-19 cells were grown to confluence. After withdrawing the serum, ALD or HC was added with several doses and incubated, and SLC7A5 gene expression was measured. The influx and efflux transport of sodium fluorescein (Na-F) were evaluated using the Transwell culture system. SLC7A5 gene expression was upregulated by ALD and downregulated by HC in a dose-dependent manner. Both ALD and HC significantly increased the influx and efflux Na-F transport of RPE cells at a dose that did not change the expression of SLC7A5. JPH203, a specific inhibitor of LAT1, significantly reduced accelerated Na-F transport. Both ALD and HC increased the gene expression of zonula occludin-1 (ZO-1) although they did not change the immunoreactivity of ZO-1 in RPE cells. LAT1 may play an important role in increasing Na-F transport associated with ALD and HC administration. A specific LAT1 inhibitor may effectively regulate the increased material transport of RPE induced by ALD and HC.


Asunto(s)
Células Epiteliales , Transportador de Aminoácidos Neutros Grandes 1 , Transportador de Aminoácidos Neutros Grandes 1/metabolismo , Fluoresceína , Transporte Biológico , Células Epiteliales/metabolismo , Corticoesteroides , Pigmentos Retinianos/metabolismo
15.
Curr Eye Res ; 48(12): 1195-1202, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37566457

RESUMEN

PURPOSE: The purpose of this study was to develop artificial intelligence algorithms that can distinguish between orbital and conjunctival mucosa-associated lymphoid tissue (MALT) lymphomas in pathological images. METHODS: Tissue blocks with residual MALT lymphoma and data from histological and flow cytometric studies and molecular genetic analyses such as gene rearrangement were procured for 129 patients treated between April 2008 and April 2020. We collected pathological hematoxylin and eosin-stained (HE) images of lymphoma from these patients and cropped 10 different image patches at a resolution of 2048 × 2048 from pathological images from each patient. A total of 990 images from 99 patients were used to create and evaluate machine-learning models. Each image patch of three different magnification rates at ×4, ×20, and ×40 underwent texture analysis to extract features, and then seven different machine-learning algorithms were applied to the results to create models. Cross-validation on a patient-by-patient basis was used to create and evaluate models, and then 300 images from the remaining 30 cases were used to evaluate the average accuracy rate. RESULTS: Ten-fold cross-validation using the support vector machine with linear kernel algorithm was identified as the best algorithm for discriminating between conjunctival mucosa-associated lymphoid tissue and orbital MALT lymphomas, with an average accuracy rate under cross-validation of 85%. There were ×20 magnification HE images that were more accurate in distinguishing orbital and conjunctival MALT lymphomas among ×4, ×20, and ×40. CONCLUSION: Artificial intelligence algorithms can successfully distinguish HE images between orbital and conjunctival MALT lymphomas.


Asunto(s)
Neoplasias de la Conjuntiva , Neoplasias del Ojo , Linfoma de Células B de la Zona Marginal , Humanos , Linfoma de Células B de la Zona Marginal/genética , Inteligencia Artificial , Neoplasias de la Conjuntiva/diagnóstico , Neoplasias de la Conjuntiva/patología , Aprendizaje Automático
17.
Jpn J Ophthalmol ; 67(3): 301-310, 2023 May.
Artículo en Inglés | MEDLINE | ID: mdl-37039948

RESUMEN

PURPOSE: To evaluate the 1-year efficacy, durability, and safety of faricimab versus aflibercept in patients with neovascular age-related macular degeneration (nAMD) enrolled in the Japan subgroup of the TENAYA trial. STUDY DESIGN: TENAYA (NCT03823287) was a global, phase 3, multicenter, randomized, active comparator-controlled, double-masked, noninferiority, parallel-group, 112-week trial. After completion of global enrollment, additional patients were enrolled in the Japan extension of TENAYA. METHODS: Treatment-naïve patients aged ≥ 50 years with nAMD were randomized (1:1) to intravitreal faricimab 6 mg up to every 16 weeks (Q16W) after 4 initial Q4W doses based on disease activity at weeks 20 and 24 or aflibercept 2 mg Q8W after 3 initial Q4W doses. Primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48. Anatomical/durability outcomes were assessed. RESULTS: Overall, 133 patients were included in the TENAYA Japan subgroup analysis (faricimab, n = 66; aflibercept, n = 67). The adjusted mean (95% confidence interval) BCVA changes were + 7.1 (4.6‒9.7) and + 7.7 (5.2‒10.1) letters in the faricimab and aflibercept treatment groups, respectively. At week 48, 66.1%, 22.6%, and 11.3% of patients in the faricimab group were on Q16W, Q12W, Q8W and dosing intervals, respectively. Ocular adverse event rates were similar between treatment groups (faricimab, n = 14 [21.2%] versus aflibercept, n = 17 [25.4%]). CONCLUSION: The TENAYA Japan subgroup analysis showed that faricimab up to Q16W had sustained efficacy with an acceptable safety profile. These findings are consistent with the global TENAYA and LUCERNE findings.


Asunto(s)
Degeneración Macular , Degeneración Macular Húmeda , Humanos , Inhibidores de la Angiogénesis , Japón/epidemiología , Agudeza Visual , Inyecciones Intravítreas , Receptores de Factores de Crecimiento Endotelial Vascular , Degeneración Macular/tratamiento farmacológico , Proteínas Recombinantes de Fusión , Resultado del Tratamiento , Degeneración Macular Húmeda/diagnóstico , Degeneración Macular Húmeda/tratamiento farmacológico
18.
Jpn J Ophthalmol ; 67(3): 295-300, 2023 May.
Artículo en Inglés | MEDLINE | ID: mdl-36867256

RESUMEN

PURPOSE: Persistent central serous chorioretinopathy (pCSC) may be treated by laser photocoagulation (PC), selective retina therapy (SRT), or photodynamic therapy (PDT). We conducted retrospective analyses regarding the choice of therapy for pCSC in the best clinical practice and the outcomes of these modalities. STUDY DESIGN: A retrospective interventional study. METHODS: The records of 71 eyes of 68 treatment naïve pCSC cases who underwent PC, SRT, or PDT were reviewed. First, the baseline clinical parameters were evaluated to find significant factors associated with the choice of treatment option. Second, the 3 months' visual and anatomical outcomes of each modality were assessed. RESULTS: The PC, SRT, and PDT groups included 7, 22, and 42 eyes, respectively. The leakage pattern in fluorescein angiography (FA) was significantly associated with the choice of treatment (p<0.005). The dry macula ratio at 3 months post-treatment was 29%, 59%, and 81% in the PC, SRT, and PDT groups, respectively, which significantly differed among the groups (p<0.01). The best-corrected visual acuities tended to be improved after the treatments in all groups. Central choroidal thickness (CCT) was significantly decreased in all groups (p<0.05, p<0.01, and p<0.00001, in PC, SRT, and PDT groups, respectively). Logistic regression analysis for dry macula revealed that SRT (p<0.05), PDT (p<0.05), and the changes in CCT (p<0.01)were the significant association factors. CONCLUSION: The leakage pattern in FA was associated with the choice of treatment option for pCSC. PDT achieved a significantly higher dry macula ratio than PC, 3 months after the treatment.


Asunto(s)
Coriorretinopatía Serosa Central , Fotoquimioterapia , Porfirinas , Humanos , Coriorretinopatía Serosa Central/terapia , Coriorretinopatía Serosa Central/tratamiento farmacológico , Fármacos Fotosensibilizantes/uso terapéutico , Estudios Retrospectivos , Agudeza Visual , Angiografía con Fluoresceína , Tomografía de Coherencia Óptica , Enfermedad Crónica
19.
J Clin Med ; 12(5)2023 Feb 21.
Artículo en Inglés | MEDLINE | ID: mdl-36902507

RESUMEN

This study retrospectively determined the relationship between vitreous IL-6 levels and clinical and laboratory data collected from uveitis patients. We examined an unknown cause of posterior uveitis, collecting vitreous fluid to investigate vitreous IL-6 levels. The samples were analyzed in consideration of clinical and laboratory factors, such as the male/female ratio. The present study included 82 eyes from 77 patients with a mean age of 66.20 ± 15.41 years. The IL-6 concentrations of the vitreous specimens were 6255.0 ± 14,108.3 pg/mL in males and 277.6 ± 746.3 pg/mL in females, which was found to be a statistically significant difference (p = 0.048) (n = 82). There was also a statistically significant correlation between vitreous IL-6 concentrations, serum C-reactive protein (CRP) value and white blood cell counts (WBCs) (n = 82). In multivariate analysis, vitreous IL-6 levels were significantly correlated with gender and CRP in all cases (p = 0.048 and p < 0.01, respectively) and were also significantly correlated with CRP in non-infectious uveitis (p < 0.01). In infectious uveitis, there were no significant differences between IL-6 level and several variables. Vitreous IL-6 concentrations were higher in males than in females in all cases. In non-infectious uveitis, vitreous IL-6 levels were correlated with serum CRP. These results might suggest that intraocular IL-6 levels depend on gender differences in posterior uveitis, and intraocular IL-6 levels in non-infectious uveitis may reflect systemic inflammations, including increased serum CRP.

20.
Life (Basel) ; 13(3)2023 Mar 13.
Artículo en Inglés | MEDLINE | ID: mdl-36983925

RESUMEN

The purpose of this study was to compare the safety and efficacy of selective retina therapy (SRT) combined with the intravitreal injection of ranibizumab (IVR) in patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO). This trial was a 12-month single-center, randomized, single-masked prospective study. Eligible patients were randomized (1:1) to IVR and SRT (IVR + SRT group), or IVR and sham SRT (IVR + sham group). After the initial IVR, all participants received ME resolution criteria-driven pro re nata treatment. SRT or sham SRT was always applied one day after IVR. The primary outcome measure of this study was the mean change in central macular thickness (CMT) from baseline, and the secondary outcome measures were the mean change in visual acuity from baseline and the number of IVR treatments at a 52-week follow-up. Thirteen patients were in the IVR + SRT group, and 11 were in the IVR + sham group. Compared to the baseline, mean CMT and BCVA improved significantly after 52 weeks in both groups, with no significant difference between the two groups. The mean number of IVR was 2.85 ± 1.52 in the IVR + SRT group and 4.73 ± 2.33 in the IVR + sham group at the 52-week follow-up, with a significant difference between the two groups (p < 0.05). IVR combined with SRT may significantly decrease the number of IVR treatments while maintaining the visual and anatomical improvement effect of IVR monotherapy.

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