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1.
Ophthalmologica ; 246(3-4): 219-226, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37271123

RESUMO

INTRODUCTION: The aim of this study was to determine whether the use of perfluorocarbon liquid (PFCL) affects the rate of retinal re-attachments after an initial attachment by vitrectomy in eyes with rhegmatogenous retinal detachment (RRD). METHODS: This was a retrospective, observational, multicenter study of 3,446 eyes registered in the Japanese vitreoretinal surgery treatment information database. Of these, 2,648 eyes had undergone vitrectomy as the first surgery for RRD. The re-attachment rates after the primary vitrectomy with or without PFCL were evaluated. In addition, the significance of factors affecting the re-detachments was determined by univariate and multivariate analyses. The measured outcomes were the rates of re-attachments after the primary vitrectomy with or without the use of PFCL. RESULTS: A total of 2,362 eyes in the database were analyzed: 325 had and 2,037 did not have PFCL injected into the vitreous cavity during the vitrectomy. The rate of re-attachments was 91.5% in the PFCL group and 93.2% in the non-PFCL group (p = 0.46, χ2 test). Although there were several risk factors associated with the re-detachments in eyes without PFCL (p < 0.05, Welch's t tests, and Fisher's exact tests), they were not associated in eyes with PFCL use. However, multivariate analyses showed that there was no significant association between the use and the non-use of PFCL in the rate of re-detachments (ß = -0.08, p = 0.46). CONCLUSIONS: The use of PFCL during the initial vitrectomy for RRD does not affect the rate of re-attachments.


Assuntos
Fluorocarbonos , Oftalmologia , Descolamento Retiniano , Humanos , Descolamento Retiniano/cirurgia , Retina , Vitrectomia
2.
J Clin Med ; 12(11)2023 May 25.
Artigo em Inglês | MEDLINE | ID: mdl-37297855

RESUMO

PURPOSE: To determine whether atrophy of the retinal pigment epithelium (RPE) in eyes with neovascular age-related macular degeneration (nAMD), which meets the criteria for the suspension of anti-vascular endothelial growth factor (anti-VEGF) treatment, is associated with anti-VEGF treatments. METHODS: Twelve eyes of 12 patients with nAMD who began anti-VEGF treatment and were followed for 1 year after meeting the criteria for the suspension of anti-VEGF were studied. Six eyes of six patients were placed in the continuation group, and six eyes of six patients were placed in the suspension group. The RPE atrophic area at the time of the last anti-VEGF treatment was set as the baseline size and that at 12 months after the baseline (Month 12) was taken as the final size. A comparison of the expansion rate of RPE atrophy between the two groups was made by the square-root transformed differences. RESULTS: The expansion rate of atrophy was 0.55 (0.43, 0.72) mm/year in the continuation group and 0.33 (0.15, 0.41) mm/year in the suspension group. This difference was not significant. (p = 0.29). CONCLUSIONS: Suspension of anti-VEGF treatments in eyes with nAMD does not alter the expansion rate of RPE atrophy.

3.
J Clin Med ; 12(12)2023 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-37373702

RESUMO

Epiretinal membrane (ERM) foveoschisis is a recently proposed clinical entity. The purpose of this study was to compare the clinical characteristics and surgical outcomes of eyes with ERM foveoschisis to those of typical ERM. The medical records of all patients with ERM-related disorders examined between 2011 and 2020 were reviewed. ERM foveoschisis was defined by the clinical criteria proposed by an international panel of experts on ERMs. The background factors, clinical characteristics, and surgical outcomes of ERM foveoschisis were compared to those of typical ERM. Forty eyes with ERM foveoschisis were compared to 333 eyes with typical ERM. The percentage of women was significantly higher in the ERM foveoschisis group (92.5%) than in the typical ERM group (48.9%, p < 0.001). The central macular thickness (CMT) was significantly thinner in the ERM foveoschisis group (340 ± 110 µm) than in the typical ERM groups (476 ± 111 µm, p < 0.01). The degree of improvement in the best-corrected visual acuity (BCVA) three months after the surgery did not differ between the two groups (p = 0.59). These results suggest that the ERM foveoschisis is more likely to occur in women and that the prognosis after surgery is comparable to typical ERM.

4.
Medicina (Kaunas) ; 59(4)2023 Apr 21.
Artigo em Inglês | MEDLINE | ID: mdl-37109767

RESUMO

Background and Objectives: Anti-vascular endothelial growth factor (anti-VEGF) therapy has become the first-line treatment for diabetic macular edema. However, it is still not clear whether anti-VEGF agents act on systemic blood vessels. The aim of this study is to determine whether a direct topical application or intravitreal injection of anti-VEGF will change the intestinal blood vessels of mice. Materials and Methods: C57BL/6 mice were laparotomied under deep anesthesia, and the blood vessels on the surface of the intestines were exposed, examined, and photographed through a dissecting microscope. Vascular changes were evaluated before and at 1, 5, and 15 min after the topical application of 50 µL of the different anti-VEGF agents onto the surface of the intestine (group S) or after the intravitreal injection (group V). The vascular density (VD) was determined for five mice in each group before and after 40 µg/µL of aflibercept (Af), or 25 µg/µL of bevacizumab (Be), or 10 µg/µL of ranibizumab (Ra) were applied. Endothelin-1 (ET1), a potent vasoconstrictor, was used as a positive control, and phosphate-buffered saline (PBS) was used as a control. Results: For group S, no significant changes were observed after PBS (baseline, 1, 5, and 15 min: 46.3, 44.5, 44.8, and 43.2%), Be (46.1, 46.7, 46.7, and 46.3%), Ra (44.7, 45.0, 44.7, and 45.6%), and Af (46.5, 46.2, 45.9, and 46.1%, repeated ANOVA) were applied topically. Significant decreases in the VD were observed after ET1 (46.7, 28.1, 32.1, and 34.0%, p < 0.05) was topically applied. For group V, no significant differences were observed for all anti-VEGF agents. Conclusions: The topical application or intravitreal injections of anti-VEGF agents do not cause a change in the VD of the intestinal vessels, which may be related to its safety.


Assuntos
Retinopatia Diabética , Edema Macular , Animais , Camundongos , Inibidores da Angiogênese/farmacologia , Inibidores da Angiogênese/uso terapêutico , Fatores de Crescimento Endotelial , Edema Macular/etiologia , Fator A de Crescimento do Endotélio Vascular , Camundongos Endogâmicos C57BL , Ranibizumab/uso terapêutico , Bevacizumab/uso terapêutico
5.
Medicine (Baltimore) ; 102(5): e32713, 2023 Feb 03.
Artigo em Inglês | MEDLINE | ID: mdl-36749227

RESUMO

RATIONALE: Multiple evanescent white dot syndrome (MEWDS) is characterized by multiple white dots in the posterior pole of the eye, but its diagnosis can be difficult in cases when the white dots are not visible. We report an atypical case of MEWDS that developed in pathologic myopia. PATIENT CONCERN: A 42-year-old woman presented with floater and reduced and distorted vision in the right eye that she noted 3 days earlier. DIAGNOSIS: The right eye was highly myopic at -17.0 diopters, and her decimal best-corrected visual acuity was reduced to 0.2 (20/100). Fundus examinations revealed no abnormalities other than myopic fundus changes and previous laser photocoagulation spots. However, fundus autofluorescence (FAF) showed multiple hyperfluorescent dots, and optical coherence tomography showed a high reflective lesion on the retinal pigmental epithelium at the fovea. Adjustments of the brightness and contrast of the conventional fundus images revealed white dots in the same location as the hyperfluorescent spots seen in the FAF images. We diagnosed her with MEWDS. INTERVENTIONS: We treated her with systemic administration of 20 mg prednisolone and the dose of prednisolone was reduced by 5 mg every 4 weeks. OUTCOMES: The optical coherence tomography and FAF findings gradually normalized, and 5 months later, her decimal visual acuity was restored to 1.0 (20/20). LESSONS: It was suggested that white dots typical to MEWDS may not be evident in pathologic myopia, and FAF images and the brightness and contrast adjustment of fundus images were useful in the diagnosis of atypical MEWDS.


Assuntos
Miopia , Doenças Retinianas , Síndrome dos Pontos Brancos , Humanos , Feminino , Adulto , Doenças Retinianas/patologia , Angiofluoresceinografia/métodos , Fundo de Olho , Tomografia de Coerência Óptica/métodos
6.
Ocul Immunol Inflamm ; : 1-9, 2023 Jan 26.
Artigo em Inglês | MEDLINE | ID: mdl-36701518

RESUMO

PURPOSE: We investigated potential risk factors for visual prognosis in Japanese patients with exogenous endophthalmitis. METHODS: In this retrospective observational multicenter cohort study, risk factors for legal blindness at 12 weeks after treatment initiation were evaluated based on patient characteristics, initial BCVA, causative events, pathogens, ocular symptoms, duration from symptom onset to initial treatment, and selected treatments. RESULTS: Overall, 23.1% of eyes developed legal blindness. The six risk factors for legal blindness were presence of eye pain, pathogen identification, poor BCVA at the initial visit, longer duration from symptom onset to initial treatment, type of causative event, and type of causative pathogen. Regarding the type of causative pathogen, coagulase-negative staphylococci was associated with a better visual impairment outcome. CONCLUSION: Exogenous endophthalmitis remains a severe ocular infection; however, it can be managed with rapid treatment, as well as other advances in medical knowledge and technology.

7.
Ophthalmol Sci ; 3(1): 100243, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36545261

RESUMO

Purpose: To determine the characteristics and cause of the increase in the amplitude of flicker electroretinography (ERG) after cataract surgery. Design: Prospective, observational clinical study. Participants: Thirty patients who underwent cataract surgery. Methods: Flicker ERGs were recorded with the RETeval system without mydriasis. The central macular thickness (CMT) was measured by OCT and the aqueous flare value (AFV) by laser flare-cell photometry. These examinations were performed before surgery and 1 day, 1 week, 1 month, 2 months, and 3 months after surgery. Linear regression analysis through the origin was used to compare the correlations between the relative changes in flicker ERG amplitudes and the changes in the CMT and AFV at different times after the surgery. Main Outcome Measures: The amplitude of flicker ERGs, CMT, and AFV. Results: The mean amplitude of flicker ERGs increased significantly by 31% at 1 week after surgery (P < 0.001); a significant increase in the amplitudes was not present at 3 months after the surgery. The mean AFV was significantly increased at 1 day after surgery (P < 0.001), and the CMT was significantly increased at 1 to 3 months after surgery (P < 0.001). The changes in flicker ERG amplitudes at 1 week after surgery were significantly associated with the changes in the CMT at 1 to 3 months after surgery (P < 0.05), and they were weakly associated with the changes in AFV at 1 day after surgery (P = 0.05). Conclusions: These results suggest that the increase in the amplitude of flicker ERGs after cataract surgery is a transient phenomenon that has a peak at 1 week after surgery. The increase of flicker ERG amplitude was associated with measures that are frequently used to evaluate postoperative inflammation. Financial Disclosures: Proprietary or commercial disclosure may be found after the references.

9.
Ocul Immunol Inflamm ; 31(7): 1505-1512, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36007241

RESUMO

PURPOSE: We investigated potential predictive factors for visual prognosis in Japanese patients with endogenous endophthalmitis. DESIGN: Retrospective observational multicenter cohort study. METHODS: We examined the characteristics of 77 Japanese patients with endogenous endophthalmitis and performed statistical analyses of these real-world data. The primary endpoint was the identification of factors associated with visual prognosis. We examined differences between patients in the better vision and legal blindness groups at 12 weeks after treatment initiation. RESULTS: The five risk factors for visual impairment at 12 weeks after treatment initiation were presence of pressure injuries, severe clinical symptoms (presence of eye pain and ciliary injection), pathogen identification, and poor best-corrected visual acuity at baseline. Staphylococcus aureus and fungus were associated with a better visual impairment outcome. CONCLUSIONS: Endogenous endophthalmitis remains a severe ocular infection; however, it can be managed with rapid treatments, as well as other advances in medical knowledge and technology.


Assuntos
Endoftalmite , Infecções Oculares Bacterianas , Humanos , Cegueira/prevenção & controle , Estudos de Coortes , População do Leste Asiático , Endoftalmite/microbiologia , Infecções Oculares Bacterianas/microbiologia , Estudos Retrospectivos , Fatores de Risco , Acuidade Visual
10.
Cancers (Basel) ; 16(1)2023 Dec 25.
Artigo em Inglês | MEDLINE | ID: mdl-38201546

RESUMO

Uveal melanoma (UM) is among the most common primary intraocular neoplasms in adults, with limited therapeutic options for advanced/metastatic disease. Since UM is characterized by infrequent p53 mutation coupled with the overexpression of MDM4, a major negative regulator of p53, we aimed to investigate in this study the effects on UM cells of CEP-1347, a novel MDM4 inhibitor with a known safety profile in humans. We also examined the impact of CEP-1347 on the protein kinase C (PKC) pathway, known to play a pivotal role in UM cell growth. High-grade UM cell lines were used to analyze the effects of genetic and pharmacological inhibition of MDM4 and PKC, respectively, as well as those of CEP-1347 treatment, on p53 expression and cell viability. The results showed that, at its clinically relevant concentrations, CEP-1347 reduced not only MDM4 expression but also PKC activity, activated the p53 pathway, and effectively inhibited the growth of UM cells. Importantly, whereas inhibition of either MDM4 expression or PKC activity alone failed to efficiently activate p53 and inhibit cell growth, inhibition of both resulted in effective activation of p53 and inhibition of cell growth. These data suggest that there exists a hitherto unrecognized interaction between MDM4 and PKC to inactivate the p53-dependent growth control in UM cells. CEP-1347, which dually targets MDM4 and PKC, could therefore be a promising therapeutic candidate in the treatment of UM.

11.
Case Rep Ophthalmol ; 13(3): 981-987, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36466066

RESUMO

The development of a full-thickness macular hole (FTMH) is a rare complication of intravitreal injections, and only a small subset of eyes with an FTMH has a spontaneous closure. We report a case of repeated FTMH formations and a spontaneous closure following an intravitreal injection of bevacizumab (IVB) for a central retinal vein occlusion (CRVO). A 39-year-old male patient presented with reduced vision in his right eye and was diagnosed with a CRVO. Two months later, neovascular glaucoma and macular edema (ME) developed and IVB was performed. After 2 weeks, optical coherence tomography revealed an improvement of the ME and the formation of an FTMH with a hyperreflective material in the FTMH. Two months later, there was a recurrence of the ME and a closure of the FTMH, but the hyperreflective material was still present in the retina. Then, another IVB and panretinal photocoagulation were performed. One month later, the ME had improved and the FTMH was closed, but the hyperreflective material was still present in the retina. After another 2 months, the ME recurred and a third IVB was performed. The ME improved without a recurrence of an FTMH. After that, there were no recurrences of the ME, but the FTMH recurred with the progression of a posterior vitreous detachment and development of an epiretinal membrane 1 year after the third IVB. We suggest that an FTMH be included as a complication of intravitreal injections, and it may close spontaneously during the course of the primary disease.

12.
J Clin Med ; 11(21)2022 Oct 29.
Artigo em Inglês | MEDLINE | ID: mdl-36362644

RESUMO

Purpose: To determine whether the response to the initial anti-vascular endothelial growth factor (anti-VEGF) injection to treat diabetic macular edema (DME) is significantly correlated with the response to the third consecutive monthly injection of the same anti-VEGF agent. Methods: Seventy eyes with DME that were treated with an anti-VEGF agent (16 eyes with 1.25-mg bevacizumab, 35 eyes with 0.5-mg ranibizumab, and 19 eyes with 2.0-mg aflibercept) were studied. They were treated with three consecutive monthly injections of one of the three anti-VEGF agents. The best-corrected visual acuity (BCVA) in the logarithm of the minimum angle of resolution (logMAR units) and the central macular thickness (CMT) were measured at the baseline, 1 week after the initial injection, and 1 month after the third consecutive monthly injection. The changes of both values from the baseline 1 week after the initial injection (day 7) and 1 month after the third monthly injection were determined. The significance of the correlations between the BCVA and the CMT was determined. Results: The mean BCVA improved significantly for all three agents (0.38 ± 0.22 logMAR units at the baseline to 0.27 ± 0.25 logMAR units) after the three monthly injections (p < 0.05, repeated ANOVA). For all cases, a moderate but significant correlation was found between the BCVA at day 7 and 1 month after the third injection (r = 0.58, p < 0.01; Spearman's rank correlation). No significant correlation was found for bevacizumab (r = 0.09, p = 0.73), moderate correlation was found for ranibizumab (r = 0.42, p < 0.05), and a strong correlation was found for aflibercept (r = 0.83, p < 0.001) between the BCVA at day 7 and at 1 month after the third injection. The mean CMT improved significantly for all three agents (481.9 ± 96.3 µm at the baseline to 364.1 ± 116.0 µm after the three monthly injections, p < 0.05), and a moderate correlation was found for the three agents between CMT at day 7 to that at one month after the third anti-VEGF injection (r = 0.54, p < 0.01). A moderate correlation was found for all three agents between CMT at day 7 to that at one month after the third anti-VEGF injection (r = 0.68 for bevacizumab, r = 0.41 for ranibizumab and r = 0.53 for aflibercept, p < 0.05). Conclusions: The significant correlations between the results on day 7 to that one month after the third anti-VEGF treatment for DME indicates that the long-term effects of anti-VEGF therapy can be predicted by the short-term response. In addition, the results indicate that there may be differences in the effectiveness between the three anti-VEGF agents.

13.
Medicina (Kaunas) ; 58(10)2022 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-36295479

RESUMO

Background and Objectives: To evaluate the recurrence of diabetic macular edema (DME) after loading an injection of anti-VEGF agents by a pro re nata (PRN) protocol using central retinal thickness (CRT) as a re-injection criterion. Materials and Methods: This is a retrospective, observational single-center study. DME patients with a central retinal thickness (CRT) over 350 µm received a PRN injection of anti-VEGF agents following one to three consecutive monthly loading injections (bevacizumab, ranibizumab, and aflibercept) for 6 months from January 2012 to June 2019. Results: We enrolled a total of 72 eyes for loading injections and the mean CRT improved from 434.04 ± 139.4 µm (before treatment) to 362.9 ± 125.0 µm after the loading injection. One week after injection, 36 eyes (50%) obtained a CRT of ≤350 µm. Fourteen eyes (19.4%) remained with a CRT of ≤350 µm for 6 months without additional injections. A total of 22 eyes (30.6%) had a CRT of >350 µm at 6 months. Fifteen eyes did not receive additional injections because of visual improvement. Conclusions: About 20% of DME patients can be maintained at a CRT of ≤350 µm for 6 months with only a loading injection. However, there is a tendency to delay additional injections for patients with recurrences using PRN protocol.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Retinopatia Diabética/tratamento farmacológico , Ranibizumab/uso terapêutico , Fatores de Crescimento Endotelial , Bevacizumab/efeitos adversos , Injeções Intravítreas , Inibidores da Angiogênese/uso terapêutico , Acuidade Visual , Estudos Retrospectivos , Tomografia de Coerência Óptica , Resultado do Tratamento , Seguimentos , Diabetes Mellitus/tratamento farmacológico
14.
J Clin Med ; 11(16)2022 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-36012896

RESUMO

Diabetic macular edema (DME) induces visual disturbance, and intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs are the accepted first-line treatment. We investigate its impact on glycemic control after starting VEGF treatment for DME on the basis of a questionnaire and changes in hemoglobin A1c (HbA1c). We conducted a retrospective multicenter study analyzing 112 patients with DME who underwent anti-VEGF therapy and their changes in HbA1c over two years. Central retinal thickness and visual acuity significantly improved at three months and throughout the period after initiating therapy (p < 0.0001); a significant change in HbA1c was not found. A total of 59.8% of patients became more active in glycemic control through exercise and diet therapy after initiating therapy, resulting in a significantly lower HbA1c at 6 (p = 0.0047), 12 (p = 0.0003), and 18 (p = 0.0117) months compared to patients who did not. HbA1c was significantly lower after 18 months in patients who stated that anti-VEGF drugs were expensive (p = 0.0354). The initiation of anti-VEGF therapy for DME affects HbA1c levels in relation to more aggressive glycemic control.

15.
Clin Ophthalmol ; 16: 2275-2283, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35872969

RESUMO

Purpose: To compare the therapeutic effects of anti-vascular endothelial growth factor (anti-VEGF) agents in eyes with macular edema associated with branch retinal vein occlusion (BRVO-ME) with glaucoma to those without glaucoma. Patients and Methods: This retrospective study was conducted using the medical records of Mie University Hospital from 2013 to 2017. Patients were recruited if they had received anti-VEGF agents for BRVO-ME treatment and included 30 patients (30 eyes) without glaucoma (G[-] group) and 27 patients (27 eyes) with glaucoma (G[+] group). The central retinal thickness (CRT) and best-corrected visual acuity (BCVA) at 3 months after a single injection of anti-VEGF agents were compared between the two groups. Results: Before treatment, the mean±standard deviation of the CRT was 514.2±117.3 µm for the G[-] group, which was not significantly different from that for the G[+] group (533.4±171.4 µm). The CRT in the G[-] and G[+] groups significantly reduced to 321.1±114.6 µm and 347.8±134.7 µm, respectively, at 1 month after the injection and to 360.4±159.5 µm and 352.4±151.9 µm, respectively, at 3 months after the injection (P<0.01 for each group). The difference in the degree of CRT reduction between the two groups was not significant. Before treatment, the BCVA was 0.42±0.32 logMAR units in the G[-] group and 0.57±0.33 logMAR units in the G[+] group, showing no significant difference. The BCVA in the G[-] and G[+] groups improved significantly to 0.27±0.26 logMAR units and 0.34±0.42 logMAR units, respectively, at 1 month, and to 0.18±0.20 logMAR units and 0.39±0.34 logMAR units, respectively, at 3 months (P<0.01). The BCVA in the G[-] group was significantly better than that in the G[+] group at 3 months (P=0.02). Conclusion: The therapeutic response of anti-VEGF agents for BRVO-ME is affected by the presence of glaucoma.

16.
J Clin Med ; 11(13)2022 Jul 04.
Artigo em Inglês | MEDLINE | ID: mdl-35807188

RESUMO

This study's goal is to determine the accuracy of a linear classifier that predicts the prognosis of patients with macular edema (ME) due to a branch retinal vein occlusion during the maintenance phase of antivascular endothelial growth factor (anti-VEGF) therapy. The classifier was created using the clinical information and optical coherence tomographic (OCT) findings obtained up to the time of the first resolution of ME. In total, 66 eyes of 66 patients received an initial intravitreal injection of anti-VEGF followed by repeated injections with the pro re nata (PRN) regimen for 12 months. The patients were divided into two groups: those with and those without good vision during the PRN phase. The mean AUC of the classifier was 0.93, and the coefficients of the explanatory variables were: best-corrected visual acuity (BCVA) at baseline was 0.66, BCVA at first resolution of ME was 0.51, age was 0.21, the average brightness of the ellipsoid zone (EZ) was -0.12, the intactness of the external limiting membrane (ELM) was -0.14, the average brightness of the ELM was -0.17, the brightness value of EZ was -0.17, the area of the outer segments of the photoreceptors was -0.20, and the intactness of the EZ was -0.24. This algorithm predicted the prognosis over time for individual patients during the PRN phase.

17.
Graefes Arch Clin Exp Ophthalmol ; 260(11): 3489-3498, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-35652946

RESUMO

PURPOSE: To report the safety and effectiveness of intravitreal aflibercept (IVT-AFL) for diabetic macular edema (DME) in the real-world clinical practice setting in Japan. METHODS: In this prospective, multicenter, observational, post-marketing surveillance, patients with DME newly receiving IVT-AFL were enrolled. During a 24-month follow-up, the primary outcome was the occurrence of safety events. Other pre-specified endpoints were effectiveness indicators, such as best-corrected visual acuity (BCVA), central retinal thickness, and injection frequency. RESULTS: In total, 646 patients administered at least one IVT-AFL injection were included in the safety analysis. During the follow-up period, adverse events occurred in 42 patients (6.50%), whereas adverse drug reactions occurred in 12 (1.86%). In the 12 patients who had adverse drug reactions, seven events occurred in seven patients within the first month of the most recent injection. In addition, 622 patients were included in the effectiveness analysis set. The number of injections over 24 months was 3.6 ± 3.0 (mean ± standard deviation [SD]). BCVA (logarithm of the minimum angle of resolution) was 0.437 ± 0.362 (mean ± SD) (n = 622) at baseline and 0.321 ± 0.348 (n = 177) after 24 months of treatment with IVT-AFL. Central retinal thickness was 440.8 ± 134.2 µm (mean ± SD) (n = 444) at baseline and 355.5 ± 126.4 µm (n = 140) at 24 months. CONCLUSION: Routine administration of IVT-AFL for DME was not associated with new safety concerns, and BCVA outcomes were maintained over 24 months in the real-world setting. Nonetheless, patients in this real-world setting received fewer injections than those in clinical trials, suggesting that a margin for improvement exists in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02425501.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Edema Macular , Humanos , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Retinopatia Diabética/complicações , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Estudos Prospectivos , Japão/epidemiologia , Injeções Intravítreas , Acuidade Visual , Receptores de Fatores de Crescimento do Endotélio Vascular , Proteínas Recombinantes de Fusão/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/complicações , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/tratamento farmacológico , Resultado do Tratamento , Inibidores da Angiogênese
19.
J Diabetes Investig ; 13(8): 1339-1346, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35389565

RESUMO

AIMS/INTRODUCTION: In older patients, the management of diabetic macular edema (DME) can be complicated by comorbidities, geriatric syndrome, and socioeconomic status. This study aims to evaluate the effects of aging on the management of DME. MATERIALS AND METHODS: This is a real-world clinical study including 1,552 patients with treatment-naïve center-involved DME. The patients were categorized into 4 categories by age at baseline (C1, <55; C2, 55-64; C3, 65-74; and C4, ≥75 years). The outcomes were the change in logarithm of the minimum angle of resolution best-corrected visual acuity (logMAR BCVA) and central retinal thickness (CRT), and the number of treatments from baseline to 2 years. RESULTS: From baseline to 2 years, the mean changes in logMAR BCVA from baseline to 2 years were -0.01 in C1, -0.06 in C2, -0.07 in C3, and 0.01 in C4 (P = 0.016), and the mean changes in CRT were -136.2 µm in C1, -108.8 µm in C2, -100.6 µm in C3, and -89.5 µm in C4 (P = 0.008). Treatments applied in the 2 year period exhibited decreasing trends with increasing age category on the number of intravitreal injections of anti-VEGF agents (P = 0.06), selecting local corticosteroid injection (P = 0.031), vitrectomy (P < 0.001), and laser photocoagulation outside the great vascular arcade (P < 0.001). CONCLUSIONS: Compared with younger patients with DME, patients with DME aged ≥75 years showed less frequent treatment, a lower BCVA gain, and a smaller CRT decrease. The management and visual outcome in older patients with DME would be unsatisfactory in real-world clinical practice.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Idoso , Envelhecimento , Retinopatia Diabética/complicações , Retinopatia Diabética/epidemiologia , Retinopatia Diabética/terapia , Humanos , Edema Macular/tratamento farmacológico , Edema Macular/terapia , Estudos Retrospectivos , Resultado do Tratamento , Acuidade Visual
20.
Graefes Arch Clin Exp Ophthalmol ; 260(6): 1867-1876, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35094126

RESUMO

PURPOSE: To investigate the outcomes of a suspension of anti-vascular endothelial growth factor (anti-VEGF) treatments in the eyes with neovascular age-related macular degeneration (nAMD). METHODS: This was a retrospective study that examined eyes having no exudation for 48 weeks while undergoing intravitreal anti-VEGF injections every 12 to 16 weeks. The rate and time of recurrences, best-corrected visual acuity (BCVA), central subfield thickness (CST), number of visits, and reactivity to anti-VEGF were determined after the suspension of the anti-VEGF treatments. RESULTS: In 34 eyes of 34 patients, 17 eyes (50.0%) had a recurrence during the 24-month follow-up period. The median time of a recurrence was 10 months. The BCVA was maintained for 24 months after the suspension regardless of the development of any recurrences. In 41.7% of the eyes that resumed treatment, the duration of exudation suppression by the anti-VEGF therapy was shorter than 12 weeks during the 12 months after restarting the anti-VEGF treatments. There was a significant increase in the number of visits during the first year after beginning the suspension versus during the 1 year before the suspension (non-recurrence group; P = 0.007, recurrence group; P = 0.001). CONCLUSION: Although one-half of the eyes had a recurrence within 24 months after a suspension of anti-VEGF treatment, the BCVA was maintained after a resumption of the anti-VEGF treatments. However, the number of hospital visits increases regardless of the recurrences and the lesion stability is altered by the anti-VEGF suspension. Clinicians should explain both the advantages and disadvantages of anti-VEGF suspension to nAMD patients.


Assuntos
Degeneração Macular , Degeneração Macular Exsudativa , Inibidores da Angiogênese , Humanos , Injeções Intravítreas , Degeneração Macular/tratamento farmacológico , Ranibizumab , Recidiva , Estudos Retrospectivos , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular , Fatores de Crescimento do Endotélio Vascular , Acuidade Visual , Degeneração Macular Exsudativa/diagnóstico , Degeneração Macular Exsudativa/tratamento farmacológico
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