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2.
Int Ophthalmol ; 44(1): 166, 2024 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-38557801

RESUMEN

PURPOSE: To evaluate the safety and effectiveness of various treatment modalities in patients with diabetic retinopathy (DR) who underwent cataract surgery. METHODS: A comprehensive search for randomized controlled trials (RCTs) was conducted using the PubMed, Embase, Cochrane Library, and CNKI databases up to December 22, 2021. The safety and efficacy of treatment modalities were assessed using the risk ratio (RR) to compare the progression of DR and the mean difference to evaluate the best corrected visual acuity (BCVA) and macular thickness (MT). RESULTS: The meta-analysis of the RCTs revealed that anti-VEGF (anti-vascular endothelial growth factor) drugs significantly reduced the progression of DR [RR: 0.37 (95%CI 0.19, 0.70), P = 0.002] and improved BCVA [mean difference = - 0.06 (- 0.12, - 0.01), P = 0.03] in patients with pre-existing DR who underwent cataract surgery. Steroid drugs also showed a significant reduction in macular thickness [mean difference = - 55.63 (- 90.73, - 20.53), I2 = 56%, P = 0.002] in DR patients two weeks after cataract surgery compared to the control group. The safety profiles of different management options did not differ significantly. CONCLUSION: The present meta-analysis suggests that anti-VEGF drugs can effectively slow down the progression of diabetic retinopathy, improve BCVA, and reduce MT in DR patients who underwent cataract surgery. Steroid drugs also show promise in reducing MT. However, further studies with larger sample sizes are required to compare the efficacy and safety of different management options in a multi-center clinical setting.


Asunto(s)
Catarata , Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Humanos , Retinopatía Diabética/complicaciones , Retinopatía Diabética/tratamiento farmacológico , Ranibizumab/uso terapéutico , Bevacizumab/uso terapéutico , Factor A de Crecimiento Endotelial Vascular , Edema Macular/tratamiento farmacológico , Esteroides/uso terapéutico
3.
Sci Rep ; 14(1): 9600, 2024 04 26.
Artículo en Inglés | MEDLINE | ID: mdl-38671028

RESUMEN

Aim of this study was to evaluate the efficacy of switching treatment to faricimab in neovascular age-related macular degeneration (nAMD) from other anti-VEGF agents. Fifty-eight eyes of fifty-one patients with nAMD and a full upload series of four faricimab injections were included. Demographic data, multimodal imaging and treatment parameters were recorded. The primary outcome measures were changes in central subfield thickness (CST) and subfoveal choroidal thickness (SFCT). A subgroup analysis was performed for eyes with prior ranibizumab (R) or aflibercept (A) treatment. Mean injection intervals before and after switching were comparable (33.8 ± 11.2 vs. 29.3 ± 2.6 days; p = 0.08). Mean CST of 361.4 ± 108.1 µm prior to switching decreased significantly to 318.3 ± 97.7 µm (p < 0.01) after the third faricimab injection, regardless of prior anti-VEGF treatment (p < 0.01). Although SFCT slightly improved for the whole cohort from 165.8 ± 76.8 µm to 161.0 ± 82,8 µm (p = 0.029), subgroup analysis did not confirm this positive effect (subgroup R: p = 0.604; subgroup A: p = 0.306). In patients with a suboptimal response to aflibercept or ranibizumab in nAMD, farcimab can improve CST and slightly improve or maintain SFCT. Further prospective randomized trials are warranted.


Asunto(s)
Inhibidores de la Angiogénesis , Coroides , Ranibizumab , Receptores de Factores de Crecimiento Endotelial Vascular , Proteínas Recombinantes de Fusión , Humanos , Masculino , Femenino , Anciano , Ranibizumab/administración & dosificación , Ranibizumab/uso terapéutico , Proteínas Recombinantes de Fusión/administración & dosificación , Proteínas Recombinantes de Fusión/uso terapéutico , Coroides/efectos de los fármacos , Coroides/diagnóstico por imagen , Coroides/patología , Anciano de 80 o más Años , Resultado del Tratamiento , Inhibidores de la Angiogénesis/uso terapéutico , Inhibidores de la Angiogénesis/administración & dosificación , Receptores de Factores de Crecimiento Endotelial Vascular/uso terapéutico , Receptores de Factores de Crecimiento Endotelial Vascular/administración & dosificación , Retina/patología , Retina/efectos de los fármacos , Retina/diagnóstico por imagen , Inyecciones Intravítreas , Degeneración Macular/tratamiento farmacológico , Degeneración Macular/patología , Tomografía de Coherencia Óptica , Agudeza Visual/efectos de los fármacos , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Sustitución de Medicamentos
4.
Medicine (Baltimore) ; 103(16): e37839, 2024 Apr 19.
Artículo en Inglés | MEDLINE | ID: mdl-38640269

RESUMEN

This study aimed to elucidate 1-year outcomes following switching to the aflibercept (3 mg) therapy for treatment-resistant wet age-related macular degeneration (wAMD). In this prospective, open-label, non-controlled clinical trial, 18 patients with wAMD who had multiple recurrences or persistent exudation despite intravitreal injections of anti-vascular endothelial growth factor agents (except aflibercept) received a 3-mg intravitreal aflibercept injection every 4 weeks. Each patient received 3 to 8 injections. The central retinal thickness and fibrovascular pigment epithelial detachment height decreased significantly at 1 month after initiation of the aflibercept injection, and the values were 146 and 163.2 µm, respectively, at the final visit. The morphological improvement was sustained. The intraretinal and subretinal fluid was completely absorbed at the end of the follow-up. The logMAR vision increased from baseline 0.68 to 0.59 (P < .05). No ocular or systemic adverse events occurred. The intravitreal injection of 3-mg aflibercept seems to be feasible in the treatment of wAMD unresponsive to other anti-vascular endothelial growth factor agents.


Asunto(s)
Factores de Crecimiento Endotelial , Degeneración Macular Húmeda , Humanos , Inhibidores de la Angiogénesis/uso terapéutico , Factores de Crecimiento Endotelial/uso terapéutico , Inyecciones Intravítreas , Estudios Prospectivos , Ranibizumab/uso terapéutico , Receptores de Factores de Crecimiento Endotelial Vascular/uso terapéutico , Proteínas Recombinantes de Fusión/uso terapéutico , Retina , Tomografía de Coherencia Óptica , Resultado del Tratamiento , Degeneración Macular Húmeda/tratamiento farmacológico
5.
Indian J Ophthalmol ; 72(5): 722-727, 2024 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-38648434

RESUMEN

PURPOSE: This study aims to establish DROL (disruption of retinal outer layers), PROS (photoreceptor outer segment length), SND (subfoveal neuroretinal detachment), and hyperreflective walls of foveal cystoid spaces (HRW) as optical coherence tomography (OCT) biomarkers and predictors of central macular thickness (CMT) and visual acuity in diabetic macular edema (DME) treated with intravitreal ranibizumab (IVR). METHODS: In this prospective, interventional study performed at a tertiary care center over a span of 1 year from December 2021 to December 2022, 50 eyes of 46 patients of DME were included. Visual acuity and spectral domain OCT imaging were performed at baseline. Using inbuilt calipers on SD-OCT, the horizontal extent of DROL and the vertical extent of PROS were measured manually. SND and HRW were assessed qualitatively. IVR was administered and patients were followed up at 4, 8, and 12 weeks. RESULTS: The eyes without DROL had statistically significant (P < 0.05) lesser CMT and better BCVA (best-corrected visual acuity) (P < 0.05) after pro re nata injection of IVR. There was a positive correlation between the extent of baseline DROL with final CMT (P < 0.05) and final logMAR BCVA (P > 0.05), whereas negative correlation with the extent of baseline PROS with final CMT (P < 0.05) and final logMAR BCVA (P > 0.05). The presence of HRW and SND predicted non-resolution of CMT and worse visual acuity after treatment with IVR in DME. CONCLUSION: DROL, PROS, SND, and hyperreflective walls of foveal cystoid spaces may be utilized as qualitative as well as quantitative biomarkers to predict the post-treatment CMT and visual acuity in DME.


Asunto(s)
Inhibidores de la Angiogénesis , Retinopatía Diabética , Fóvea Central , Inyecciones Intravítreas , Edema Macular , Ranibizumab , Tomografía de Coherencia Óptica , Agudeza Visual , Humanos , Tomografía de Coherencia Óptica/métodos , Ranibizumab/administración & dosificación , Ranibizumab/uso terapéutico , Edema Macular/tratamiento farmacológico , Edema Macular/diagnóstico , Edema Macular/etiología , Edema Macular/fisiopatología , Agudeza Visual/fisiología , Masculino , Retinopatía Diabética/tratamiento farmacológico , Retinopatía Diabética/diagnóstico , Retinopatía Diabética/fisiopatología , Retinopatía Diabética/complicaciones , Estudios Prospectivos , Inhibidores de la Angiogénesis/administración & dosificación , Inhibidores de la Angiogénesis/uso terapéutico , Femenino , Persona de Mediana Edad , Fóvea Central/patología , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Estudios de Seguimiento , Mácula Lútea/patología , Biomarcadores , Anciano , Segmento Externo de las Células Fotorreceptoras Retinianas/patología
6.
Keio J Med ; 73(1): 12, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38522916

RESUMEN

Angiogenesis, the development of new blood vessels, is a fundamental physiological process. In addition, angiogenesis plays a key role in the pathogenesis of several disorders, including cancer and eye disorders such as diabetic retinopathy and age-related macular degeneration (AMD). However, identifying the regulators of angiogenesis proved challenging. Numerous factors that stimulated angiogenesis in various bioassays were identified, but their pathophysiological role remained unclear. In 1989, we reported the isolation and cloning of vascular endothelial growth factor (VEGF, VEGF-A) as an endothelial cell-specific mitogen and angiogenic factor. The tyrosine kinases Flt-1 (VEGFR-1) and KDR (VEGFR-2) were subsequently identified as VEGF receptors. Loss of a single vegfa allele results in defective vascularization and embryonic lethality in mice, emphasizing the essential role of VEGF in the development of blood vessels. Subsequently, we reported that anti-VEGF monoclonal antibodies block growth and neovascularization in tumor models. These findings paved the way for the clinical development of a humanized anti-VEGF antibody and other VEGF inhibitors for cancer therapy. To date, several VEGF inhibitors represent standard of care for colorectal cancer and other difficult to treat malignancies. VEGF is also implicated in intraocular neovascularization associated with retinal disorders as well as neovascular AMD. Our group developed a humanized anti-VEGF-A antibody fragment (ranibizumab) for the treatment of wet AMD. Ranibizumab not only maintained but also improved visual acuity and has been approved worldwide for the treatment of wet AMD and other neovascular disorders. Other VEGF inhibitors, including bevacizumab and aflibercept, have also resulted in significant clinical benefits. Today anti-VEGF drugs represent the most effective therapy for intraocular neovascularization. Current research addresses the need to reduce the frequency of intravitreal injections as well the identification of additional pro-angiogenic pathways that could result in improving therapeutic outcomes.


Asunto(s)
Neoplasias , Degeneración Macular Húmeda , Animales , Ratones , Ranibizumab/uso terapéutico , Inhibidores de la Angiogénesis/farmacología , Inhibidores de la Angiogénesis/uso terapéutico , Factor A de Crecimiento Endotelial Vascular/genética , Anticuerpos Monoclonales Humanizados/uso terapéutico , Angiogénesis , Degeneración Macular Húmeda/tratamiento farmacológico , Agudeza Visual , Neovascularización Patológica/tratamiento farmacológico , Neovascularización Patológica/genética , Neovascularización Patológica/metabolismo
7.
Ocul Surf ; 32: 222-226, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38490478

RESUMEN

PURPOSE: To investigate cytokine levels in the tear fluid of patients receiving serial intravitreal injections (IVI) with anti-vascular endothelial growth factor (anti-VEGF) for neovascular age-related macular degeneration (nAMD). METHODS: Concentrations of six cytokines (IFN-γ, IL-1ß, IL-6, IL-8, TNF and VEGF) in tears of patients receiving anti-VEGF in one eye were assayed using multiplex cytometric bead array. The fellow untreated eye served as control. Tear sampling was performed on a single occasion at a minimum of four weeks after IVI. Patients underwent a pre-IVI antisepsis protocol with povidone-iodine. RESULTS: Tear fluid from thirty patients with a mean age of 78.8 years (range 58-90) was assayed. Subjects received a median of 43.5 (range 22-106) IVI in one eye. The median level of IFN-γ was 0.33 (interquartile range (IQR) 0.22-0.52) pg/mg of total protein in injected eyes versus 0.41 (IQR 0.21-1.05) pg/mg in fellow eyes (p = 0.017). For TNF, a median level of 0.12 (IQR 0.08-0.18) pg/mg of total protein was found in injected eyes versus 0.14 (IQR 0.07-0.33) pg/mg of total protein in fellow eyes (p = 0.019). There were no differences between injected and fellow eyes regarding the levels of IL-1ß, IL-6, IL-8 and VEGF. CONCLUSION: Tear fluid in eyes receiving serial IVI with anti-VEGF and preoperative povidone-iodine antisepsis constitutes lower levels of the pro-inflammatory cytokines IFN-γ and TNF compared to fellow eyes. This provides biochemical support of previous findings of reduced signs of inflammation and healthier tear film parameters in patients treated with serial IVI.


Asunto(s)
Inhibidores de la Angiogénesis , Citocinas , Inyecciones Intravítreas , Lágrimas , Humanos , Lágrimas/metabolismo , Anciano , Citocinas/metabolismo , Masculino , Femenino , Persona de Mediana Edad , Anciano de 80 o más Años , Inhibidores de la Angiogénesis/administración & dosificación , Inhibidores de la Angiogénesis/uso terapéutico , Factor A de Crecimiento Endotelial Vascular/metabolismo , Ranibizumab/administración & dosificación , Ranibizumab/uso terapéutico , Degeneración Macular Húmeda/tratamiento farmacológico , Degeneración Macular Húmeda/metabolismo , Estudios Prospectivos
11.
BMC Ophthalmol ; 24(1): 123, 2024 Mar 18.
Artículo en Inglés | MEDLINE | ID: mdl-38494487

RESUMEN

INTRODUCTION: In neovascular age-related macular degeneration (nAMD) trials, anti-VEGF injection frequency decreases after the first year, while outcomes remain primarily related to the number of injections. To the best of our knowledge, there are no reports of maintaining the best corrected visual acuity (BCVA) for more than 7 years in extension studies. OBJECTIVE: To report a 12-year follow-up of a real-world case of nAMD where BCVA was preserved from declining. CASE DESCRIPTION: A 67-year-old Caucasian female presented to our department in June 2010 due to decreased vision in her left eye (LE) within the preceding months. Examination showed a BCVA of 85 letters (L) in the right eye (RE) and 35 L in the LE. Fundus examination showed drusen in the macula of both eyes. Macular edema, loss of the macular lutein pigment, macular hypo/hyperpigmentation were observed in the LE. A diagnosis of Type 2 choroidal neovascular membrane (CNV) in the LE was established and within two months a Type 1 CNV developed in the RE. She undergone 9 injections of bevacizumab (six) and ranibizumab (three) within the first year of treatment in the LE and seven injections of ranibizumab within the first year in the RE. RESULTS: The LE had a mean of 5.2 injections per year, and the RE had a mean of 7.5 injections per year, from 2010 to 2022. RE's BCVA dropped by 8L (85L to 77L) and central retinal thickness (CRT) increased by 16 µm (276 µm to 292 µm) while LE's BCVA increased by 28L (35L to 63L) and CRT decreased by 369 µm (680 µm to 311 µm), at the twelfth year. CONCLUSIONS: Although the final visual outcome depends on baseline BCVA and lesion type or size, the number of injections is paramount in preserving BCVA and achieving favorable functional outcomes in nAMD, even after 12 years of treatment.


Asunto(s)
Neovascularización Coroidal , Edema Macular , Humanos , Femenino , Anciano , Ranibizumab/uso terapéutico , Inhibidores de la Angiogénesis/uso terapéutico , Factor A de Crecimiento Endotelial Vascular , Inyecciones Intravítreas , Edema Macular/tratamiento farmacológico , Neovascularización Coroidal/diagnóstico , Neovascularización Coroidal/tratamiento farmacológico , Agudeza Visual
12.
Zhonghua Yan Ke Za Zhi ; 60(3): 215-219, 2024 Mar 11.
Artículo en Chino | MEDLINE | ID: mdl-38462368

RESUMEN

Neovascular age-related macular degeneration (nAMD) is a leading cause of blindness in the elderly, and anti-vascular endothelial growth factor (VEGF) therapy is currently the primary treatment approach. However, the real-world effectiveness of nAMD treatment is not always satisfactory and faces various challenges. Frequent administration and follow-up burdens can lead to decreased patient compliance during long-term treatment, resulting in suboptimal outcomes. Some lesions exhibit poor or no response to anti-VEGF treatment, leading to difficulties in maintaining or even declining visual acuity. Factors such as lesion fibrosis and tissue atrophy can contribute to visual deterioration. Therefore, standardizing and individualizing treatment plans, along with enhancing comprehensive monitoring and management throughout the disease course, are crucial improvement measures. The evidence-based guidelines for diagnosis and treatment of age-related macular degeneration in China, released in 2023, provide guidance for standardized clinical diagnosis and treatment. Meanwhile, research and development of new drugs and administration methods are anticipated for the future.


Asunto(s)
Degeneración Macular , Degeneración Macular Húmeda , Humanos , Anciano , Ranibizumab/uso terapéutico , Inhibidores de la Angiogénesis/uso terapéutico , Factor A de Crecimiento Endotelial Vascular , Degeneración Macular/terapia , Agudeza Visual , Inyecciones Intravítreas , Degeneración Macular Húmeda/tratamiento farmacológico , Resultado del Tratamiento
13.
Curr Opin Ophthalmol ; 35(3): 197-204, 2024 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-38345051

RESUMEN

PURPOSE OF REVIEW: The increasing prevalence of diabetic macular edema (DME) necessitates an updated review of treatment modalities. While the shift from laser to anti-vascular endothelial growth factor (anti-VEGF) therapy has transformed patient outcomes, benefits of these agents are not fully realized in real-world implementation relative to the setting of controlled clinical trials. This review outlines the evolution of intravitreal anti-VEGF treatment extension protocols for DME that reflect efforts to address treatment adherence challenges while optimizing visual outcomes. RECENT FINDINGS: Recent studies highlight the efficacy of extended-interval dosing with anti-VEGF agents in managing DME. Trials such as RISE/RIDE, VISTA/VIVID, and LUCIDATE have established the foundation of these regimens by demonstrating sustained visual gains with continuous treatment. However, newer trials including PROTOCOL T, KESTREL/KITE, YOSEMITE/RHINE, and PHOTON have furthered this concept, revealing that less frequent dosing of various anti-VEGF agents can maintain similar visual acuity and anatomical outcomes to traditional monthly injections. SUMMARY: The reviewed findings suggest a paradigm shift in DME treatment toward less frequent anti-VEGF injections. This has significant implications for clinical practice, potentially leading to greater adherence to treatment regimens and sustained visual function in patients, while minimizing treatment burden and healthcare costs. Further investigation into the long-term effects of extended dosing intervals is required.


Asunto(s)
Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Humanos , Edema Macular/tratamiento farmacológico , Retinopatía Diabética/tratamiento farmacológico , Factores de Crecimiento Endotelial/uso terapéutico , Inhibidores de la Angiogénesis/efectos adversos , Factor A de Crecimiento Endotelial Vascular , Receptores de Factores de Crecimiento Endotelial Vascular/uso terapéutico , Retratamiento , Inyecciones Intravítreas , Ranibizumab/uso terapéutico , Diabetes Mellitus/tratamiento farmacológico
14.
Ophthalmologie ; 121(3): 196-206, 2024 Mar.
Artículo en Alemán | MEDLINE | ID: mdl-38315190

RESUMEN

INTRODUCTION: Digitalization in medicine, especially the electronic documentation of patient data, is revolutionizing healthcare systems worldwide. The evaluation of real-world data collected under everyday conditions presents opportunities but also challenges. Electronic medical registries provide a means to compile extensive patient data for scientific inquiries. Oregis is the first nationwide digital registry for health services research established by the German Ophthalmological Society (DOG). Intravitreal operative medicinal injections (IVOM) are among the most frequently performed procedures in ophthalmology. Data on injection numbers and injection frequencies with anti-vascular endothelial growth factor (VEGF) are already available from other countries, whereas data at a national level are not yet available in Germany due to the lack of a nationwide register. It is known that the treatment success of anti-VEGF IVOMs depends largely on the adherence to treatment and thus on the number of injections. There are also differences in cost. In the context of this study, real-world data on the frequency and distribution of intravitreal injections in German centers from 2015 to 2021 were compiled for the first time since the introduction of oregis. The aim of this study is to collect data on the use of anti-VEGF IVOMs in Germany from oregis for the first time and to show the development of injection numbers and anti-VEGF drugs used. At the same time, the possibilities of data retrieval from oregis are demonstrated using a concrete example from daily ophthalmological practice. MATERIAL AND METHODS: An automated query of records was performed for all patients who received IVOM at oregis-affiliated healthcare facilities between 2015 and 2021. The number of treated patients and the use of anti-VEGF medications, including aflibercept, bevacizumab, brolucizumab, and ranibizumab, were determined. The data were collected in a pseudonymized and anonymized manner. RESULTS: At the time of data collection, 9 German ophthalmological healthcare facilities were affiliated with oregis. In total, 309,152 patients were registered during the observation period, with 8474 receiving IVOMs. Over the observation period, the number of participating centers, patients, and intravitreal injections increased. The proportional share of anti-VEGF agents among the total number of injections varied during the observation period. DISCUSSION: Real-world data captured in oregis offer significant potential for enhancing healthcare provision. Oregis enables the depiction of ophthalmological care conditions in Germany and contributes to research and quality assurance. The ability to query the presented data exemplifies the multitude of inquiries through which oregis can contribute to the representation of ophthalmological care in Germany.


Asunto(s)
Inhibidores de la Angiogénesis , Factor A de Crecimiento Endotelial Vascular , Humanos , Inyecciones Intravítreas , Ranibizumab/uso terapéutico , Bevacizumab/uso terapéutico
15.
Medicine (Baltimore) ; 103(5): e34583, 2024 Feb 02.
Artículo en Inglés | MEDLINE | ID: mdl-38306515

RESUMEN

BACKGROUND: To systematically evaluate the efficacy and safety of subthreshold micropulse laser (SML) combined with anti-vascular endothelial growth factor (VEGF) drugs for the treatment of diabetic macular edema (DME). METHODS: The randomized controlled trials on SML combined with anti-VEGF drugs for DME were retrieved from China National Knowledge Infrastructure, Wan Fang Data, VIP Data, Sino Med (China Biomedical Literature Database), PubMed, Web of Science, The Cochrane Library, and Embase by computer from inception to April 19, 2022. The observation group was treated with SML combined with anti-VEGF drugs, while the control group was treated with anti-VEGF agents alone or SML. And the references of the included literature were manually searched. The Meta-analysis was performed using Revman 5.4 and STATA SE 15. RESULTS: This study finally included 15 randomized controlled trials involving 891 eyes for Meta-analysis. The results showed that there was no statistically significant difference between the 2 groups in best-corrected visual acuity at 1, 3, 6, 9, and 12 months after treatment. There was no statistical difference between the 2 groups in central macular thickness (CMT) at 1, 3, and 6 months after treatment (P > .05). CMT in the observation group was lower than that in the control group at 9 and 12 months (P < .05). There was no statistical difference between the 2 groups in total macular volume at 3, 6, 9, and 12 months in CMT (P > .05). The number of anti-VEGF drugs injections in the observation was lower than that in the control group (P < .05). The occurrence of complications between the 2 groups was not statistically significant difference (P > .05). CONCLUSION: SML in combination with anti-VEGF drugs in patients with DME are comparable in reducing the number of anti-VEGF drugs injections and CMT, thereby reducing the financial burden on patients. It does not differ in best-corrected visual acuity and total macular volume.


Asunto(s)
Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Humanos , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Edema Macular/cirugía , Retinopatía Diabética/tratamiento farmacológico , Retinopatía Diabética/cirugía , Ranibizumab/uso terapéutico , Factor A de Crecimiento Endotelial Vascular/uso terapéutico , Factores de Crecimiento Endotelial Vascular/uso terapéutico , Resultado del Tratamiento , Rayos Láser , Diabetes Mellitus/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto
16.
BMC Ophthalmol ; 24(1): 73, 2024 Feb 16.
Artículo en Inglés | MEDLINE | ID: mdl-38365648

RESUMEN

BACKGROUND: The most feared complication of intravitreal injections is the development of endophthalmitis, which could lead to irreversible visual loss. The aim of this study was to characterize the clinical profiles, causative pathogens, and clinical outcome of patients post-endophthalmitis. METHODS: Retrospective, single center case series study. Clinical records, causative pathogens and management of all cases of endophthalmitis post intravitreal anti-vascular endothelial growth factor (VEGF) injections recorded between January 1st, 2006 and May 30th, 2022; were retrieved. The visual and anatomic changes prior to the episode of endophthalmitis and up to 2 years post-treatment were compared. RESULTS: Eleven post-injection endophthalmitis eyes of 10 patients (n = 3 females; 30%) were recruited at mean age of 64.5 ± 20.4 years. The median last recorded BCVA, up to 3 months prior to the episode of endophthalmitis was 60 (Interquartile range (IQR) 55-75) ETDRS letters. Then, it dropped to 30 (IQR 0-57.5), 35 (IQR 0-52.5) and 35 (IQR 0-57.5) ETDRS letters at presentation, 6- and 12-months follow-up; respectively (p = 0.027, p = 0.017 and p = 0.012). However, at 24 months, the median BCVA returned to similar baseline values prior to the episode of endophthalmitis; BCVA 50 (IQR 0-60) ETDRS letters, p = 0.062. Interestingly, two eyes with neovascular age-related macular degeneration (NVAMD), 1 with myopic choroidal neovascularization (CNV) and 1 with retinal vein occlusion (RVO), experienced disease quiescence and did not require additional anti-VEGF injections up to 2 years of follow-up. CONCLUSION: This study demonstrates long-term recovery of vision loss due to endophthalmitis post anti-VEGF injections, regained up to 2 years later. It also indicates that disease quiescence post endophthalmitis may not only occur in eyes treated for NVAMD, but also with myopic CNV and RVO.


Asunto(s)
Neovascularización Coroidal , Endoftalmitis , Oclusión de la Vena Retiniana , Femenino , Humanos , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Ranibizumab/uso terapéutico , Inhibidores de la Angiogénesis , Bevacizumab/uso terapéutico , Factor A de Crecimiento Endotelial Vascular , Estudios Retrospectivos , Oclusión de la Vena Retiniana/tratamiento farmacológico , Neovascularización Coroidal/tratamiento farmacológico , Inyecciones Intravítreas , Endoftalmitis/etiología , Endoftalmitis/complicaciones
17.
Drug Des Devel Ther ; 18: 365-374, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38347957

RESUMEN

Ranibizumab, is a humanized, monoclonal antibody fragment that binds and inactivates vascular endothelial growth factor-A (VEGF-A) and VEGF-B. One of the main indications for an intravitreal treatment with ranibizumab is age-related macular degeneration (AMD), which is a retinal disease with a high worldwide socioeconomic impact. Biosimilars constitute biological products that demonstrate similar pharmacodynamic and pharmacokinetic characteristics with a reference product, as well as comparable clinical efficacy, safety and immunogenicity. Since the approval of the first biosimilar Razumab, there has been a variety of new biosimilars available on the market. They offer the advantage of the same good clinical and safety results at a better price. All Ranibizumab biosimilars that have gained approval were tested in double masked Phase 3 clinical studies. The use of Ranibizumab biosimilars in neovascular AMD is well reported in the bibliography. Nevertheless, over the last few years, there is a tendency of using biosimilars in other retinal diseases like retinopathy of prematurity (ROP), diabetic macular edema (DME) or polypoidal choroidal vasculopathy (PCV). In conclusion, ranibizumab biosimilars offer a promising avenue for the management of retinal diseases, especially in countries with lower socioeconomic status, where there is lack of availability of innovator ranibizumab. However, further research is required to fully explore their efficacy, safety, and long-term outcomes in a plethora of retinal diseases.


Asunto(s)
Biosimilares Farmacéuticos , Retinopatía Diabética , Edema Macular , Degeneración Macular Húmeda , Recién Nacido , Humanos , Ranibizumab/uso terapéutico , Biosimilares Farmacéuticos/efectos adversos , Factor A de Crecimiento Endotelial Vascular , Inhibidores de la Angiogénesis/uso terapéutico , Retinopatía Diabética/tratamiento farmacológico , Análisis Costo-Beneficio , Edema Macular/tratamiento farmacológico , Agudeza Visual , Degeneración Macular Húmeda/tratamiento farmacológico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Inyecciones Intravítreas , Ensayos Clínicos Controlados Aleatorios como Asunto
18.
Eye (Lond) ; 38(7): 1342-1348, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38279038

RESUMEN

BACKGROUND: Some patients with neovascular age-related macular degeneration (nAMD) respond insufficiently to anti-VEGF treatment despite maximal monthly intravitreal injections. Their short-term response between injections was investigated for extent and visual prognosis. SUBJECTS/METHODS: Monocentric retrospective observational study. 45 eyes from 41 patients with refractory nAMD (who previously received at least 12 months of anti-VEGF treatment), evaluated by optical coherence tomography (OCT) in between monthly anti-VEGF injections. The fluid profile on OCT was evaluated before, 1 week after, and 1 month after an intravitreal injection, using central retinal thickness (CRT), manual measurements, and fluid specific volumetric measurements performed by an automated algorithm based on artificial intelligence. RESULTS: A significant improvement was found at week 1 in terms of CRT (p < 0.0001), intraretinal (IRF) (p = 0.007), subretinal fluid (SRF) (p < 0.0001), and pigment epithelium detachment (PED) volume (p < 0.0001). Volumetric fluid measures revealed a >50% reduction at week 1 for both IRF and SRF for approximately two-thirds of eyes. Poorer short-term response was associated with larger exudative fluid amounts (IRF + SRF) (p = 0.003), larger PED (p = 0.007), lower visual acuity (p = 0.004) and less anatomic changes at treatment initiation (p < 0.0001). Univariate and multivariate analysis revealed that visual outcomes 4 and 5 years later was significantly worse with weaker short-term responsiveness (p = 0.005), with the presence of atrophy (p = 0.01) and larger PED volumes (p = 0.002). CONCLUSIONS: Incomplete responders to anti-VEGF showed a significant short-term response, identifiable at 1 week after injection, with rapid recurrence at 1 month. Weaker short-term responsiveness at 1 week was associated with poorer long term visual prognosis. These patients may need adjuvant treatment to improve their prognosis.


Asunto(s)
Inhibidores de la Angiogénesis , Inyecciones Intravítreas , Ranibizumab , Líquido Subretiniano , Tomografía de Coherencia Óptica , Factor A de Crecimiento Endotelial Vascular , Agudeza Visual , Degeneración Macular Húmeda , Humanos , Inhibidores de la Angiogénesis/uso terapéutico , Masculino , Estudios Retrospectivos , Femenino , Tomografía de Coherencia Óptica/métodos , Agudeza Visual/fisiología , Anciano , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Pronóstico , Degeneración Macular Húmeda/tratamiento farmacológico , Degeneración Macular Húmeda/fisiopatología , Degeneración Macular Húmeda/diagnóstico , Anciano de 80 o más Años , Ranibizumab/uso terapéutico , Ranibizumab/administración & dosificación , Bevacizumab/uso terapéutico , Persona de Mediana Edad , Receptores de Factores de Crecimiento Endotelial Vascular/uso terapéutico
19.
Br J Ophthalmol ; 108(2): 253-262, 2024 01 29.
Artículo en Inglés | MEDLINE | ID: mdl-36627173

RESUMEN

AIM: To explore associations between artificial intelligence (AI)-based fluid compartment quantifications and 12 months visual outcomes in OCT images from a real-world, multicentre, national cohort of naïve neovascular age-related macular degeneration (nAMD) treated eyes. METHODS: Demographics, visual acuity (VA), drug and number of injections data were collected using a validated web-based tool. Fluid compartment quantifications including intraretinal fluid (IRF), subretinal fluid (SRF) and pigment epithelial detachment (PED) in the fovea (1 mm), parafovea (3 mm) and perifovea (6 mm) were measured in nanoliters (nL) using a validated AI-tool. RESULTS: 452 naïve nAMD eyes presented a mean VA gain of +5.5 letters with a median of 7 injections over 12 months. Baseline foveal IRF associated poorer baseline (44.7 vs 63.4 letters) and final VA (52.1 vs 69.1), SRF better final VA (67.1 vs 59.0) and greater VA gains (+7.1 vs +1.9), and PED poorer baseline (48.8 vs 57.3) and final VA (55.1 vs 64.1). Predicted VA gains were greater for foveal SRF (+6.2 vs +0.6), parafoveal SRF (+6.9 vs +1.3), perifoveal SRF (+6.2 vs -0.1) and parafoveal IRF (+7.4 vs +3.6, all p<0.05). Fluid dynamics analysis revealed the greatest relative volume reduction for foveal SRF (-16.4 nL, -86.8%), followed by IRF (-17.2 nL, -84.7%) and PED (-19.1 nL, -28.6%). Subgroup analysis showed greater reductions in eyes with higher number of injections. CONCLUSION: This real-world study describes an AI-based analysis of fluid dynamics and defines baseline OCT-based patient profiles that associate 12-month visual outcomes in a large cohort of treated naïve nAMD eyes nationwide.


Asunto(s)
Mácula Lútea , Degeneración Macular , Desprendimiento de Retina , Degeneración Macular Húmeda , Humanos , Ranibizumab/uso terapéutico , Inhibidores de la Angiogénesis/uso terapéutico , Factor A de Crecimiento Endotelial Vascular , Inteligencia Artificial , Tomografía de Coherencia Óptica , Inyecciones Intravítreas , Desprendimiento de Retina/tratamiento farmacológico , Degeneración Macular/tratamiento farmacológico , Líquido Subretiniano , Degeneración Macular Húmeda/diagnóstico , Degeneración Macular Húmeda/tratamiento farmacológico
20.
Ophthalmic Epidemiol ; 31(1): 94-97, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-36794374

RESUMEN

PURPOSE: We investigate the impact of COVID-19 and lockdowns on anti-vascular endothelial growth factor (anti-VEGF) treatment for neovascular age-related macular degeneration (AMD) in Victoria (Australian state with highest burden of COVID-19 in 2020) and Australia, by examining anti-VEGF prescriptions supplied for AMD treatment between 2018 and 2020. METHODS: We performed a retrospective, population-based analysis of aflibercept and ranibizumab prescriptions supplied for the treatment of AMD in Victoria and Australia between 1 January 2018 and 31 December 2020, as recorded by the Pharmaceutical Benefits Scheme (PBS) and Repatriation PBS, the Australian Government program subsidising medication costs for Australian residents and veterans. Poisson models and univariate regression were used to descriptively examine trends in monthly anti-VEGF prescription rates with time and changes in monthly prescription rates (prescription rate ratios [RR]). RESULTS: In 2020, anti-VEGF AMD prescription rates in Victoria decreased by 18% during the nationwide lockdown between March and May (RR 0.82, 95% CI: 0.80-0.85, p < .001), and by 24% during the Victorian-specific lockdown between July and October (RR 0.76, 95% CI: 0.73-0.78, p < .001). In Australia, prescription rates tended to decrease between January and October 2020, reducing by 25% (RR 0.75, 95% CI: 0.74-0.77, p < .001) between these months, including between March and April (RR 0.94, 95% CI: 0.92-0.95, p < .001) but not April and May (RR 1.10, 95% CI: 1.09-1.12, p < .001). CONCLUSION: In 2020, anti-VEGF prescriptions for AMD treatment decreased modestly in Victoria during both lockdowns and in Australia during the year. Decreases may represent reduced treatment because of COVID-19, including public health orders, patients' self-limiting care, and ophthalmologists treating-and-extending to maximum intervals.


Asunto(s)
COVID-19 , Degeneración Macular , Degeneración Macular Húmeda , Humanos , Inhibidores de la Angiogénesis/uso terapéutico , Factor A de Crecimiento Endotelial Vascular/uso terapéutico , Estudios Retrospectivos , Inyecciones Intravítreas , Australia/epidemiología , COVID-19/epidemiología , Control de Enfermedades Transmisibles , Ranibizumab/uso terapéutico , Degeneración Macular/tratamiento farmacológico , Degeneración Macular/epidemiología , Degeneración Macular Húmeda/tratamiento farmacológico , Degeneración Macular Húmeda/epidemiología , Proteínas Recombinantes de Fusión/uso terapéutico
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