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Estudio de utilización de medicamentos biológicos ranibizumab y bevacizumab en el servicio de oftalmología del hospital nacional Edgardo Rebagliati Martins de mayo 2011 a mayo 2012Armas Loarte, Guido Simón January 2015 (has links)
Se analizó la utilización de medicamentos biológicos ranibizumab (2,3mg/0.23mL) y bevacizumab (400mg/16mL) en el Servicio de Oftalmología del Hospital Nacional Edgardo Rebagliati Martins durante el periodo mayo 2011-mayo 2012, utilizando el análisis descriptivo-retrospectivo de los reportes de consumo de Farmacia, hoja de trabajo de la Unidad de Mezclas Oncológicas e historias clínicas. Los objetivos de este estudio fueron: determinar el consumo cuantitativo y los costos del ranibizumab y bevacizumab, los resultados de la utilización de los medicamentos biológicos y describir los esquemas de tratamiento. De los 194 pacientes tratados con los medicamentos de estudio, 160 tenían como diagnóstico degeneración macular relacionado con la edad (DMRE) exudativa, 89 del sexo femenino y 71 de sexo masculino de los cuales el 55,6% están dentro del grupo etario 66-80 años. En total, se administraron 319 dosis (319 viales) de ranibizumab y 83 dosis (12 viales) de bevacizumab generando un gasto de S/. 907992,6 nuevo soles de los cuales, aproximadamente, el 93.3% lo genera el ranibizumab. El costo promedio el tratamiento farmacológico de la DMRE exudativa con ranibizumab es S/.5310,00 y con bevacizumab es S/.606.88 nuevo soles. Los pacientes con DMRE exudativa tratados con ranibizumab + bevacizumab y ranibizumab tuvieron una buena evolución en un 32% y 22% respectivamente. La principal prescripción del ranibizumab como monoterapia y en combinación con bevacizumab fue DMRE exudativa y para el bevacizumab (monoterapia) fue retinopatía diabética y edema macular. La DMRE exudativa fue tratada como mínimo 1 mes y como máximo por 12,4 meses durante el cual se administraron en promedio 2,3 números de dosis con intervalos de tiempo que va de 0,9 meses a 9,9 meses de una dosis a otra. / --- The use of biological drugs Ranibizumab (2,3mg/0,23ml) and Bevacizumab (400mg/16ml) was analyzed at the Ophthalmology Service from the National Hospital Edgardo Rebagliati Martins during the period May 2011 – May 2012, using the descriptive – retrospective analysis of the consumer reports of Pharmacy, worksheet of the Oncological Mixtures Unit and medical records. The objectives of the study were: determine the quantitative consumption and the costs of Ranibizumab and Bevacizumab, the results using biological drugs and describe the treatment schemes. Of the 194 total patients treated with the study drugs, 160 had a diagnosis of macular degeneration associated with age (MDAA) exudative, 89 of them female sex and 71 male sex of which 55,6% are in the age group of 66 – 80 years old. A total of, 319 doses (319 vials) of Ranibizumab and 83 doses (12 vials) of Bevacizumab were administered generating an expense of S/. 907992,6 of which approximately 93.3% was generated by Ranibizumab. The average cost for the pharmacological treatment of MDAA exudative with Ranibizumab and Bevacizumab are of S/.5310,00 and S/.606,88 respectively. The patients with MDAA exudative treated with Ranibizumab + Bevacizumab and with just Ranibizumab had a good performance by 32% and 22% respectively. The main prescription of Ranibizumab as monotherapy and in combination with Bevacizumab was for MDAA exudative, and of Bevacizumab (monotherapy) was for diabetic retinopathy and macular edema. The MDAA exudative was treated 1 month as minimum and 12,4 months at the most during which were administered an average of 2,3 numbers of doses with time intervals of 0,9 months up to 9,9 months between each dose.
Key words: Ranibizumab, Bevacizumab, antiangiogenic agents, macular degeneration associated with age exudative and choroidal neovascularization.
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Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES) - Eine dreiarmige klinische Studie zur Wirksamkeit von Ranibizumab (Lucentis®) im Vergleich zur alleinigen GRID-Laserkoagulation und einer Kombination aus beiden Therapien zur Behandlung des chronischen Makulaödems nach retinalem Venenastverschluss / Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES) - A three-armed clinical study on the effectiveness of ranibizumab (Lucentis®) compared to sole grid laser coagulation and a combination of both therapies in treatment of chronic macular edema secondary to branch retinal vein occlusionSchäfer, Caroline 14 January 2013 (has links)
No description available.
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Risk of elevated intraocular pressure after ranibizumab injection in patients with neovascular age-related macular degenerationMoghadaszadeh, Solmaz 01 1900 (has links)
Objectif : Nous avons voulu évaluer le risque d’élévation chronique de la pression intraoculaire suite à des injections de ranibizumab dans le traitement de la dégénérescence maculaire liée à l’âge de type néovasculaire. Méthode : Nous avons réalisé une étude rétrospective sur 161 patients ayant reçu des injections de ranibizumab dans un œil seulement. Les critères excluent les patients ayant du glaucome non contrôlé au départ (PIO>21mmHg) et ceux qui ont eu moins de 9 semaines de suivi après l’injection. L’élévation de la PIO est définie comme une augmentation de >5mmHg sur deux visites consécutives. Résultats : Nous n’avons pas déterminé de différence de pourcentage entre les yeux ayant reçus des injections pour lesquels il y a une élévation de la PIO (n=8.5%), comparé au pourcentage de yeux n’ayant pas reçus d’injections pour lesquels il y a une élévation de la PIO (n=9.6%). Cependant, un plus grand nombre d’injections d’anti-VEGF est associé avec une élévation chronique de la PIO (P=0.032). D’autres facteurs de risque de l’élévation chronique de la PIO sont le diabète, une PIO faible au départ, et une PIO maximale plus élevée (P<0.05). Conclusion : Un plus grand nombre d’injections semble augmenter le risque d’élévation de la PIO. Les patients atteints de diabète semblent être plus à risque et nécessiter une étroite surveillance. / Purpose: Conflicting evidence exists about the risk of chronic elevation of intraocular pressure (IOP) after ranibizumab injections for neovascular age-related macular degeneration. The goal of this study is to evaluate this risk.
Methods: A retrospective cohort study of 161 people. Inclusion criteria included receiving at least three ranibizumab injections in one eye only and having at least 9 weeks of follow-up. Exclusion criteria included the presence of uncontrolled glaucoma or ocular hypertension at baseline (IOP>=21mmHg). Chronic IOP elevation was defined as an increase >5mmHg of IOP on at least 2 consecutive visits.
Results: There was no difference in the percentage of injected eyes that experienced a chronic IOP increase (n=8, 5%) compared to the percentage of uninjected eyes that experienced an IOP increase (n=9, 6%). However, a greater number of anti-VEGF injections was associated with chronic IOP elevation (P=0.032). Other risk factors for chronic IOP elevation included diabetes, a lower baseline IOP, and a higher maximum IOP (P<0.05).
Conclusions: A greater number of injections appears to increase the risk of chronic IOP elevation. Also, diabetics appear to be more at risk and may need more careful follow-up or preventive pharmacological treatment.
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Wirksamkeit von Ranibizumab bei Patienten mit Chorioidaler Neovaskularisation (CNV) bei altersabhängiger Makuladegeneration (AMD) -RABIMO- / Efficacy of ranibizumab treatment regimen in eyes with neovascular age-related macular degeneration -RABIMO-Bretag, Mirko 10 January 2018 (has links)
No description available.
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Qualidade de vida visual em pacientes com degeneração macular relacionada à idade neovascular tratados com antiangiogênicos / Vision-related quality of life in neovascular age-related macular degeneration patients treated with antiangiogenicsRamalho, Reinaldo Flávio da Costa 07 August 2018 (has links)
INTRODUÇÃO: A degeneração macular relacionada à idade (DMRI) é a principal causa de perda de visão irreversível e cegueira mundialmente. A perda da visão central interfere nas atividades de vida diária, como o reconhecimento facial, leitura e escrita, direção de veículos automotores e em atividades funcionais e de lazer. Esta perda de visão relaciona-se também com o desencadeamento de quadros de ansiedade e depressão. Este estudo avaliou a qualidade de vida visual em pacientes com degeneração macular relacionada à idade neovascular por meio do questionário de função visual 25-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25). MÉTODOS: Estudo clínico observacional de 87 pacientes de ambos os sexos, com idade >= 50 anos e com o diagnóstico de DMRI neovascular unilateral ou bilateral. Todos os pacientes responderam ao questionário de função visual NEI VFQ- 25 no final do tratamento em regime Tratar e Estender ou PrONTO, com as drogas antiangiogênicas ranibizumabe ou aflibercepte. RESULTADOS: A idade dos pacientes foi a variável que menos influenciou a qualidade de vida visual dos pacientes. O gênero teve uma influência um pouco maior que a idade, no entanto, a lateralidade da doença demonstrou maior influência na qualidade de vida visual, comparada ao gênero e idade dos pacientes e foi significante para oito dos 12 domínios do questionário de função visual NEI VFQ-25. Os pacientes com acometimento bilateral tiveram pontuações mais baixas que os com doença unilateral em todos os domínios do questionário. A acuidade visual corrigida (AVc) foi a variável que apresentou o maior número de domínios com valores significantes e, portanto, foi a variável que mais se correlacionou com a qualidade de vida visual. A AVc do melhor olho (MO) foi significante para a maioria dos domínios relacionados com a visão, ao contrário do pior olho (PO) que não foi significante para nenhum domínio do questionário. CONCLUSÃO: Todas as variáveis testadas afetaram a qualidade de vida visual dos pacientes, onde a lateralidade teve uma maior influência, seguida pela idade e sexo dos pacientes. Na tomada de decisão para o tratamento de pacientes com DMRI neovascular, pelo menos para esta população, a manutenção da AVc do MO >= 0,5 (escala decimal de Snellen) foi essencial para a manutenção de boa qualidade de vida visual, independente da AVc do PO, que não teve efeito significante em nenhum domínio do questionário de função visual NEI VFQ-25 / INTRODUCTION: The neovascular age-related macular degeneration (AMD) is the main cause of irreversible loss of vision and blindness woldwide. The loss of the central visual field interferes on daily activities such as facial recognition, reading and writing, driving as well as functional and leasure activities. This loss of vision may also increases anxiety and depression for this age group. To evaluate the impact of neovascular AMD on the visual quality of life of patients using the 25-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25). METHODS: This was an observational clinical, with 87 patients of both genders, with age >= 50 years and a clinical diagnosis of unilateral or bilateral neovascular age related macular degeneration. All patients answered the visual functioning questionaire NEI VFQ-25 at the end of the treatment with the Treat and Extend or PrONTO regimen using antiangiogenic drugs ranibizumab or aflibercept. RESULTS: The age of patients was the variable with the lower influence on the quality of life of the patients. Gender had an influence slightly higher then the age, however, the laterality of the disease had the highest influence on the quality of life, compared with age and gender, and was significant for 8 of the 12 domains of the visual functioning questionaire NEI VFQ-25. The patients with bilateral age-related macular degeneration had lower scores than patients with unilateral disease for all domains of the questionaire. Visual acuity was the variable with the higher number of domains with significant values, and therefore the variable with the higher correlation with the quality of life. The visual acuity of the best eye (BE) was significant for most of the vision related domains, in opposition the the visual acuity of the worst eye (WE) which was not significant for any domain of the questionaire. CONCLUSION: All variables tested affected the visual quality of life, where the laterality of the disease had the highest influence, followed by the age and gender of the patients. The decision process for the treatment of patients with neovascular AMD, at least for this population, keeping the visual acuity of the BE >= 0,5 (Snellen\'s decimal scale) was essential to maintain a long term quality of life, despite the visual acuity of the worst eye, that had no significant effect on any domain of the visual functioning quaestionaire NEI VFQ-25
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Qualidade de vida visual em pacientes com degeneração macular relacionada à idade neovascular tratados com antiangiogênicos / Vision-related quality of life in neovascular age-related macular degeneration patients treated with antiangiogenicsReinaldo Flávio da Costa Ramalho 07 August 2018 (has links)
INTRODUÇÃO: A degeneração macular relacionada à idade (DMRI) é a principal causa de perda de visão irreversível e cegueira mundialmente. A perda da visão central interfere nas atividades de vida diária, como o reconhecimento facial, leitura e escrita, direção de veículos automotores e em atividades funcionais e de lazer. Esta perda de visão relaciona-se também com o desencadeamento de quadros de ansiedade e depressão. Este estudo avaliou a qualidade de vida visual em pacientes com degeneração macular relacionada à idade neovascular por meio do questionário de função visual 25-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25). MÉTODOS: Estudo clínico observacional de 87 pacientes de ambos os sexos, com idade >= 50 anos e com o diagnóstico de DMRI neovascular unilateral ou bilateral. Todos os pacientes responderam ao questionário de função visual NEI VFQ- 25 no final do tratamento em regime Tratar e Estender ou PrONTO, com as drogas antiangiogênicas ranibizumabe ou aflibercepte. RESULTADOS: A idade dos pacientes foi a variável que menos influenciou a qualidade de vida visual dos pacientes. O gênero teve uma influência um pouco maior que a idade, no entanto, a lateralidade da doença demonstrou maior influência na qualidade de vida visual, comparada ao gênero e idade dos pacientes e foi significante para oito dos 12 domínios do questionário de função visual NEI VFQ-25. Os pacientes com acometimento bilateral tiveram pontuações mais baixas que os com doença unilateral em todos os domínios do questionário. A acuidade visual corrigida (AVc) foi a variável que apresentou o maior número de domínios com valores significantes e, portanto, foi a variável que mais se correlacionou com a qualidade de vida visual. A AVc do melhor olho (MO) foi significante para a maioria dos domínios relacionados com a visão, ao contrário do pior olho (PO) que não foi significante para nenhum domínio do questionário. CONCLUSÃO: Todas as variáveis testadas afetaram a qualidade de vida visual dos pacientes, onde a lateralidade teve uma maior influência, seguida pela idade e sexo dos pacientes. Na tomada de decisão para o tratamento de pacientes com DMRI neovascular, pelo menos para esta população, a manutenção da AVc do MO >= 0,5 (escala decimal de Snellen) foi essencial para a manutenção de boa qualidade de vida visual, independente da AVc do PO, que não teve efeito significante em nenhum domínio do questionário de função visual NEI VFQ-25 / INTRODUCTION: The neovascular age-related macular degeneration (AMD) is the main cause of irreversible loss of vision and blindness woldwide. The loss of the central visual field interferes on daily activities such as facial recognition, reading and writing, driving as well as functional and leasure activities. This loss of vision may also increases anxiety and depression for this age group. To evaluate the impact of neovascular AMD on the visual quality of life of patients using the 25-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25). METHODS: This was an observational clinical, with 87 patients of both genders, with age >= 50 years and a clinical diagnosis of unilateral or bilateral neovascular age related macular degeneration. All patients answered the visual functioning questionaire NEI VFQ-25 at the end of the treatment with the Treat and Extend or PrONTO regimen using antiangiogenic drugs ranibizumab or aflibercept. RESULTS: The age of patients was the variable with the lower influence on the quality of life of the patients. Gender had an influence slightly higher then the age, however, the laterality of the disease had the highest influence on the quality of life, compared with age and gender, and was significant for 8 of the 12 domains of the visual functioning questionaire NEI VFQ-25. The patients with bilateral age-related macular degeneration had lower scores than patients with unilateral disease for all domains of the questionaire. Visual acuity was the variable with the higher number of domains with significant values, and therefore the variable with the higher correlation with the quality of life. The visual acuity of the best eye (BE) was significant for most of the vision related domains, in opposition the the visual acuity of the worst eye (WE) which was not significant for any domain of the questionaire. CONCLUSION: All variables tested affected the visual quality of life, where the laterality of the disease had the highest influence, followed by the age and gender of the patients. The decision process for the treatment of patients with neovascular AMD, at least for this population, keeping the visual acuity of the BE >= 0,5 (Snellen\'s decimal scale) was essential to maintain a long term quality of life, despite the visual acuity of the worst eye, that had no significant effect on any domain of the visual functioning quaestionaire NEI VFQ-25
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Development and comparison of bioanalytical methods to measure free analytePihlblad, Alma January 2020 (has links)
Free analyte is measured to be able to understand the pharmacological effects of a drug in the body, the binding to its ligand, and the effective drug level among other things. Thereby, it is important with correct measurements of free analyte, although it is not that easy to achieve since overestimations can occur. In this project, several immunoassays were developed for the bioanalytical methods Gyrolab and ELISA to measure free analyte, where the biotherapeutics Avastin® and Lucentis®, and the ligand VEGF were used as analytes. One difference between the methods is the short contact time of just a few seconds for Gyrolab compared to the sample incubation time of a couple of hours for ELISA. One difference between the antibodies is that Lucentis is an affinity-matured Fab region, and therefore, has a stronger affinity to VEGF compared to Avastin. When free Avastin was measured, the difference was significant, with ELISA estimating higher concentrations compared to Gyrolab. However, this was not the case for all assays. In some cases, this was probably due to differences between the methods that could not be seen. Otherwise, the results with no difference between the methods, when measuring free analyte with Lucentis as the drug, were expected due to the stronger affinity and longer halftime of dissociation. However, the difference with the longer sample incubation time for ELISA compared to the short contact time for Gyrolab seems to influence the measurement of free analyte, depending on the affinity of the components being measured.
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Evaluation der intravitrealen Injektionen bei retinalen Venenverschlüssen mit geringem initialen VisusAhnert, Rebecca 28 April 2020 (has links)
Retinale
Venenverschlüsse
kann
man
in
Astvenenverschlüsse
und
Zentralvenenverschlüsse unterteilen. Beide Erkrankungen werden primär mit intravitrealen
Injektionen behandelt, wie den Anti-VEGF-Antikörpern oder dexametasonhaltigen
Implantaten. Ziel dieser Arbeit ist die Evaluation der Therapiewirksamkeit von Anti-VEGF-
Injektionen bei Patienten mit geringem Visus von ≤ 0,2 bei Behandlungsbeginn anhand
von OCT und Visus von 150 Patienten im Behandlungsverlauf von bis zu zwölf Monaten.
Die Gruppe der Patienten mit Baseline-Visus >0,2 stellt dabei die Vergleichsgruppe dar.
In der Patientengruppe A mit Visus ≤ 0,2 bei ZVV stellte sich ein Visusanstieg von 0,10 auf
0,20 ± 0,18 nach zwölf Monaten ein. Im Patientenkollektiv B mit Visus >0,2 und ZVV stellte
sich eine Visusbesserung von 0,43 auf 0,61 ± 0,27 ein.
In der Patientengruppe A mit Visus ≤ 0,2 bei VAV stellte sich ein Visusanstieg von 0,11 auf
0,27 ± 0,07 nach zwölf Monaten ein. Im Patientenkollektiv mit Visus > 0,2 und VAV stellte
sich eine Visusbesserung von 0,52 auf 0,68 ± 0,18 ein. Damit ist bei allen Gruppen eine
signifikante Visusverbesserung nachweisbar, wobei es ersichtlich ist, dass der bessere
initiale Visus auch einen besseren Endvisus determiniert.
Bei der Patientengruppe mit Anfangsvisus ≤ 0,2 konnte signifikant eine größere absolute
Netzhautdickenabnahme bei stets höherer Netzhautdicke als in der Referenzgruppe
nachgewiesen werden.:Inhaltsverzeichnis
1 Einleitung..........................................................................................................................1
1.1 Netzhautanatomie.....................................................................................................1
1.1.1 Blutversorgung der Netzhaut...............................................................................2
1.1.2 Venenverschlüsse der Retina..............................................................................3
1.2 Makulaödem..............................................................................................................7
1.3 Der molekulare Signalweg beim Makulaödem......................................................8
1.4 Diagnostik................................................................................................................10
1.4.1 Symptome.........................................................................................................10
1.4.2 Sehschärfenprüfung..........................................................................................10
1.4.3 .Ophthalmoskopie..............................................................................................11
1.4.4 Bildgebende Diagnostik.....................................................................................12
1.4.4.1 Fluoreszeinangiographie............................................................................12
1.4.4.2 Optische Kohärenz-Tomografie.................................................................13
1.5 Therapie der Venenverschlüsse............................................................................15
1.5.1 Intravitreale Injektionen.....................................................................................15
1.5.1.1 VEGF-Antikörper........................................................................................16
Bevacizumab.....................................................................................................17
Ranibizumab......................................................................................................17
Aflibercept..........................................................................................................17
1.5.1.2 Therapieschemata von intravitrealen Anti-VEGF-Injektionen....................18
1.5.1.3 Kortikosteroide...........................................................................................19
1.5.2 Laserkoagulation...............................................................................................20
Fokale Laserkoagulation....................................................................................20
Periphere Laserkoagulation...............................................................................21
1.6 Prognose.................................................................................................................21
2 Arbeitshypothese und Fragestellung..........................................................................23
3 Materialien und Methoden.............................................................................................24
3.1 Behandlungsablauf................................................................................................24
3.2 Patientenkollektiv und Statistik............................................................................26
4 Ergebnisse......................................................................................................................27
4.1 Patientenkollektiv...................................................................................................27
Demografie des Patientenkollektivs...................................................................30
4.2 Art der Behandlung................................................................................................35
4.3 Laserkoagulation....................................................................................................40
4.4 Patientengruppe Lucentis und ZVV......................................................................41
4.5 Patientengruppe Lucentis und VAV......................................................................49
5 Diskussion......................................................................................................................54
6 Zusammenfassung der Arbeit......................................................................................59
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Estudo comparativo de fotocoagulação panretiniana com e sem ranibizumabe intravítreo no tratamento da retinopatia diabética proliferativa / A comparative study of panretinal photocoagulation with and without intravitreal ranibizumab in treatment of proliferative diabetic retinopathyFerraz, Daniel Araujo 28 August 2015 (has links)
Objetivo: Comparar o efeito da terapia da fotocoagulação panretiniana (PFC) associada à injeção intravítrea de Ranibizumabe (RBZ) versus terapia isolada com PFC em pacientes com retinopatia diabética proliferativa (RDP) precoce, virgens de tratamento, com ou sem edema macular diabético (DME) durante 6 meses de acompanhamento. Projeto: Estudo prospectivo intervencionista, randomizado e controlado. Métodos: Sessenta olhos de 30 pacientes com RDP bilateral precoce foram randomizados para o grupo de estudo (GE) que foram tratados com PFC associado a duas injeções de RBZ intravítreo (0.5mg/0.05ml) ou para o grupo controle (GC) tratados apenas com PFC. Mudanças na acuidade visual (AV) corrigida, na sensibilidade ao contraste (SC) e na espessura foveal (EF) foram comparados no início, e nos 1, 3 e 6 meses após o tratamento. Resultados: No GE, a diferença na média da AV do baseline para o mês 6 teve um aumento significativo de + 3,4 letras (p = 0,006) e uma diminuição significativa na EF de - 47.6um (p < 0,001). No GC, a diferença na média da AV teve uma diminuição de - 3,4 letras (p = 0,04) e uma mudança na EF de -3.8 um (p = 0,96). Com relação ao teste de SC dentre os 28 olhos do GE, houve uma melhora no mês 6 em relação ao baseline nos ciclos: 1,5 (p < 0.001) e 3,0 ciclo (p=0.023). Dentre os 30 olhos do GC, não houve uma diferença estatística nos momentos estudados. Conclusão: A injeção intravítrea de RBZ associado com PFC pode ser um tratamento eficaz em olhos de pacientes com RDP precoce e EMD / Purpose: To compare the efficacy of therapy with panretinal photocoagulation (PRP) and intravitreal ranibizumab (RBZ) injection versus PRP alone in patients with treatment-naive bilateral non-high risk proliferative diabetic retinopathy (PDR) with and without diabetic macular edema (DME) with a 6-month follow-up. Design: Prospective, interventional, randomized controlled trial. Methods: Sixty eyes of 30 patients with bilateral non-high risk PDR were randomized either to the study group (SG) receiving PRP plus two intravitreal ranibizumab injections (0.5mg/0.05ml), the first one week before and the second four weeks after the PRP or to the control group (CG) receiving PRP alone. Mean change in best-corrected visual acuity (BCVA), contrast sensitivity (CS) and central macular thickness (CMT) were compared at baseline and 1, 3 and 6 months after treatment. Results: Changes from baseline to 6 months showed in the SG an increased in the BCVA by + 3.4 letters (p= 0.006) with a decrease in CMT by - 47.6um (p < 0.001). In the CG, a decrease by - 3.4 letters (p = 0.04) and an decrease by -3.8um (p= 0.96). Regarding the CS in the SG, there was an improvement compared to baseline for the sixth month in the 1.5 (p < 0.001) and 3.0 cycles (p = 0.023). The CG did not show significant results from baseline to month 6. Conclusion: Intravitreal RBZ associated with PRP can be an effective treatment in eyes with non-high risk PDR and DME
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Estudo comparativo de fotocoagulação panretiniana com e sem ranibizumabe intravítreo no tratamento da retinopatia diabética proliferativa / A comparative study of panretinal photocoagulation with and without intravitreal ranibizumab in treatment of proliferative diabetic retinopathyDaniel Araujo Ferraz 28 August 2015 (has links)
Objetivo: Comparar o efeito da terapia da fotocoagulação panretiniana (PFC) associada à injeção intravítrea de Ranibizumabe (RBZ) versus terapia isolada com PFC em pacientes com retinopatia diabética proliferativa (RDP) precoce, virgens de tratamento, com ou sem edema macular diabético (DME) durante 6 meses de acompanhamento. Projeto: Estudo prospectivo intervencionista, randomizado e controlado. Métodos: Sessenta olhos de 30 pacientes com RDP bilateral precoce foram randomizados para o grupo de estudo (GE) que foram tratados com PFC associado a duas injeções de RBZ intravítreo (0.5mg/0.05ml) ou para o grupo controle (GC) tratados apenas com PFC. Mudanças na acuidade visual (AV) corrigida, na sensibilidade ao contraste (SC) e na espessura foveal (EF) foram comparados no início, e nos 1, 3 e 6 meses após o tratamento. Resultados: No GE, a diferença na média da AV do baseline para o mês 6 teve um aumento significativo de + 3,4 letras (p = 0,006) e uma diminuição significativa na EF de - 47.6um (p < 0,001). No GC, a diferença na média da AV teve uma diminuição de - 3,4 letras (p = 0,04) e uma mudança na EF de -3.8 um (p = 0,96). Com relação ao teste de SC dentre os 28 olhos do GE, houve uma melhora no mês 6 em relação ao baseline nos ciclos: 1,5 (p < 0.001) e 3,0 ciclo (p=0.023). Dentre os 30 olhos do GC, não houve uma diferença estatística nos momentos estudados. Conclusão: A injeção intravítrea de RBZ associado com PFC pode ser um tratamento eficaz em olhos de pacientes com RDP precoce e EMD / Purpose: To compare the efficacy of therapy with panretinal photocoagulation (PRP) and intravitreal ranibizumab (RBZ) injection versus PRP alone in patients with treatment-naive bilateral non-high risk proliferative diabetic retinopathy (PDR) with and without diabetic macular edema (DME) with a 6-month follow-up. Design: Prospective, interventional, randomized controlled trial. Methods: Sixty eyes of 30 patients with bilateral non-high risk PDR were randomized either to the study group (SG) receiving PRP plus two intravitreal ranibizumab injections (0.5mg/0.05ml), the first one week before and the second four weeks after the PRP or to the control group (CG) receiving PRP alone. Mean change in best-corrected visual acuity (BCVA), contrast sensitivity (CS) and central macular thickness (CMT) were compared at baseline and 1, 3 and 6 months after treatment. Results: Changes from baseline to 6 months showed in the SG an increased in the BCVA by + 3.4 letters (p= 0.006) with a decrease in CMT by - 47.6um (p < 0.001). In the CG, a decrease by - 3.4 letters (p = 0.04) and an decrease by -3.8um (p= 0.96). Regarding the CS in the SG, there was an improvement compared to baseline for the sixth month in the 1.5 (p < 0.001) and 3.0 cycles (p = 0.023). The CG did not show significant results from baseline to month 6. Conclusion: Intravitreal RBZ associated with PRP can be an effective treatment in eyes with non-high risk PDR and DME
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