ABSTRACT
AIMS: To analyze contrast sensitivity of intravitreal bevacizumab injections with optimizing glycemic control versus optimizing glycemic control (in combination with sham injections) in eyes with Diabetic Macular Edema (DME). DESIGN: Prospective, interventional, masked, randomized controlled trial. METHODS: Forty-one eyes of 34 patients with type 2 diabetes mellitus and DME with glycated hemoglobin (HbA1c)â¯<â¯11% received either intravitreal bevacizumab injection (Group 1) or sham injection (Group 2) at 0 and 6â¯weeks along with optimizing glycemic control. Mean change in best-corrected visual acuity (BCVA), contrast sensitivity (CS), optical coherence tomography (OCT)-measured by central macular thickness (CMT) were compared and correlated at baseline, 2, 6 and 12â¯weeks. RESULTS: The study showed a mean CS improved in group 1 from 1.14⯱â¯0.36 logCS to 1.32⯱â¯0.24 logCS and also in group 2 from 1.11⯱â¯0.29 logCS to 1.18⯱â¯0.29 logCS at 12â¯weeks (Pâ¯=â¯0.12). CS and CMT promptly decreased in group 1 compared to group 2 at 2â¯weeks (ΔCSâ¯=â¯0.15⯱â¯0.25 vs. 0.03⯱â¯0.15 logCS; Pâ¯=â¯0.04; ΔCMTâ¯=â¯116⯱â¯115 vs. 17⯱â¯71⯵m; Pâ¯=â¯0.01). There was a mean reduction of approximately 0.5% in HbA1c levels in both groups at 12â¯weeks (Pâ¯=â¯0.002). CONCLUSION: The use of bevacizumab in combination with optimizing glycemic control results in earlier improvement of contrast sensitivity in type 2 diabetes patients with DME. However, the optimizing glycemic control itself has shown also to be effective at 12â¯weeks. ClinicalTrials.gov Identifier: NCT02308644.
Subject(s)
Angiogenesis Inhibitors/therapeutic use , Bevacizumab/therapeutic use , Diabetes Mellitus, Type 2/drug therapy , Intravitreal Injections/methods , Macular Edema/drug therapy , Aged , Angiogenesis Inhibitors/pharmacology , Bevacizumab/pharmacology , Contrast Sensitivity , Diabetes Mellitus, Type 2/pathology , Female , Humans , Macular Edema/pathology , Male , Middle Aged , Prospective Studies , Treatment OutcomeABSTRACT
OBJECTIVES: Chemical pleurodesis is an important therapeutic tool to control recurrent malignant pleural effusion. Among the various sclerosing agents, iodopovidone is considered effective and safe. However, in a recent study, ocular changes were described after iodopovidone was used in recurrent pneumothorax. The aim of the study was to evaluate the efficacy and morbidity of iodopovidone pleurodesis in an experimental model. METHODS: New Zealand rabbits were submitted to intrapleural injection of iodopovidone at concentrations of 2%, 4% and 10%. Biochemical (lactic dehydrogenase, proteins, triiodothyronine, free thyroxine, urea and creatinine) and immunological (Interleukin-8 [IL-8], VEGF and TGFß) parameters were measured in the pleural fluid and blood. After 1, 3, 7, 14 and 28 days, groups of animals were euthanized, and macro- (pleura) and microscopic (pleura and retina) analyses were performed. RESULTS: An early pleural inflammatory response with low systemic repercussion was observed without corresponding changes in thyroid or renal function. The higher concentrations (4% and 10%) correlated with greater initial exudation, and maximum pleural thickening was observed after 28 days. No changes were observed in the retinal pigment epithelium of the rabbits. CONCLUSION: Iodopovidone is considered to be an effective and safe sclerosing agent in this animal model. However, its efficacy, tolerance and safety in humans should be further evaluated.
Subject(s)
Pleural Effusion, Malignant/therapy , Pleurodesis/methods , Povidone-Iodine/administration & dosage , Sclerosing Solutions/administration & dosage , Animals , Cytokines/blood , Enzyme-Linked Immunosorbent Assay , Models, Animal , Pleura/drug effects , Povidone-Iodine/adverse effects , Rabbits , Retinal Pigment Epithelium/drug effects , Sclerosing Solutions/adverse effects , Time FactorsABSTRACT
PURPOSE: To compare the intravitreal pharmacokinetic profile of a triamcinolone acetonide formulation containing the preservative benzyl alcohol (TA-BA) versus a preservative-free triamcinolone acetonide formulation (TA-PF), and evaluate potential signs of toxicity to the retina. METHODS: A total of 60 New Zealand male white rabbits, divided into two groups, were studied. In the TA-BA group, 30 rabbits received an intravitreal injection of TA-BA (4 mg/0.1 ml) into the right eye. In the TA-PF group, 30 rabbits received an intravitreal injection of TA-PF (4 mg/0.1 ml) into the right eye. The intravitreal drug levels were determined in 25 animals from each group by high-performance liquid chromatography (HPLC). The potential for toxicity associated with the intravitreal triamcinolone injections was evaluated in five randomly selected animals from each group by electroretinography (ERG) and by light microscopy. RESULTS: Median intravitreal concentrations of TA-BA (µg/ml) were 1903.1, 1213.0, 857.8, 442.0, 248.6 at 3, 7, 14, 21 and 28 days after injection. Intravitreal concentrations of TA-PF (µg/ml) were 1032.9, 570.1, 516.6, 347.9, 102.8 at 3, 7, 14, 21 and 28 days after injection. The median intravitreal triamcinolone concentration was significantly higher in the TA-BA compared to the TA-PF group at 7 days post-injection (p < 0.05). There was no significant difference between the two groups in median triamcinolone concentration at the other time points evaluated. There was no evidence of toxic effects on the retina in either group based on ERG or histological analyses. CONCLUSIONS: Following a single intravitreal injection, the median concentration of triamcinolone acetonide is significantly higher in the TA-BA compared to the TA-PF group at 7 days post-injection. No toxic reactions in the retina were observed in either group.
Subject(s)
Macular Degeneration/drug therapy , Retina/drug effects , Triamcinolone Acetonide/pharmacokinetics , Vitreous Body/metabolism , Animals , Chromatography, High Pressure Liquid , Disease Models, Animal , Dose-Response Relationship, Drug , Electroretinography/drug effects , Intravitreal Injections , Macular Degeneration/metabolism , Macular Degeneration/physiopathology , Male , Rabbits , Retina/metabolism , Retina/physiopathology , Triamcinolone Acetonide/administration & dosage , Vitreous Body/drug effectsABSTRACT
OBJECTIVES: Chemical pleurodesis is an important therapeutic tool to control recurrent malignant pleural effusion. Among the various sclerosing agents, iodopovidone is considered effective and safe. However, in a recent study, ocular changes were described after iodopovidone was used in recurrent pneumothorax. The aim of the study was to evaluate the efficacy and morbidity of iodopovidone pleurodesis in an experimental model. METHODS: New Zealand rabbits were submitted to intrapleural injection of iodopovidone at concentrations of 2%, 4% and 10%. Biochemical (lactic dehydrogenase, proteins, triiodothyronine, free thyroxine, urea and creatinine) and immunological (Interleukin-8 [IL-8], VEGF and TGFβ) parameters were measured in the pleural fluid and blood. After 1, 3, 7, 14 and 28 days, groups of animals were euthanized, and macro- (pleura) and microscopic (pleura and retina) analyses were performed. RESULTS: An early pleural inflammatory response with low systemic repercussion was observed without corresponding changes in thyroid or renal function. The higher concentrations (4% and 10%) correlated with greater initial exudation, and maximum pleural thickening was observed after 28 days. No changes were observed in the retinal pigment epithelium of the rabbits. CONCLUSION: Iodopovidone is considered to be an effective and safe sclerosing agent in this animal model. However, its efficacy, tolerance and safety in humans should be further evaluated. .
Subject(s)
Animals , Rabbits , Pleural Effusion, Malignant/therapy , Pleurodesis/methods , Povidone-Iodine/administration & dosage , Sclerosing Solutions/administration & dosage , Cytokines/blood , Enzyme-Linked Immunosorbent Assay , Models, Animal , Pleura/drug effects , Povidone-Iodine/adverse effects , Retinal Pigment Epithelium/drug effects , Sclerosing Solutions/adverse effects , Time FactorsABSTRACT
Introduçäo: os pacientes de tumores oculares podem ter pior prognóstico visual e sistêmico na ocorrência de atraso diagnóstico e tratamento empreendida por esses pacientes e descrever as características demográficas e clínicas dos mesmos. Material e métodos: entrevista com pacientes portadores de tumores oculares de diagnóstico recente atendidos em hospital universitário no período de maio/95 a maio/96. Resultados: foram avaliados 37 pacientes. Os tumores malignos encontrados com maior frequência foram retinoblastoma, carcinoma epidermoide de conjuntiva e melanoma de coróide. A trajetória desde o início do quadro ocular até a terapêutica desenvolveu-se em quatro etapas principais, com problemas diferentes relatados em cada uma delas. As etapas de 1 a 3, relacionadas ..