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1.
Biomolecules ; 12(12)2022 12 06.
Artigo em Inglês | MEDLINE | ID: mdl-36551249

RESUMO

While topical corticosteroid (TCS) treatment is widely used for many skin diseases, it can trigger adverse side effects, and some of such effects can last for a long time after stopping the treatment. However, molecular changes induced by TCS treatment remain largely unexplored, although transient changes in histology and some major ECM components have been documented. Here, we investigated transcriptomic and proteomic changes induced by fluocinolone acetonide (FA) treatment in the mouse skin by conducting RNA-Seq and quantitative proteomics. Chronic FA treatment affected the expression of 4229 genes, where downregulated genes were involved in cell-cycle progression and ECM organization, and upregulated genes were involved in lipid metabolism. The effects of FA on transcriptome and histology of the skin largely returned to normal by two weeks after the treatment. Only a fraction of transcriptomic changes were reflected by proteomic changes, and the expression of 46 proteins was affected one day after chronic FA treatment. A comparable number of proteins were differentially expressed between control and FA-treated skin samples even at 15 and 30 days after stopping chronic FA treatment. Interestingly, proteins affected during and after chronic FA treatment were largely different. Our results provide fundamental information of molecular changes induced by FA treatment in the skin.


Assuntos
Fluocinolona Acetonida , Transcriptoma , Camundongos , Animais , Fluocinolona Acetonida/farmacologia , Fluocinolona Acetonida/uso terapêutico , Proteômica , Pele/metabolismo , Glucocorticoides/metabolismo , Corticosteroides/metabolismo
2.
JAMA Ophthalmol ; 140(10): e223780, 2022 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-36264290

RESUMO

This case report describes the migration of a fluocinolone acetonide implant to the anterior chamber 1 year after it was placed.


Assuntos
Fluocinolona Acetonida , Glaucoma , Humanos , Fluocinolona Acetonida/efeitos adversos , Pressão Intraocular , Câmara Anterior , Implantes de Medicamento/efeitos adversos
3.
Am J Otolaryngol ; 43(5): 103573, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35988360

RESUMO

PURPOSE: To describe the pharmacokinetics (PK) of ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 % otic solution (CIPRO+FLUO), ciprofloxacin 0.3 % otic solution alone (CIPRO), and fluocinolone acetonide 0.025 % otic solution alone (FLUO) administered into the middle ears of pediatric patients with Acute Otitis Media with Tympanostomy Tubes (AOMT). MATERIALS AND METHODS: We performed a PK analysis of patients who participated in two multicenter, randomized, double-blind AOMT clinical trials (SALVAT studies CIFLOTIII/10IA02 and CIFLOTIII/10IA04). Each patient received 0.25 mL of CIPRO+FLUO, CIPRO, or FLUO twice a day instilled into the ear canal(s) for 7 days to treat AOMT. Blood samples of patients with unilateral AOMT were collected before the administration of the first dose of study medication at Visit 1 (day 1) and within 1-2 h after the last dose on day 7. Blood samples were analyzed to detect ciprofloxacin and fluocinolone acetonide concentrations using two validated liquid chromatography-tandem mass spectrometry (LC-MS-MS) methods, with the lower limit of quantification for ciprofloxacin and fluocinolone acetonide in plasma samples being 1 ng/mL. Thirty randomly selected patients between 10 months and 10 years of age (mean age, 4.4 years) were included in the study. Although all available samples were analyzed, only PK data of the 22 patients with both samples and unilateral disease were considered for study purposes. RESULTS: No detectable concentrations of ciprofloxacin or fluocinolone acetonide in plasma were observed (<1 ng/mL). CONCLUSIONS: These results demonstrated negligible systemic exposure to ciprofloxacin and fluocinolone acetonide following topical otic administration in pediatric patients with AOMT.


Assuntos
Ciprofloxacina , Otite Média , Administração Tópica , Criança , Pré-Escolar , Quimioterapia Combinada , Fluocinolona Acetonida/uso terapêutico , Humanos
4.
J Chromatogr A ; 1679: 463380, 2022 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-35970050

RESUMO

An anti-inflammatory skin condition is treated with fluocinolone acetonide (FLA), a synthetic corticoid. The current study aims to develop a stability-indicating UPLC method for the determination of impurities present in fluocinolone acetonide and its topical oil formulation. The method development was performed by implementing Analytical Quality by Design (AQbD) and green chemistry principles. A detailed risk assessment was conducted based on the cause-and-effect relationship. d-optimal split-plot design was employed to screen the critical method parameters (CMPs). The central composite design (CCD) was employed to optimize the final method conditions. p-values for the model and lack of fit were <0.0001 and >0.05, respectively, which indicates the best fit statistical model for the studied responses (peak resolutions R1 - R5). The critical method attributes (CMAs) and CMPs such as the ratio of ACN: Water in mobile phase-B as 600:400 (v/v), the ratio of mobile phase-A & B in initial gradient program as 60:40, flow rate as 0.3 mL min-1, and column oven temperature as 50 °C were optimized from the CCD. The best possible separation among all components was achieved with a gradient elution using Waters Acquity UPLC HSS C18, 100 mm × 2.1 mm, 1.8 µm analytical column. The optimized gradient program is time (min)/%B: 0.0/40, 1.5/40, 6.0/60, 8.0/70, 9.0/80, 12.0/100, 15.0/100, 15.1/40 & 18.0/40. Optimization of diluent is highly critical for any oil-based formulations. The experimental results show that acetonitrile is the most suitable diluent for the current study. The method validation was executed in compliance with ICH and USP 〈1225〉 guidelines. Mean recovery of the impurities ranged between 95.7 and 105.7%, the correlation coefficient(r) was> 0.999, the RSD values (n = 6) ranged between 0.9 - 3.2% across the range for LOQ - 150% levels. The peaks from the specificity study did not interfere with the known and active analyte peaks. The major degradation products were identified as Imp-C, B, and A, and established their degradation pathways from FLA based on the stress studies. The method greenness was evaluated using GAPI, AGREE and analytical eco scale and found that the method is green.


Assuntos
Excipientes , Fluocinolona Acetonida , Cromatografia Líquida de Alta Pressão , Reprodutibilidade dos Testes , Projetos de Pesquisa
5.
J Cosmet Dermatol ; 21(9): 3707-3728, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35854432

RESUMO

Melasma is a common malady affecting all races with a higher incidence in Hispanics, Middle Eastern, Asians, and African origin females (Fitzpatrick skin phototypes III-V). Women are affected much more often than men. Melasma remains a significant cause of cosmetic morbidity and psychosocial embarrassment affecting quality of life necessitating effective and reliable treatment. Unfortunately, treatment remains unsatisfactory due to limited efficacy, adverse effects, and relapses after stopping treatment. Although chemical peels, laser and light therapies and dermabrasion may have utility, the evidence available for their efficacy is limited and they often cause post-inflammatory hyperpigmentation, particularly in individuals with darker skin types. Medical therapies remain mainstay in the management of melasma. The triple combination, hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01% (Triluma, Galderma, Ft. Worth Texas, often modified incorporating different corticosteroids) remains the only US FDA-approved treatment for melasma and is the gold standard due its demonstrated efficacy across ethnicities. Oral tranexamic acid alone or in combination with other modalities has also shown significant efficacy. Several cosmeceuticals and botanical extracts used as skin lightening agents have been demonstrated to be useful. Physical sunscreens containing zinc oxide, iron oxide, titanium dioxide, and silicones provide photoprotective and camouflage effect. We propose that a multimodality approach to the treatment of melasma is the most effective treatment approach. This review is focused on the medical therapies for melasma.


Assuntos
Cosmecêuticos , Melanose , Ácido Tranexâmico , Óxido de Zinco , Corticosteroides , Feminino , Fluocinolona Acetonida , Humanos , Hidroquinonas/uso terapêutico , Masculino , Melanose/etiologia , Melanose/terapia , Qualidade de Vida , Silicones , Protetores Solares , Resultado do Tratamento , Tretinoína/uso terapêutico
6.
JAMA Netw Open ; 5(7): e2221699, 2022 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-35834251

RESUMO

Importance: Ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution seems to be efficacious and safe in treating acute otitis externa (AOE) compared with ciprofloxacin, 0.3%, or fluocinolone acetonide, 0.025%, otic solution alone. Objective: To evaluate the superiority of ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution compared with ciprofloxacin, 0.3%, or fluocinolone acetonide, 0.025%, otic solution alone in treating AOE. Design, Setting, and Participants: A phase 3 randomized, double-blind, active-controlled clinical trial was conducted between August 1, 2017, and September 14, 2018, at 36 centers in the US. The study population comprised 493 patients aged 6 months or older with AOE of less than 21 days' duration with otorrhea, moderate or severe otalgia, and edema, as well as a Brighton grading of II or III (tympanic membrane obscure but without systemic illness). Statistical analysis was performed from November 14, 2018, to February 14, 2019. Interventions: Participants were randomly assigned to receive ciprofloxacin plus fluocinolone, ciprofloxacin, or fluocinolone twice daily for 7 days and were evaluated on day 1 (visit 1; baseline), days 3 to 4 (visit 2; conducted via telephone), days 8 to 10 (visit 3; end of treatment), and days 15 to 17 (visit 4; test of cure). Main Outcomes and Measures: The primary outcome was therapeutic cure (clinical and microbiological) at the end of the treatment period. The principal secondary end point was the time to end of ear pain. Efficacy analyses were conducted in the microbiological intent-to-treat population, clinical intent-to-treat population, and microbiological intent-to-treat population with Pseudomonas aeruginosa and Staphylococcus aureus. Results: A total of 493 patients (254 female patients [51.5%]; mean [SD] age, 38.2 [23.1] years) were randomized (197 to receive ciprofloxacin plus fluocinolone, 196 to receive ciprofloxacin, and 100 to receive fluocinolone). Therapeutic cure in the modified intent-to-treat population with ciprofloxacin plus fluocinolone (63 of 103 [61.2%]) was statistically comparable to that of ciprofloxacin (49 of 91 [53.8%]; difference in response rate, 7.3%; 95% CI, -6.6% to 21.2%; P = .30) and fluocinolone (20 of 45 [44.4%]; difference in response rate, 16.7%; 95% CI, -0.6% to 34.0%; P = .06) at visit 3 and significantly superior to ciprofloxacin at visit 4 (90 of 103 [87.4%] vs 69 of 91 [75.8%]; difference in response rate, 11.6%; 95% CI, 0.7%-22.4%; P = .04). A statistically faster resolution of otalgia was achieved among patients treated with ciprofloxacin plus fluocinolone (median, 5.0 days [range, 4.2-6.3 days]) vs ciprofloxacin (median, 5.9 days [range, 4.3-7.3 days]; 95% CI, 4.3-7.3 days; P = .002) or fluocinolone (median, 7.7 days [range, 6.7-9.0 days]; 95% CI, 6.7-9.0 days; P < .001). Ciprofloxacin plus fluocinolone demonstrated statistical superiority in sustained microbiological response vs ciprofloxacin (94 of 103 [91.3%] vs 74 of 91 [81.3%]; difference in response rate, 9.9%; 95% CI, 0.3%-19.6%; P = .04) and fluocinolone (34 of 45 [75.6%]; difference in response rate, 15.7%; 95% CI, 2.0%-29.4%; P = .01) and in the microbiological outcome vs fluocinolone by visit 3 (99 of 103 [96.1%] vs 37 of 45 [82.2%]; difference in response rate, 13.9%; 95% CI, 2.1%-25.7%; P = .01) and ciprofloxacin by visit 4 (97 of 103 [94.2%] vs 77 of 91 [84.6%]; difference in response rate, 9.6%; 95% CI, 0.9%-18.2%; P = .02). Fifteen adverse events related to study medications were registered, all of which were mild or moderate. Conclusions and Relevance: Ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution was efficacious and safe in treating AOE but did not demonstrate superiority vs ciprofloxacin, 0.3%, or fluocinolone acetonide, 0.025%, otic solutions alone in the main study end point of therapeutic cure. Trial Registration: ClinicalTrials.gov Identifier: NCT03196973.


Assuntos
Otite Externa , Doença Aguda , Administração Tópica , Adulto , Antibacterianos/efeitos adversos , Ciprofloxacina/efeitos adversos , Ciprofloxacina/uso terapêutico , Dor de Orelha/induzido quimicamente , Dor de Orelha/tratamento farmacológico , Feminino , Fluocinolona Acetonida/uso terapêutico , Humanos , Otite Externa/induzido quimicamente , Otite Externa/tratamento farmacológico
8.
AAPS PharmSciTech ; 23(5): 122, 2022 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-35460022

RESUMO

This study introduces fluocinolone acetonide (FA) microemulsion in combination with ablative fractional lasering as a new effective treatment for scalp psoriasis. A pseudo-ternary phase diagram was constructed using the aqueous titration method. The suitable ratio of surfactant mixture (Smix):oil mixture (Omix):water was chosen from the microemulsion region of the diagram. FA was loaded into the selected ratio to prepare FA microemulsion. Ex vivo skin permeation study of the FA microemulsion with fractional laser assistance was performed to determine a proper ablative depth. A pilot clinical study was conducted to evaluate the efficacy of FA microemulsion and FA microemulsion combination with lasering at the optimum ablation depth. The selected microemulsion base contained (in wt%) 77% water, 20% Smix (Tween 80:ethanol, 2:1), 3% Omix (10% benzyl benzoate and 1% benzyl alcohol in bergamot oil), and 0.2% sodium carboxymethylcellulose. FA was loaded into this base at a concentration of 0.1%. The skin lasered at an ablation depth of 50 µm was conducted in the pilot clinical study. Scalp psoriasis responded well to the FA microemulsion. Psoriasis scalp severity index (PSSI) scores indicated that the FA microemulsion plus laser treatment provides higher efficacy than the FA microemulsion alone without any topical and systemic side effects. The efficacy of the treatments could be maintained for at least 1 week after treatment discontinuation. FA microemulsion was properly formulated and evaluated. The microemulsion demonstrating the greatest benefits was used in combination with ablative fractional lasering to treat scalp psoriasis.


Assuntos
Fluocinolona Acetonida , Psoríase , Emulsões , Humanos , Lasers , Psoríase/tratamento farmacológico , Couro Cabeludo , Água
9.
Eur J Ophthalmol ; 32(6): 3629-3636, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-35484812

RESUMO

PURPOSE: To assess the clinical efficacy of the fluocinolone acetonide (FA) intravitreal implant (Iluvien, Alimera Sciences) over a 12-month period in a population resistant to treatment with first-line anti-VEGF agents. METHODS: This study is a retrospective cohort study assessing functional and anatomical outcomes in 13 eyes of 12 patients treated for diabetic macular oedema (DMO) with a single fluocinolone implant (FA) (Iluvien) under real-world conditions. The follow-up period includes the time of first intravitreal treatment (incl anti-VEGF or short-lasting steroids) given until 12 months post FA implant insertion. Primary outcomes were best corrected visual acuity (BCVA), measured using the modified Early Treatment Diabetic Retinopathy Study (ETDRS) grading scale, and central foveal thickness (CFT), measured using Topcon 3DOCT-2000 (Topcon Inc) SD-OCT imaging. Mean BCVA and CFT were measured before anti-VEGF treatment, after anti-VEGF treatment, at the time of Iluvien implant insertion, and 6 and 12 months after Iluvien implant insertion. The t-paired sample test was used to ascertain statistical significance of changes in comparison of two samples while the ANOVA analysis was used in comparison of three or more samples. RESULTS: The baseline BCVA (SD) of the cohort prior to initiation of anti-VEGF treatment was 47.45 (12.27) ETDRS letters whilst the mean CFT (SD) was 579 (203) microns. Following completion of anti-VEGF therapy, the mean improvement in vision was 8.9 ETDRS letters (p = 0.1) whilst the mean reduction in CFT was 197 microns (p = 0.028). Mean BCVA (SD) at the time of insertion of the FA implant was 55.15 (11.16) ETDRS letters and mean (SD) CFT at time of insertion of the FA was 454.62 µm (109.51). Following the 12-month treatment period with the FA implant, BCVA (SD) was 62.15 (10.25) ETDRS letters (p = 0.0331) and the mean (SD) CFT was 404.36 µm (142.92), a change of -50.26 µm from baseline (p = 0.0369). CONCLUSIONS: This study has shown that statistically significant improvements in BCVA and CFT can be achieved over a 12-month period with the Iluvien implant. The implant has been shown to be a safe option in the treatment of DMO and may have a role to play in achieving good functional and anatomical outcomes in DMO while also reducing the frequency of follow-up appointments required to maintain stable vision in the working-age population.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Diabetes Mellitus/tratamento farmacológico , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Implantes de Medicamento/uso terapêutico , Fluocinolona Acetonida , Glucocorticoides , Humanos , Injeções Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Estudos Retrospectivos , Acuidade Visual
10.
J Drugs Dermatol ; 21(3): 321-322, 2022 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-35254752

RESUMO

Oral tranexamic acid (TXA) is a relatively new treatment option for melasma. It is thought to reduce hyperpigmentation through inhibition of the plasminogen/plasmin pathway with resulting decreases in epidermal melanocyte tyrosinase activity, inflammatory mediators, dermal neovascularization, and mast cell numbers.


Assuntos
Hiperpigmentação , Melanose , Ácido Tranexâmico , Fluocinolona Acetonida/análogos & derivados , Humanos , Melanose/diagnóstico , Melanose/tratamento farmacológico , Resultado do Tratamento
11.
Retina ; 42(7): 1392-1398, 2022 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-35321998

RESUMO

PURPOSE: The aim of our prospective off-label, interventional clinical trial was to evaluate the efficacy and safety of the fluocinolone-loop-anchoring technique over two years in eyes with iris-lens diaphragm disruption and pseudophakic cystoid macular edema. METHODS: In 10 eyes, scleral fixation of fluocinolone implant was performed. Main outcome measures were the development of best-corrected visual acuity (BCVA), central retinal thickness over 24 months, and general safety of the procedure. RESULTS: A significant improvement to 0.57 ± 0.38 log MAR (Snellen 20/80) (range 0-1.30) was observed (P = 0.003) at 1 month. Further improvement to 0.45 ± 036 log MAR (Snellen 20/60) was observed until month 18 (P = 0.081). Mean central retinal thickness decreased by 22% from 601.6 ± 235.5 µm to 449.1 ± 128.9 µm at 1 month. In one patient, the implant has to be removed at Month 7 because of elevated intraocular pressure and one patient after globe rupture had a retinal redetachment at Month 4. CONCLUSION: In this study, we showed that the treatment of recalcitrant pseudophakic cystoid macular edema with scleral fixated fluocinolone implant in eyes with disruption of the iris-lens diaphragm provides good anatomical and functional results with a reasonable safety profile over 24 months in eyes where pseudophakic cystoid macular edema is otherwise difficult to treat and often left untreated.


Assuntos
Edema Macular , Fluocinolona Acetonida/análogos & derivados , Humanos , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Estudos Prospectivos , Pirimidinas , Estudos Retrospectivos , Esclera/cirurgia
12.
Graefes Arch Clin Exp Ophthalmol ; 260(8): 2537-2547, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35239010

RESUMO

PURPOSE: To investigate the changes in vitreous inflammatory and angiogenic cytokine levels, primarily interleukin-(IL)-6, following intravitreal injection of the 0.19 mg fluocinolone acetonide (FAc, ILUVIEN®) implant in patients with diabetic macular edema. METHODS: A single-center phase IV study involving 12 patients' eyes with diabetic macular edema. Vitreous fluid samples were obtained prior to intravitreal injection of the fluocinolone acetonide implant and then again over a 6-month period. Vitreous samples were examined using a cytometric bead array to measure IL-6, IL-8, IP-10, MCP-1, VEGF, and CD54. PIGF and PEDF were measured using an enzyme-linked immunosorbent assay. Changes in the cytokine and chemokine expression patterns were analyzed. Clinical parameters such as BCVA and center point thickness (CPT) were also examined. RESULTS: There were mean reductions in all parameters between baseline and month 6. Significant changes (p < 0.05 versus baseline) were observed in the expression of IL-6, IP-10, MCP-1, and CD54 following the administration of fluocinolone acetonide implant. VEGF and PIGF increased at month 1 before declining at month 6, though this trend was not significant. CPT decreased rapidly between screening and the first follow-up visit, and this decrease was sustained. BCVA remained relatively stable throughout. CONCLUSION: This study demonstrated changes in vitreous inflammatory and angiogenic cytokine levels following intravitreal injection of the FAc implant in patients with diabetic macular edema. Data show that the fluocinolone acetonide implant led to rapid and sustained reductions of some inflammatory cytokines with improvement of the overall clinical picture.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Quimiocina CXCL10/uso terapêutico , Citocinas , Retinopatia Diabética/complicações , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Implantes de Medicamento/uso terapêutico , Feminino , Fluocinolona Acetonida , Glucocorticoides , Humanos , Interleucina-6 , Injeções Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Fator de Crescimento Placentário/uso terapêutico , Fator A de Crescimento do Endotélio Vascular , Acuidade Visual
13.
BMC Oral Health ; 22(1): 58, 2022 03 04.
Artigo em Inglês | MEDLINE | ID: mdl-35246095

RESUMO

BACKGROUND: Although topical steroids are an effective treatment for oral lichen planus, they can have suppressive effects on oral immunity and predispose the patients to Candida overgrowth. Lactoferrin is a crucial local immunity protein in the oral cavity with important antimicrobial activity. The aim of this study was to prospectively investigate salivary lactoferrin secretion levels and Candida colonization in oral lichen planus patients treated with fluocinolone acetonide 0.1% in orabase. METHODS: Saliva samples were collected from 15 oral lichen planus subjects who had never received topical steroid treatment prior to this study and 15 healthy volunteers to determine their salivary lactoferrin levels using an enzyme-linked immunosorbent assay and to investigate the presence of oral Candida species at baseline and 3 months after treatment with fluocinolone acetonide 0.1% in orabase. Statistical analysis was performed to compare lactoferrin secretion and Candida colonization levels between the groups using the Mann-Whitney U test for independent data or the Wilcoxon Signed-Rank test for paired data. RESULTS: The salivary lactoferrin secretion level was not significantly different between the control group and oral lichen planus patients or between before and after treatment with fluocinolone acetonide 0.1% in orabase (P > 0.05). Candida was detected in 11 (73.33%) healthy volunteers, 8 (53.33%) oral lichen planus patients before treatment, and 9 (60%) oral lichen planus patients after treatment with fluocinolone acetonide 0.1% in orabase. There was no significant difference in Candida counts between the groups (P > 0.05). CONCLUSION: Our study indicates that using fluocinolone acetonide 0.1% in orabase to treat oral lichen planus for 3 months did not affect salivary lactoferrin protein secretion or Candida carriage. Trial registration The trial was registered at the Thai Clinical Trials Registry (TCTR identifier: TCTR20200723002).


Assuntos
Lactoferrina , Líquen Plano Bucal , Candida , Fluocinolona Acetonida/uso terapêutico , Humanos , Lactoferrina/metabolismo , Lactoferrina/uso terapêutico , Líquen Plano Bucal/tratamento farmacológico , Líquen Plano Bucal/metabolismo , Estudos Prospectivos
14.
Eur J Ophthalmol ; 32(4): 1890-1899, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35139688

RESUMO

Center-involving diabetic macular edema (DME) is a leading cause of vision impairment in working-age adults. While its management is particularly challenging in a poorly compliant population, continuous innovation and the advent of new molecules have improved its outcome. The control of glycemia and of systemic aggravating factors remain essential to slow down progression of disease complications including DME. The indications for macular laser photocoagulation has progressively been phased out as a standard of care and replaced by local intraocular anti-VEGFs biologics and glucocorticoids (GCs). Intravitreal GCs in controlled-release drug delivery systems have allowed to reduce injection frequency and treatment burden. The non biodegradable Fluocinolone Acetonide (FAc) implant allows a long-lasting stabilization of both functional and anatomic improvements. However, adequate patient selection and monitoring through regular follow-up are essential for optimal results. Based on their experience and the latest literature, the aim of the present review is to provide international expert panel consensus on the place of the FAc implant in the treatment algorithm of DME, as well as its safety profile and how to manage it.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Adulto , Algoritmos , Diabetes Mellitus/tratamento farmacológico , Retinopatia Diabética/complicações , Retinopatia Diabética/tratamento farmacológico , Implantes de Medicamento/uso terapêutico , Fluocinolona Acetonida , Glucocorticoides , Humanos , Injeções Intravítreas , Edema Macular/tratamento farmacológico , Edema Macular/etiologia
15.
Ophthalmic Res ; 65(3): 310-320, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35086095

RESUMO

INTRODUCTION: The objective of this study is to compare changes in ganglion cell layer (GCL) between vitrectomized and nonvitrectomized eyes with diabetic macular edema (DME) over a 2-year period following treatment with 0.2 µg/day fluocinolone acetonide (FAc) implant. METHODS: Eighteen vitrectomized (group 1) and 8 nonvitrectomized (group 2) eyes were included in this cohort study. Changes in central macula GCL thickness were measured using the Spectralis spectral domain-optical coherence tomography at baseline and 6, 12, and 24 months of follow-up. Other parameters analyzed included best-corrected visual acuity (BCVA), central foveal thickness (CFT), and intraocular pressure (IOP). RESULTS: Treatment with the FAc implant led to small reductions in mean global GCL thickness versus baseline and contrasts with the control group that was stable or slightly increased versus baseline. FAc therapy also led to improvements in mean BCVA and CFT that were observed at Month 6 and maintained to Month 24. For vitrectomized and nonvitrectomized eyes, no differences were observed between mean global GCL, BCVA, and CFT values during follow-up. Linear correlations revealed that in all groups mean BCVA at Month 24 positively correlated with mean GCL thickness at baseline and at Month 24. IOP remained stable throughout the 24 months. CONCLUSION: There was no evident retinal neurodegeneration in the 2-year period following treatment with FAc in both groups. GCL thickness may be a useful biomarker for assessing safety and effectiveness in patients with DME.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Estudos de Coortes , Retinopatia Diabética/complicações , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Implantes de Medicamento/uso terapêutico , Fluocinolona Acetonida , Glucocorticoides , Humanos , Injeções Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Estudos Retrospectivos , Acuidade Visual
16.
Ophthalmology ; 129(6): 605-613, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35063472

RESUMO

PURPOSE: To assess the long-term safety and efficacy of the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (Iluvien; Alimera Sciences, Inc) in patients with diabetic macular edema (DME). DESIGN: Three-year, phase 4, nonrandomized, open-label observational study. PARTICIPANTS: Patients with DME who previously received corticosteroid treatment without a clinically significant rise in intraocular pressure (IOP; all eyes, n = 202 eyes of 159 patients; 36-month completion, n = 94 eyes). METHODS: A prospective, observational study in which patients received a 0.19-mg FAc intravitreal implant at baseline and then were observed for safety-, visual-, anatomic-, and treatment burden-related outcomes for up to 36 months. MAIN OUTCOME MEASURES: Primary safety outcomes included changes in IOP and interventions to manage IOP elevations. Secondary outcomes included changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), and adjunctive DME treatment frequency RESULTS: At 36 months after FAc implantation, study eyes showed a mean CST change of -60.69 µm (P < 0.0001) and a mean BCVA change of +3.61 letters (P = 0.0222) compared with baseline. Overall median treatment frequency decreased from 3.4 treatments/year in the 36 months before FAc implantation to 1 treatment/year in the 36 months after FAc implant, a treatment burden reduction of 70.5%. Furthermore, among the group that completed 36 months of treatment (n = 94 eyes), 25.53% of eyes remained rescue free through 36 months. Mean IOP remained stable throughout the study, and IOP increases to more than 30 mmHg occurred in 10.89% of eyes. Intraocular pressure-related procedures were infrequent, with a surgical rate of 2.97%, with 1.49% attributable to steroid use (vs. surgeries attributable primarily to neovascular glaucoma). In addition, an IOP response of < 25 mmHg after the steroid challenge predicted that 96.92% of eyes would have a similar outcome to 0.19-mg FAc implant at the last visit. Intraocular pressure increases that did occur were manageable with standard treatments (n = 202 eyes). CONCLUSIONS: In patients with DME, the 0.19-mg FAc implant provided improved visual outcomes and reduced treatment burden compared with previous treatments while maintaining a favorable safety profile.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Retinopatia Diabética/complicações , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Implantes de Medicamento/uso terapêutico , Fluocinolona Acetonida , Glucocorticoides/uso terapêutico , Humanos , Injeções Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Estudos Prospectivos , Esteroides/uso terapêutico , Acuidade Visual
17.
Retin Cases Brief Rep ; 16(1): 67-69, 2022 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-31339874

RESUMO

BACKGROUND/PURPOSE: To describe management of anterior migration of a fluocinolone acetonide(FAc) intravitreal implant. METHODS: A retrospective case report. A 61-year-old man with diabetic macular edema and prior vitrectomy had anterior migration of a FAc implant. Anterior segment photos and optical coherence tomography were performed. RESULTS: Approximately 3 months after FAc implant was administered, it was noted to have migrated into the anterior chamber. Vision, intraocular pressure, and optical coherence tomography imaging initially remained stable, and no evidence of detectable corneal edema developed in 30 months of follow-up. However, at 36 months of follow-up, after second FAc implant injection, mild corneal edema developed,suspected to be related to the migrating implants. CONCLUSION: Anterior migration of a FAc implant may lead to less rapid and severe corneal decompensation compared with other steroid implants. Despite this, delayed corneal edema may occur. Careful monitoring of the cornea and intraocular pressure is recommended in cases of anterior FAc migration.


Assuntos
Fluocinolona Acetonida , Migração de Corpo Estranho , Retinopatia Diabética/tratamento farmacológico , Implantes de Medicamento , Migração de Corpo Estranho/terapia , Humanos , Edema Macular/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
18.
Retin Cases Brief Rep ; 16(1): 56-58, 2022 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-31688672

RESUMO

PURPOSE: To report the persistence of choroidal lesions despite fluocinolone acetonide intravitreal implants and their resolution with oral prednisone treatment. METHODS: Retrospective chart review of a birdshot chorioretinopathy patient at a tertiary referral clinic. RESULTS: Indocyanine angiography revealed resolution of choroidal lesions with oral prednisone and recurrence after discontinuation of oral prednisone. CONCLUSION: Choroidal lesions responded to oral prednisone despite bilateral active fluocinolone acetonide intravitreal implant in a birdshot chorioretinopathy patient.


Assuntos
Coriorretinopatia de Birdshot , Fluocinolona Acetonida , Coriorretinopatia de Birdshot/tratamento farmacológico , Implantes de Medicamento , Fluocinolona Acetonida/uso terapêutico , Humanos , Estudos Retrospectivos , Falha de Tratamento
19.
Br J Ophthalmol ; 106(2): 234-240, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-33243833

RESUMO

PURPOSE: To report treatment outcomes and efficacy of the fluocinolone acetonide 0.19 mg intravitreal implant (Iluvien) in controlling retinal and choroidal inflammation in 11 patients with birdshot retinochoroiditis. METHODS: A single-centre, retrospective, interventional case series. The primary efficacy end point was improvement in vascular leakage on fluorescein angiography (FA), effect on cystoid macular oedema (CMO) and resolution of hypofluorescent lesions on indocyanine green angiography (ICGA); secondary measures were improvements on pattern and full-field electroretinogram (PERG; ERG) parameters. Safety outcome measures were intraocular elevation and cataractogenesis. RESULTS: Fifteen eyes received Iluvien implant with an average follow-up of 31 months (range 12-36 months). Prior to the implant, 5 (33.3%) eyes had received dexamethasone intravitreal implant 0.7 mg (Ozurdex). FA showed evidence of vascular leakage in all eyes at baseline. Between month 6 and 12, FA showed that 73.4% of eyes had no leakage, this increased to 84.6% by month 24. Three eyes in our study had CMO at baseline. 6 months after Iluvien implant, all eyes achieved complete CMO resolution. One year after insertion of the implant, the characteristic hypofluorescent lesions on ICGA were unchanged in all cases. There was baseline ERG evidence indicating a high incidence of peripheral cone system dysfunction and most showed PERG evidence of macular dysfunction. Retinal function improved and macular function improved or was stable in the majority following treatment. CONCLUSIONS: The results show the possible therapeutic effect of Iluvien in the management of Birdshot-related vascular leakage, CMO and retinal dysfunction. However, choroidal lesions seem to persist with no detectable response to treatment.


Assuntos
Retinopatia Diabética , Edema Macular , Coriorretinopatia de Birdshot , Retinopatia Diabética/complicações , Implantes de Medicamento , Fluocinolona Acetonida , Glucocorticoides/uso terapêutico , Humanos , Injeções Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Estudos Retrospectivos , Acuidade Visual
20.
Retin Cases Brief Rep ; 16(4): 461-465, 2022 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-32649362

RESUMO

BACKGROUND/PURPOSE: To report a case of bilateral diffuse uveal melanocytic proliferation (BDUMP) treated with intravitreal steroid implants. METHOD: Bilateral diffuse uveal melanocytic proliferation was diagnosed and treated with intravitreal steroid implants (both dexamethasone 0.7 mg [intravitreal dexamethasone implants] and fluocinolone acetonide 0.18 mg [intravitreal fluocinolone acetonide implants]) and monitored every 2 weeks to 4 weeks with optical coherence tomography. RESULTS: Intravitreal dexamethasone implants improved visual acuity and central retinal thickness for 10 weeks, was best from 4 to 6 weeks, and recurred by 14 weeks after treatment. Intravitreal fluocinolone acetonide implants improved visual acuity and central retinal thickness for 20 weeks after treatment without edema recurrence. No retinal detachments were observed over 1 year of treatment. CONCLUSION: Intravitreal steroid implants resulted in visual acuity improvement and central retinal thickness reduction for up to 20 weeks and may protect against retinal detachments in patients with bilateral diffuse uveal melanocytic proliferation.


Assuntos
Fluocinolona Acetonida , Neoplasias da Retina , Proliferação de Células , Dexametasona , Implantes de Medicamento , Glucocorticoides/efeitos adversos , Humanos , Injeções Intravítreas , Tomografia de Coerência Óptica , Acuidade Visual
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