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1.
Sci Rep ; 14(1): 4690, 2024 02 26.
Artigo em Inglês | MEDLINE | ID: mdl-38409191

RESUMO

This study investigates the impact of glycosylated hemoglobin (HbA1c) on the efficacy of intravitreal dexamethasone (DEX) implants in patients with diabetic macular edema (DME) over a 12-month period. We retrospectively reviewed 90 DME patients treated with DEX implants, categorizing them based on baseline HbA1c levels (≤ 7% and > 7%) and 12-month changes in HbA1c ("improved", "stable", "worsened"). At the 2-month mark, the mean central subfield thickness (CST) reduction in the HbA1c ≤ 7% group was - 147.22 ± 113.79 µm compared to -130.41 ± 124.50 µm in the > 7% group (p = 0.506). Notably, 12-month outcomes between these groups showed no significant difference. The "improved" HbA1c subgroup experienced a more pronounced CST reduction at 2 months (p = 0.042), with outcomes leveling off with other groups by 12 months. Conclusively, DEX implant outcomes in DME were not influenced by either baseline HbA1c levels or their changes over time. This suggests that local alterations in the inflammation milieu may have a potentially stronger impact on DME treatment outcomes, highlighting the importance of considering local factors in DME treatment.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Edema Macular/tratamento farmacológico , Glucocorticoides/uso terapêutico , Dexametasona/uso terapêutico , Hemoglobinas Glicadas , Inibidores da Angiogênese/uso terapêutico , Estudos Retrospectivos , Implantes de Medicamento/uso terapêutico , Resultado do Tratamento , Injeções Intravítreas , Diabetes Mellitus/induzido quimicamente
2.
Expert Opin Drug Saf ; 23(2): 199-205, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38234187

RESUMO

BACKGROUND AND OBJECTIVE: Intravitreal dexamethasone implant (DEXI) has been placed as an effective option to treat diabetic macular edema (DME). However, there is no consensus on the best time to introduce it. We conducted a study to evaluate anatomical and functional behavior after the first DEXI according to previous treatment. RESEARCH DESIGN AND METHODS: This retrospective, real-world study between 2013 and 2020 investigated changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT at months 2 and 6 after the first DEXI in DME. Patients were divided into naive, early switch (≤3 anti-VEGF injections), or late switch (>3 anti-VEGF injections) groups. RESULTS: Among 112 consecutive eyes, mean BCVA and CMT improved significantly in all groups at month 2, with no difference between them. However, this improvement was not maintained at 6 months. The Naíve group presented better BCVA all over the study period. The previously treated groups, which started with worse initial visual acuity, showed more visual gain without reaching the BCVA of the naive group. CMT performance was similar between groups. CONCLUSIONS: There was similar anatomical and functional behavior in all groups. Poorer visual acuity at baseline was associated with worse functional outcome despite good anatomic response.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Dexametasona , Edema Macular/tratamento farmacológico , Retinopatia Diabética/tratamento farmacológico , Estudos Retrospectivos , Implantes de Medicamento/uso terapêutico , Injeções Intravítreas , Protocolos Clínicos , Glucocorticoides , Resultado do Tratamento , Inibidores da Angiogênese
3.
Semin Ophthalmol ; 39(3): 242-248, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38282256

RESUMO

PURPOSE: To compare the outcomes of early or late switching from intravitreal (IV) anti-vascular endothelial growth factor (anti-VEGF) injection to IV Dexamethasone (DEX) implant injection in treatment-naïve patients with macular edema secondary to branch retinal vein occlusion. METHODS: This study included 68 eyes of 68 treatment-naïve BRVO patients who started anti-VEGF treatment. After the loading dose, the patients were divided into two groups: Early DEX group (n:34) (DEX implant treatment started after 3 loading doses) and Late DEX group (n:34) (DEX implant treatment started after 6 months). Visual acuity and examination findings were recorded at baseline, 3rd, 6th, and 12th month follow-ups. Optical coherence tomography data were recorded for central macular subfield thickness assessment. RESULTS: A total of 30 (44.1%) women and 38 (55.9%) men participated, and the average age was 67.6 ± 6.4 years. The mean letter gains at week 52 was 15.1 and 20.9 in the Early DEX and Late DEX groups, respectively. The group with the highest gain of ≥15 letters was the Late DEX group (26/34 patients) and the gain of ≥15 letters was 14/34 in the Early DEX group (p: 0.006). At week 52, the anatomical gain was 115.3 µm and 136.9 µm in the Early DEX and Late DEX groups, respectively. CONCLUSIONS: A gain of 15 or more letters was demonstrated to be higher in patients who switched to DEX implant late after anti-VEGF treatment. If it is necessary to switch, the late switch may be more effective for more visual gain at the end of the first year.


Assuntos
Edema Macular , Oclusão da Veia Retiniana , Masculino , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Glucocorticoides/uso terapêutico , Dexametasona , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Oclusão da Veia Retiniana/complicações , Oclusão da Veia Retiniana/diagnóstico , Oclusão da Veia Retiniana/tratamento farmacológico , Resultado do Tratamento , Estudos Retrospectivos , Injeções Intravítreas , Implantes de Medicamento/uso terapêutico
5.
Eur J Ophthalmol ; 34(1): NP90-NP95, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37350018

RESUMO

INTRODUCTION: We describe a case of acute exudative polymorphous vitelliform maculopathy (AEPVM) that recurred 9 years after the initial event. To the best of our knowledge, this is the first report of recurrent AEPVM showing recovery of retinal and retinal pigment epithelium (RPE) function and good visual outcome following treatment with intravitreal corticosteroid. CASE DESCRIPTION: A 45-year-old Caucasian woman first presented with AEVPM in 2009. Her condition spontaneously resolved and she remained stable over several years. 9 years later, her condition recurred with bilateral reduction in visual acuity. Fundus examination revealed multiple small yellowish subretinal lesions across the posterior pole in both eyes. Optical coherence tomography (OCT) showed bilateral cystoid macular oedema (CMO). She was referred for electrophysiology and her electrooculogram findings were in keeping with severe generalised RPE dysfunction bilaterally, with a light peak to dark trough ratio (Arden index) of 110%, comparable to her initial presentation 9 years earlier. She was initially treated with oral steroids with some improvement. However, the maculopathy in the left eye recurred on cessation of oral treatment. A sustained-release 700ug dexamethasone intravitreal implant (Ozurdex®) was inserted in the left eye to which she responded remarkably, with improvement in visual acuity and complete resolution of the CMO. A year later, at her most recent clinic visit in March 2021, there was no evidence of any further recurrence. CONCLUSION: Our case demonstrates clinical and imaging findings consistent with recurrence of AEPVM with CMO that has been successfully treated with Ozurdex®.


Assuntos
Edema Macular , Doenças Retinianas , Distrofia Macular Viteliforme , Humanos , Feminino , Pessoa de Meia-Idade , Distrofia Macular Viteliforme/diagnóstico , Distrofia Macular Viteliforme/tratamento farmacológico , Dexametasona , Doenças Retinianas/diagnóstico , Epitélio Pigmentado da Retina , Tomografia de Coerência Óptica , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Injeções Intravítreas , Implantes de Medicamento/uso terapêutico
6.
Eur J Ophthalmol ; 34(1): 233-244, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37475207

RESUMO

INTRODUCTION: A detailed understanding of the anatomical and structural changes occurring in the retina following intravitreal fluocinolone acetonide implantation may help improve the management and prognosis of persistent or recurrent diabetic macular edema (DME). METHODS: Overall, 45 eyes (from 35 patients) with refractory center-involved DME received an intravitreal fluocinolone acetonide implant. They were monitored at baseline and at 6, 12, 24, and 36 months for best-corrected visual acuity (BCVA), central foveal thickness (CFT), and the seven retinal parameters used in the classification of diabetic maculopathy recently developed at the European School for Advanced Studies in Ophthalmology (ESASO). RESULTS: Within 6 months of implantation, significant improvements were evident in BCVA, CFT, maculopathy stage, and the percentage of eyes with: intraretinal cysts; CFT > 30% above the upper normal value; and disrupted or absent ellipsoid zone (EZ) and/or external limiting membrane (ELM). Significant improvements were still maintained at 36 months post-implantation. At month 36, early treatment with the implant (i.e., after < 6 previous intravitreal injections for DME) trended toward being more effective than later treatment in improving BCVA, CFT, maculopathy stage, and the percentage of eyes with CFT > 30% above the upper normal value. However, statistical significance was not achieved. CONCLUSION: In persistent or recurrent DME, fluocinolone acetonide implantation can be effective in improving maculopathy stage and reducing the percentage of eyes with: intraretinal cysts; CFT > 30% above the upper normal value; and disrupted or absent EZ and/or ELM. It can also increase BCVA and reduce CFT.


Assuntos
Cistos , Retinopatia Diabética , Edema Macular , Oftalmologia , Humanos , Fluocinolona Acetonida , Retinopatia Diabética/tratamento farmacológico , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Tomografia de Coerência Óptica , Retina , Injeções Intravítreas , Implantes de Medicamento/uso terapêutico , Estudos Retrospectivos
7.
Int Ophthalmol ; 43(12): 4639-4649, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37697082

RESUMO

OBJECTIVE: To assess the effectiveness and safety of the intravitreal fluocinolone-acetonide implant (FAc-i) in patients with chronic diabetic macular edema who did not sufficiently respond to other available therapies. METHODS: This was a multicenter, prospective, non-randomized, and phase-IV observational study conducted on patients with recurrent-DME who were insufficient responders to currently available therapies (REACT-Study). The primary end-point was the mean change in best-corrected-visual-acuity from baseline to month-24 values. RESULTS: Thirty-one eyes from 31 patients were included in the study. Mean age was 68.0 ± 7.7 years, and 10 (32.3%) were women. Study patients had received 5.3 ± 7.3 previous DME treatments before starting the study. In the overall study sample, BCVA improved from 56.1 ± 12.3 letters at baseline to 62.4 ± 17.0 letters at month-24 (p = 0.0510). The eyes with a baseline BCVA < 70 ETDRS letters had a significant improvement in BCVA from 53.2 ± 10.2 letters at baseline to 61.5 ± 17.9 letters at month-24 (p = 0.0165). In the overall study population, central-subfoveal-thickness (CST) was significantly reduced from 474.0 ± 135.1 µm at baseline to 333.4 ± 135.6 at month-24 (p < 0.0001). Similarly, macular-volume (MV) was significantly reduced from 10.7 ± 2.7 mm3 at baseline to 9.6 ± 2.9 mm3 (p = 0.0027) at month-24. Among the 31 study eyes, 19 (61.3%) required an additional treatment for DME. Throughout the study, 9 (29.0%) eyes required ocular hypotensive medication for controlling their intraocular-pressure and 5 (16.1%) eyes underwent cataract surgery. CONCLUSIONS: In DME eyes who did not sufficiently respond to previous therapies, the FAc-i was associated with an improvement in visual and anatomic outcomes. There were no unexpected adverse-events. TRIAL REGISTRATION NUMBER: EudraCT identifier: 2016-001680-37.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Masculino , Glucocorticoides/uso terapêutico , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Retinopatia Diabética/complicações , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Estudos Prospectivos , Fluocinolona Acetonida/uso terapêutico , Implantes de Medicamento/uso terapêutico , Injeções Intravítreas
8.
BMJ Open Ophthalmol ; 8(1)2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37541745

RESUMO

AIM: To evaluate effectiveness of dexamethasone intravitreal implant 0.7 mg (DEX) monotherapy in the AUSSIEDEX study non-responder subgroup, defined by diabetic macular oedema (DME) refractory to anti-vascular endothelial growth factor (anti-VEGF) agents. METHODS: This prospective, open-label, observational, real-world study included pseudophakic and phakic (scheduled for cataract surgery) eyes that did not achieve a ≥5-letter best corrected visual acuity (BCVA) gain and/or clinically significant central subfield retinal thickness (CRT) improvement after 3-6 anti-VEGF injections for DME (N=143 eyes), regardless of baseline BCVA and CRT. After an initial DEX injection (baseline visit), reinjection was permitted at ≥16-week intervals. PRIMARY ENDPOINTS: changes in mean BCVA and CRT from baseline to week 52. Safety assessments included adverse events. RESULTS: Of 143 eyes, 53 (37.1%) and 89 (62.2%) switched to DEX after 3-6 (early) and >6 (late) anti-VEGF injections, respectively; 1 (0.7%) had missing information. With 2.3 injections (mean) over 52 weeks, the change in mean BCVA from a baseline of 57.8 letters was not significant at week 52. Mean CRT improved significantly from a baseline of 417.8 µm at week 52 (mean change -60.9 µm; p<0.001). Outcomes were similar in eyes switched to DEX early and late. No unexpected adverse events were reported; no filtration surgeries were required. CONCLUSION: To date, AUSSIEDEX is the largest prospective, real-world study of DEX monotherapy for treatment-naïve or anti-VEGF-refractory DME. Following early or late switch from anti-VEGF agents, DEX significantly improved anatomic outcomes at 52 weeks without new safety concerns, supporting use in anti-VEGF-refractory DME. TRIAL REGISTRATION NUMBER: NCT02731911.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Edema Macular/tratamento farmacológico , Glucocorticoides/efeitos adversos , Dexametasona/efeitos adversos , Estudos Prospectivos , Fator A de Crescimento do Endotélio Vascular/uso terapêutico , Implantes de Medicamento/uso terapêutico , Injeções Intravítreas , Retinopatia Diabética/complicações , Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Diabetes Mellitus/induzido quimicamente
9.
Ophthalmologica ; 246(3-4): 238-244, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37552956

RESUMO

INTRODUCTION: The aim of this study was to evaluate the outcomes and complications associated with the use of same-day bilateral intravitreal dexamethasone (DEX) implants for the treatment of diabetic macular edema (DME). METHODS: This retrospective analysis of an open-label, multicenter, consecutive case series included 130 eyes of 65 patients with bilateral DME who were treated with intravitreal DEX implants. The patients were divided into two groups: a control group (comprising 40 eyes treated with an alternating unilateral regimen) and a study group (comprising 90 eyes treated with concomitant bilateral DEX implants). All patients were followed up monthly after implantation. The changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to sixth month after implantation, and ocular adverse effects such as intraocular pressure, cataract, and tolerability of bilateral implantation were reviewed. The primary endpoint was to assess the safety of the same-day bilateral treatment protocol. The secondary endpoints focused on evaluating the functional and anatomical changes associated with bilateral simultaneous or alternating implantations. RESULTS: At 6 months after implantation, mean BCVA increased and CRT decreased in both groups. Moreover, no serious ocular adverse effects were observed. In addition, no differences were observed between the two groups in the number of patients who required extra follow-up visits or the number of extra visits made in addition to the treatment schedule. CONCLUSIONS: Same-day bilateral intravitreal DEX implants are associated with a low complication rate and are well tolerated by patients. This safe practice may optimize efficiency and reduce the burden on both the health-care system and patients, when used to treat bilateral DME.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Dexametasona , Diabetes Mellitus/induzido quimicamente , Diabetes Mellitus/tratamento farmacológico , Retinopatia Diabética/complicações , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Implantes de Medicamento/uso terapêutico , Glucocorticoides , Injeções Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Estudos Retrospectivos , Resultado do Tratamento
10.
J Ocul Pharmacol Ther ; 39(7): 449-455, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37384926

RESUMO

Purpose: This study investigated the impact of baseline clinical and optical coherence tomography (OCT) factors on the response to a 0.19-mg fluocinolone acetonide (FAc) implant in patients with noninfectious uveitic macular edema evaluated by the area under the curve over 24 months. Methods: A retrospective study was conducted of eyes of patients with noninfectious uveitic macular edema undergoing FAc treatment, with follow-up from baseline to 24 months. The area under the curve (AUC) of best-corrected visual acuity (BCVA) and the central macular thickness (CMT) were calculated using the trapezoidal rule. Clinical and OCT data at the time of FAc administration were collected, and associations with AUC of BCVA and CMT changes were investigated. Results: Twenty-three patients were enrolled. BCVA and CMT significantly improved after FAc implantation (P < 0.05). AUCBCVA and AUCCMT were 0.41 ± 0.33 logarithm of minimal angle of resolution/6 months and 320.15 ± 321.64 µm/6 months, respectively. Better baseline BCVA (coefficient [coef.] = 0.83, P < 0.001) and macular thickness reduction after FAc administration (coef. = -0.0001, P < 0.05) were associated with better BCVA after FAc treatment. In contrast, baseline OCT biomarkers such as ellipsoid zone reflectivity and choroidal vascularity index, sex, or disease duration before FAc injection showed no correlation with AUCBCVA and AUCCMT (P > 0.05). The younger the patient at the time of FAc injection, the greater the reduction in CMT (coef. = 1.76, P < 0.05). Conclusions: Among all clinical and morphological baseline factors, Baseline BCVA was the strongest predictor for AUCBCVA, while no association with baseline OCT features was observed. Overall, improvement of BCVA and CMT after FAc injection was maintained over 24 months. This study is registered in the German Clinical Trials Register under the DRKS-ID: DRKS00024399.


Assuntos
Retinopatia Diabética , Edema Macular , Uveíte , Humanos , Glucocorticoides/uso terapêutico , Edema Macular/tratamento farmacológico , Estudos Retrospectivos , Acuidade Visual , Fluocinolona Acetonida/uso terapêutico , Uveíte/tratamento farmacológico , Injeções Intravítreas , Tomografia de Coerência Óptica , Implantes de Medicamento/uso terapêutico , Retinopatia Diabética/tratamento farmacológico
11.
Zhonghua Yan Ke Za Zhi ; 59(5): 398-403, 2023 May 11.
Artigo em Chinês | MEDLINE | ID: mdl-37151009

RESUMO

Objective: To evaluate the effectiveness and safety of intravitreal dexamethasone implant (IDI) in diabetic macular edema (DME) patients with and without prior vitrectomy. Methods: A retrospective cohort study was conducted on DME patients who received IDI treatment at the Aier Eye Hospital, Beijing from March 2018 to August 2020. Patients were divided into two groups according to whether they had undergone vitrectomy or not. Clinical and follow-up data, including best-corrected visual acuity (BCVA), intraocular pressure (IOP), central macular thickness (CMT), occurrence of ocular and systemic complications, and time to DME recurrence and retreatment, were collected before and after IDI injection at 15 days, 1, 2, 3, and 6 months. Statistical analyses were performed using t-test, Mann-Whitney U-test, χ2 test or Fisher's exact test, and generalized estimating equations. Results: Thirty-six patients (41 eyes) were included, with 19 patients (21 eyes) in the vitrectomy group and 17 patients (20 eyes) in the non-vitrectomy group. Compared with baseline, BCVA of eyes in the vitrectomy group was significantly improved at 15 days after IDI injection, with values of 1.00 (0.52, 1.31) and 0.61 (0.30, 1.00), respectively (Z=-2.10, P=0.036); BCVA of eyes in the non-vitrectomy group was significantly improved at 1 month after IDI injection, with values of 0.76 (0.60, 1.35) and 0.52 (0.10, 0.70), respectively (Z=-2.24, P=0.025). Compared with baseline, CMT of eyes in both groups was significantly reduced at all follow-up time points after 15 days of IDI injection (all P<0.05). In the vitrectomy group, CMT before and 15 days after injection were 487 (438, 661) µm and 389 (340, 553) µm, respectively (Z=-3.45, P<0.001); in the non-vitrectomy group, CMT before and 15 days after injection were 486 (410, 641) µm and 323 (290, 396) µm, respectively (Z=-4.07, P<0.001). There were no statistically significant differences in BCVA and CMT between the two groups at all follow-up time points (all P>0.05). The time to DME recurrence was 3.0 (3.0, 4.0) months in the vitrectomy group and 5.0 (4.0, 5.0) months in the non-vitrectomy group, with no significant difference between the two groups (P=0.675). Four eyes (19.0%) in the vitrectomy group and three eyes (15.0%) in the non-vitrectomy group had high IOP, with no significant difference (P=0.529). No severe ocular or systemic complications were observed in any patients. Conclusions: IDI treatment is safe and effective in DME patients with and without prior vitrectomy, with similar efficacy, but with faster onset of action in patients with prior vitrectomy. There was no significant difference in DME recurrence within 6 months after IDI injection between the two groups.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Glucocorticoides/uso terapêutico , Dexametasona/uso terapêutico , Retinopatia Diabética/tratamento farmacológico , Estudos Retrospectivos , Implantes de Medicamento/uso terapêutico , Injeções Intravítreas , Diabetes Mellitus/tratamento farmacológico
12.
Drug Des Devel Ther ; 17: 961-975, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37020801

RESUMO

Fluocinolone acetonide (FAc) intravitreal implant (Iluvien®) is a corticosteroid implant indicated for the treatment of diabetic macular oedema (DMO) in patients who have previously received conventional treatment without good response, non-infectious posterior uveitis, and as an off-label treatment of the macular oedema secondary to retinal vein occlusion. FAc is a non-biodegradable 0.19 mg intravitreal implant which is designed to release FAc over 3 years at a rate of approximately 0.2 mcg per day. The aim of this review is to describe the special pharmacological properties of Iluvien and display the outcomes of the most important clinical trials and real-world studies regarding its efficacy and safety for the management of the above retinal disorders.


Assuntos
Retinopatia Diabética , Fluocinolona Acetonida , Edema Macular , Doenças Retinianas , Humanos , Retinopatia Diabética/tratamento farmacológico , Implantes de Medicamento/uso terapêutico , Fluocinolona Acetonida/administração & dosagem , Fluocinolona Acetonida/farmacologia , Fluocinolona Acetonida/uso terapêutico , Glucocorticoides/uso terapêutico , Injeções Intravítreas , Edema Macular/tratamento farmacológico , Doenças Retinianas/tratamento farmacológico , Anti-Inflamatórios/farmacologia , Anti-Inflamatórios/uso terapêutico
13.
Artigo em Inglês | MEDLINE | ID: mdl-37107744

RESUMO

PURPOSE: To compare the direct costs associated with the dexamethasone intravitreal implant (DEX-i) in treatment-naïve and previously treated eyes with diabetic macular edema (DME) in a real clinical setting. METHODS: Retrospective and single-center study conducted in a real clinical scenario. Consecutive DME patients, either naïve or previously treated with vascular endothelial growth factor inhibitors (anti-VEGF), who received treatment with one or more DEX-i between May 2015 and December 2020, and who were followed-up for a minimum of 12 months, were included in the study. The cost analysis was performed from the perspective of the Andalusian Regional Healthcare Service. The primary effectiveness endpoint was the probability of achieving an improvement in best-corrected visual acuity (BCVA) ≥ 15 ETDRS letters after 1 year of treatment. The incremental cost-effectiveness ratio (ICER) of different improvements in BCVA was calculated. RESULTS: Forty-nine eyes, twenty-eight (57.1%) eyes from the treatment-naïve group and twenty-one (42.9%) from the previously treated group, were included in the analysis. The total cost of one year of treatment was significantly lower in the treatment-naïve eyes than in the previously treated eyes [Hodges-Lehmann median difference: EUR 819.1; 95% confidence interval (CI): EUR 786.9 to EUR 1572.8; p < 0.0001]. The probability of achieving a BCVA improvement of ≥15 letters at month 12 was significantly greater in the treatment-naïve group than in the previously treated group (rate difference: 0.321; 95% CI: 0.066 to 0.709; p = 0.0272). The Cochran-Mantel-Haenszel Odds Ratio of achieving a BCVA improvement of ≥15 letters at month 12 was 3.55 (95% CI: 1.09 to 11.58; p = 0.0309). In terms of ICER, the treatment-naïve group showed cost savings of EUR 7704.2 and EUR 5994.2 for achieving an improvement in BCVA ≥ 15 letters at month 12 and at any of the measured time points, respectively. CONCLUSIONS: DEX-i was found to be more cost-effective in treatment-naïve eyes than in those previously treated with anti-VEGF. Further studies are needed to determine the most cost-effective treatment based on patient profile.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Edema Macular/tratamento farmacológico , Edema Macular/complicações , Retinopatia Diabética/tratamento farmacológico , Glucocorticoides/uso terapêutico , Dexametasona/uso terapêutico , Análise Custo-Benefício , Fator A de Crescimento do Endotélio Vascular , Estudos Retrospectivos , Implantes de Medicamento/uso terapêutico , Resultado do Tratamento , Diabetes Mellitus/tratamento farmacológico
14.
Eur Rev Med Pharmacol Sci ; 27(5): 1743-1758, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36930471

RESUMO

Uveitis is a type of ocular inflammatory disease caused by various etiologies, for which corticosteroids are the main treatment. Dexamethasone Intravitreal implant (DEX-I) has been widely used in the treatment of uveitis across the world. Then, new indications and complications appeared. This review aims to summarize the use of DEX-I in uveitis in the past 10 years. We summarized the clinical data (baseline characteristics, efficacy and safety) and discussed controversies by retrospectively analyzing the articles and cases published in PubMed and Web of Science using the terms "Ozurdex", OR "intravitreal dexamethasone implant", AND "uveitis" from 2010 to 2022. DEX-I is effective in reducing edema, improving inflammation and improving vision when treating various conditions of uveitis including infectious, no-infectious, pediatric uveitis, and surgery-related applications. The efficacy of DEX-I as a monotherapy is related to the following: etiology and course of disease, treatment of systemic diseases, patients' toleration after multiple injections, economic situation, etc. In addition, intravitreal corticosteroids implantation may replace systemic therapy in some patients. In terms of safety, the incidence of high intraocular pressure is about 20.52%, and the incidence of cataract is about 15.51%. DEX-I can effectively treat non-infectious uveitis and some infectious uveitis such as suspected tuberculosis, and its safety is controllable. Further studies are necessary to evaluate the effect of monotherapy and to expand more indications.


Assuntos
Edema Macular , Uveíte , Humanos , Criança , Glucocorticoides/uso terapêutico , Estudos Retrospectivos , Resultado do Tratamento , Edema Macular/tratamento farmacológico , Acuidade Visual , Injeções Intravítreas , Dexametasona/uso terapêutico , Uveíte/tratamento farmacológico , Uveíte/complicações , Implantes de Medicamento/uso terapêutico
15.
Eur Rev Med Pharmacol Sci ; 27(5): 1759-1766, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36930491

RESUMO

OBJECTIVE: Fluocinolone acetonide is a valid alternative treatment for patients with chronic diabetic macular edema (DME) with poor response to anti-vascular endothelial growth factor (VEGF) therapy. The purpose of this study is to report the efficacy and safety of ILUVIEN® implant in pseudophakic eyes with persistent DME. PATIENTS AND METHODS: This is a single-centre pilot-study of 8 patients with persistent DME treated with the ILUVIEN implant, despite previous anti-vascular endothelial growth factor and/or steroid treatment. Best-corrected visual acuity (BCVA), optical coherence tomography (OCT) central retinal thickness, intraocular pressure (IOP) and microperimetric data were evaluated at baseline and month 1, 3 and 6 post treatment. RESULTS: All data are presented as mean and standard deviation. At baseline, 1, 3 and 6 months, we had BCVA of 0.26±0.22, 0.38±0.27, 0.48±0.27 and 0.46±0.24; IOP of 15.00±2.67, 15.50±3.16, 14.88±2.42 and 15.63±2.67 mmHg; macular thickness of 652±231, 487±278, 475±287 and 413±211 µm; macular sensitivity of 6.83±4.20, 6.13±3.72, 7.68±3.40 and 7.71±3.33 dB; bivariate contour elliptic area (BCEA) 95.4% 3.8±3.42, 6.06±10.06, 3.05±2.46 and 2.59±2.19°2. CONCLUSIONS: According to the results of our study, fluocinolone acetonide (FAc) is a valid therapy option despite some limitations. It has been evidenced that FAc is more effective in patients with mild central macular thickening, while in those with modest to severe central macular thickness (CMT), different therapy strategies should be considered.


Assuntos
Retinopatia Diabética , Edema Macular , Humanos , Fluocinolona Acetonida/uso terapêutico , Glucocorticoides/uso terapêutico , Retinopatia Diabética/tratamento farmacológico , Tomografia de Coerência Óptica , Fatores de Crescimento Endotelial/uso terapêutico , Projetos Piloto , Testes de Campo Visual , Edema Macular/tratamento farmacológico , Injeções Intravítreas , Implantes de Medicamento/uso terapêutico
16.
Eur J Ophthalmol ; 33(5): 1903-1910, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36919243

RESUMO

BACKGROUND/OBJECTIVES: To describe the visual and clinical outcomes of patients with post endothelial keratoplasty (EK) cystoid macular oedema (CMO) refractory to topical treatment with intravitreal sustained-release dexamethasone implant (Ozurdex). SUBJECTS/METHODS: 131 eyes from 111 patients undergoing solitary or combined EK (52 DSAEK (40.0%) and 79 DMEK (60.0%)) at Southend University Hospital between January 2020 and February 2022 with a minimum follow-up of 6 months were evaluated. Patients suspected of having CMO underwent spectral-domain macular optical coherence tomography (SD-OCT) Patients with diabetes were not included in this series. RESULTS: CMO was identified in 5.3% (n = 7) of cases, with 2 of these patients responding to topical corticosteroid treatment. The remaining 5 patients underwent intravitreal dexamethasone implant, with 1 patient requiring repeat implant due to CMO recurrence. All presented within 2 months postoperatively. 4 out of 5 eyes treated with intravitreal dexamethasone achieved a Snellen BCVA ≤6/9.5. 1 patient had an uncontrolled rise in intraocular pressure (IOP) despite maximal medical treatment requiring an urgent PreserFlo Ab-Externo MicroShunt. CONCLUSIONS: The use of intravitreal sustained-release dexamethasone implant in the management of post EK CMO refractory to topical therapy is effective and safe in most cases, but patients should be monitored and treated promptly for any secondary IOP response.


Assuntos
Transplante de Córnea , Edema Macular , Humanos , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Preparações de Ação Retardada/uso terapêutico , Glucocorticoides , Dexametasona , Injeções Intravítreas , Implantes de Medicamento/uso terapêutico , Tomografia de Coerência Óptica , Estudos Retrospectivos
17.
Eur J Ophthalmol ; 33(3): 1501-1505, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-36632008

RESUMO

PURPOSE: To show an alternative surgical technique for the introduction of the intravitreal fluocinolone acetonide (FAc) implant (Iluvien®) into the vitreous cavity using a 23-gauge (G) trocar if it is retained during its implantation in the subconjunctival space. METHODS: We describe the surgical procedure performed to solve the complication: The FAc implant was extracted from the subconjunctival space using flat retinal forceps. A 23-G trocar was inserted 3,5 mm to the limbus. The same flat retinal forceps were used to take the FAc implant and introduce it into the vitreous cavity using a 23-G trocar. RESULTS: The patient's best corrected visual acuity (BCVA) (Snellen) improved from 20/200 to 20/63 and the central macular thickness (CMT) was reduced from 610 microns (µm) to 215 µm after one week of the FAc implantation. He remained stable after 3 months of follow-up, with a BCVA of 20/63 and a CMT of 191 µm. His intraocular pressure (IOP) remained stable and the integrity of the implant was checked by indirect ophthalmoscopy. CONCLUSION: The introduction of the intravitreal FAc implant using a 23-gauge trocar constitutes a valid alternative if it is retained during its implantation in the subconjunctival space.The functionality of the implant remained intact in our patient.


Assuntos
Retinopatia Diabética , Edema Macular , Masculino , Humanos , Fluocinolona Acetonida/uso terapêutico , Glucocorticoides/uso terapêutico , Retinopatia Diabética/tratamento farmacológico , Injeções Intravítreas , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Implantes de Medicamento/uso terapêutico
18.
Eur J Ophthalmol ; 33(5): NP115-NP120, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36120856

RESUMO

INTRODUCTION: To report a successful application of dexamethasone implants in the treatment of a massive amount of persistent subretinal fluid (SRF) following a tractional retinal detachment (TRD) surgery. CASE REPORT: A 44-year-old woman was found to have SRF 1 week after a diabetic TRD surgery. The central macular thickness (CMT) reached up to 1.47 mm and remained high after a month's observation. For better restoration, 2 dexamethasone implants (Ozurdex) were applied at postoperative week 5 and 32 respectively and got good outcomes. The SRF decrease showed a close correlation with Ozurdex treatments: The CMT declined quickly in the next 16 weeks both after 2 times of Ozurdex applications (the linear regression slopes of CMT changes: -12.54 and -22.94, respectively). In contrast, in the interval of 2 injections, the CMT had few changes (the slope: -4.667) even if applying an anti-VEGF agent. Eventually, SRF was completely resolved 48 weeks after the surgery. DISCUSSION: Dexamethasone implant can be an option for effective treatment of persistent SRF after TRD repair, especially in some refractory cases. However, the mechanism remains unclear, and the treatment regimen needs to be explored based on more clinical trials.


Assuntos
Retinopatia Diabética , Descolamento Retiniano , Feminino , Humanos , Adulto , Descolamento Retiniano/tratamento farmacológico , Descolamento Retiniano/cirurgia , Líquido Sub-Retiniano , Vitrectomia , Dexametasona , Retinopatia Diabética/tratamento farmacológico , Estudos Retrospectivos , Implantes de Medicamento/uso terapêutico , Injeções Intravítreas , Tomografia de Coerência Óptica
19.
Arq Bras Oftalmol ; 86(2): 171-174, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-35170652

RESUMO

This case report aims to show the anatomical and functional results of a patient diagnosed as having cancer-associated retinopathy treated with a controlled-release dexamethasone implant (Ozurdex). Anatomical outcomes were assessed using spectral domain optical coherence tomography; and functional outcomes, by measuring visual acuity, microperimetry, and mutifocal electroretinography. The follow-up period was 1 year.


Assuntos
Retinopatia Diabética , Edema Macular , Síndromes Paraneoplásicas Oculares , Oclusão da Veia Retiniana , Humanos , Glucocorticoides , Síndromes Paraneoplásicas Oculares/complicações , Edema Macular/tratamento farmacológico , Oclusão da Veia Retiniana/tratamento farmacológico , Implantes de Medicamento/uso terapêutico , Estudos Prospectivos , Dexametasona , Tomografia de Coerência Óptica , Injeções Intravítreas , Retinopatia Diabética/complicações
20.
Eye (Lond) ; 37(2): 280-284, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-35043004

RESUMO

OBJECTIVE: We aimed to compare visual and anatomical outcome in vitrectomized and non-vitrectomized eyes treated with dexamethasone (DEX) implant due to diabetic macular oedema (DMO). DESIGN: Multicenter, retrospective, interventional study. PARTICIPANTS: 236 eyes from 234 patients with DMO with or without previous vitrectomy performed with follow-up of 12 months. METHODS: Records were reviewed for cases of DMO treated with DEX implant in vitrectomized and not vitrectomized eyes. Best corrected visual acuity (BCVA), central subfoveal thickness (CST), and intraocular pressure (IOP) were recorded at baseline and 12 months after treatment with DEX implants. Correlations between vitreous status and visual and anatomical outcome, as well as safety profile were analysed. MAIN OUTCOME MEASURES: BCVA and CST over follow-up period. SECONDARY OUTCOMES: cataract rate formation, intraocular pressure increase, number of implants needed. RESULTS: The non-vitrectomized group included 130 eyes (55.1%), the vitrectomized group included 106 eyes (44.9%). The groups were well balanced for age and gender (p = 0.540, and p = 0.053, respectively). Both groups showed statistically significant improvement in BCVA and CST (for all groups: p < 0.001). There was no significant difference between the groups in terms of change in vision (p = 0.89) and anatomy (p = 0.65). The mean number of DEX implants given during follow-up was 3.5 in both groups, and there was no significant difference between the groups (p = 0.81). CONCLUSION: We demonstrated similar anatomical and functional efficacy of DEX implant in non-vitrectomized and vitrectomized eyes. Its efficacy was not influenced by full vitrectomy for diabetic retinopathy complications. Safety profile was well balanced between groups.


Assuntos
Retinopatia Diabética , Edema Macular , Humanos , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Edema Macular/cirurgia , Glucocorticoides/uso terapêutico , Retinopatia Diabética/tratamento farmacológico , Retinopatia Diabética/cirurgia , Dexametasona/uso terapêutico , Estudos Retrospectivos , Implantes de Medicamento/uso terapêutico , Injeções Intravítreas , Resultado do Tratamento
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