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1.
Sci Rep ; 14(1): 4690, 2024 02 26.
Artículo en Inglés | MEDLINE | ID: mdl-38409191

RESUMEN

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.


Asunto(s)
Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Humanos , Edema Macular/tratamiento farmacológico , Glucocorticoides/uso terapéutico , Dexametasona/uso terapéutico , Hemoglobina Glucada , Inhibidores de la Angiogénesis/uso terapéutico , Estudios Retrospectivos , Implantes de Medicamentos/uso terapéutico , Resultado del Tratamiento , Inyecciones Intravítreas , Diabetes Mellitus/inducido químicamente
2.
Semin Ophthalmol ; 39(3): 242-248, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38282256

RESUMEN

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.


Asunto(s)
Edema Macular , Oclusión de la Vena Retiniana , Masculino , Humanos , Femenino , Persona de Mediana Edad , Anciano , Glucocorticoides/uso terapéutico , Dexametasona , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Oclusión de la Vena Retiniana/complicaciones , Oclusión de la Vena Retiniana/diagnóstico , Oclusión de la Vena Retiniana/tratamiento farmacológico , Resultado del Tratamiento , Estudios Retrospectivos , Inyecciones Intravítreas , Implantes de Medicamentos/uso terapéutico
3.
Expert Opin Drug Saf ; 23(2): 199-205, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38234187

RESUMEN

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.


Asunto(s)
Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Humanos , Dexametasona , Edema Macular/tratamiento farmacológico , Retinopatía Diabética/tratamiento farmacológico , Estudios Retrospectivos , Implantes de Medicamentos/uso terapéutico , Inyecciones Intravítreas , Protocolos Clínicos , Glucocorticoides , Resultado del Tratamiento , Inhibidores de la Angiogénesis
5.
Eur J Ophthalmol ; 34(1): NP90-NP95, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37350018

RESUMEN

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®.


Asunto(s)
Edema Macular , Enfermedades de la Retina , Distrofia Macular Viteliforme , Humanos , Femenino , Persona de Mediana Edad , Distrofia Macular Viteliforme/diagnóstico , Distrofia Macular Viteliforme/tratamiento farmacológico , Dexametasona , Enfermedades de la Retina/diagnóstico , Epitelio Pigmentado de la Retina , Tomografía de Coherencia Óptica , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Inyecciones Intravítreas , Implantes de Medicamentos/uso terapéutico
6.
Eur J Ophthalmol ; 34(1): 233-244, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37475207

RESUMEN

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.


Asunto(s)
Quistes , Retinopatía Diabética , Edema Macular , Oftalmología , Humanos , Fluocinolona Acetonida , Retinopatía Diabética/tratamiento farmacológico , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Tomografía de Coherencia Óptica , Retina , Inyecciones Intravítreas , Implantes de Medicamentos/uso terapéutico , Estudios Retrospectivos
7.
Int Ophthalmol ; 43(12): 4639-4649, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37697082

RESUMEN

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.


Asunto(s)
Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Humanos , Femenino , Persona de Mediana Edad , Anciano , Masculino , Glucocorticoides/uso terapéutico , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Retinopatía Diabética/complicaciones , Retinopatía Diabética/diagnóstico , Retinopatía Diabética/tratamiento farmacológico , Estudios Prospectivos , Fluocinolona Acetonida/uso terapéutico , Implantes de Medicamentos/uso terapéutico , Inyecciones Intravítreas
8.
BMJ Open Ophthalmol ; 8(1)2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37541745

RESUMEN

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.


Asunto(s)
Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Humanos , Edema Macular/tratamiento farmacológico , Glucocorticoides/efectos adversos , Dexametasona/efectos adversos , Estudios Prospectivos , Factor A de Crecimiento Endotelial Vascular/uso terapéutico , Implantes de Medicamentos/uso terapéutico , Inyecciones Intravítreas , Retinopatía Diabética/complicaciones , Factores de Crecimiento Endotelial Vascular/uso terapéutico , Diabetes Mellitus/inducido químicamente
9.
Ophthalmologica ; 246(3-4): 238-244, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37552956

RESUMEN

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.


Asunto(s)
Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Humanos , Dexametasona , Diabetes Mellitus/inducido químicamente , Diabetes Mellitus/tratamiento farmacológico , Retinopatía Diabética/complicaciones , Retinopatía Diabética/diagnóstico , Retinopatía Diabética/tratamiento farmacológico , Implantes de Medicamentos/uso terapéutico , Glucocorticoides , Inyecciones Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Estudios Retrospectivos , Resultado del Tratamiento
10.
J Ocul Pharmacol Ther ; 39(7): 449-455, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37384926

RESUMEN

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.


Asunto(s)
Retinopatía Diabética , Edema Macular , Uveítis , Humanos , Glucocorticoides/uso terapéutico , Edema Macular/tratamiento farmacológico , Estudios Retrospectivos , Agudeza Visual , Fluocinolona Acetonida/uso terapéutico , Uveítis/tratamiento farmacológico , Inyecciones Intravítreas , Tomografía de Coherencia Óptica , Implantes de Medicamentos/uso terapéutico , Retinopatía Diabética/tratamiento farmacológico
11.
Zhonghua Yan Ke Za Zhi ; 59(5): 398-403, 2023 May 11.
Artículo en Chino | MEDLINE | ID: mdl-37151009

RESUMEN

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.


Asunto(s)
Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Humanos , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Glucocorticoides/uso terapéutico , Dexametasona/uso terapéutico , Retinopatía Diabética/tratamiento farmacológico , Estudios Retrospectivos , Implantes de Medicamentos/uso terapéutico , Inyecciones Intravítreas , Diabetes Mellitus/tratamiento farmacológico
12.
Drug Des Devel Ther ; 17: 961-975, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37020801

RESUMEN

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.


Asunto(s)
Retinopatía Diabética , Fluocinolona Acetonida , Edema Macular , Enfermedades de la Retina , Humanos , Retinopatía Diabética/tratamiento farmacológico , Implantes de Medicamentos/uso terapéutico , Fluocinolona Acetonida/administración & dosificación , Fluocinolona Acetonida/farmacología , Fluocinolona Acetonida/uso terapéutico , Glucocorticoides/uso terapéutico , Inyecciones Intravítreas , Edema Macular/tratamiento farmacológico , Enfermedades de la Retina/tratamiento farmacológico , Antiinflamatorios/farmacología , Antiinflamatorios/uso terapéutico
13.
Artículo en Inglés | MEDLINE | ID: mdl-37107744

RESUMEN

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.


Asunto(s)
Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Humanos , Edema Macular/tratamiento farmacológico , Edema Macular/complicaciones , Retinopatía Diabética/tratamiento farmacológico , Glucocorticoides/uso terapéutico , Dexametasona/uso terapéutico , Análisis Costo-Beneficio , Factor A de Crecimiento Endotelial Vascular , Estudios Retrospectivos , Implantes de Medicamentos/uso terapéutico , Resultado del Tratamiento , Diabetes Mellitus/tratamiento farmacológico
14.
Eur Rev Med Pharmacol Sci ; 27(5): 1743-1758, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36930471

RESUMEN

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.


Asunto(s)
Edema Macular , Uveítis , Humanos , Niño , Glucocorticoides/uso terapéutico , Estudios Retrospectivos , Resultado del Tratamiento , Edema Macular/tratamiento farmacológico , Agudeza Visual , Inyecciones Intravítreas , Dexametasona/uso terapéutico , Uveítis/tratamiento farmacológico , Uveítis/complicaciones , Implantes de Medicamentos/uso terapéutico
15.
Eur Rev Med Pharmacol Sci ; 27(5): 1759-1766, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36930491

RESUMEN

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.


Asunto(s)
Retinopatía Diabética , Edema Macular , Humanos , Fluocinolona Acetonida/uso terapéutico , Glucocorticoides/uso terapéutico , Retinopatía Diabética/tratamiento farmacológico , Tomografía de Coherencia Óptica , Factores de Crecimiento Endotelial/uso terapéutico , Proyectos Piloto , Pruebas del Campo Visual , Edema Macular/tratamiento farmacológico , Inyecciones Intravítreas , Implantes de Medicamentos/uso terapéutico
16.
Eur J Ophthalmol ; 33(5): 1903-1910, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36919243

RESUMEN

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.


Asunto(s)
Trasplante de Córnea , Edema Macular , Humanos , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Preparaciones de Acción Retardada/uso terapéutico , Glucocorticoides , Dexametasona , Inyecciones Intravítreas , Implantes de Medicamentos/uso terapéutico , Tomografía de Coherencia Óptica , Estudios Retrospectivos
17.
Eur J Ophthalmol ; 33(3): 1501-1505, 2023 May.
Artículo en Inglés | MEDLINE | ID: mdl-36632008

RESUMEN

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.


Asunto(s)
Retinopatía Diabética , Edema Macular , Masculino , Humanos , Fluocinolona Acetonida/uso terapéutico , Glucocorticoides/uso terapéutico , Retinopatía Diabética/tratamiento farmacológico , Inyecciones Intravítreas , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Implantes de Medicamentos/uso terapéutico
18.
Eur J Ophthalmol ; 33(5): NP115-NP120, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36120856

RESUMEN

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.


Asunto(s)
Retinopatía Diabética , Desprendimiento de Retina , Femenino , Humanos , Adulto , Desprendimiento de Retina/tratamiento farmacológico , Desprendimiento de Retina/cirugía , Líquido Subretiniano , Vitrectomía , Dexametasona , Retinopatía Diabética/tratamiento farmacológico , Estudios Retrospectivos , Implantes de Medicamentos/uso terapéutico , Inyecciones Intravítreas , Tomografía de Coherencia Óptica
19.
Arq Bras Oftalmol ; 86(2): 171-174, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-35170652

RESUMEN

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.


Asunto(s)
Retinopatía Diabética , Edema Macular , Síndromes Paraneoplásicos Oculares , Oclusión de la Vena Retiniana , Humanos , Glucocorticoides , Síndromes Paraneoplásicos Oculares/complicaciones , Edema Macular/tratamiento farmacológico , Oclusión de la Vena Retiniana/tratamiento farmacológico , Implantes de Medicamentos/uso terapéutico , Estudios Prospectivos , Dexametasona , Tomografía de Coherencia Óptica , Inyecciones Intravítreas , Retinopatía Diabética/complicaciones
20.
Eye (Lond) ; 37(2): 280-284, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-35043004

RESUMEN

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.


Asunto(s)
Retinopatía Diabética , Edema Macular , Humanos , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Edema Macular/cirugía , Glucocorticoides/uso terapéutico , Retinopatía Diabética/tratamiento farmacológico , Retinopatía Diabética/cirugía , Dexametasona/uso terapéutico , Estudios Retrospectivos , Implantes de Medicamentos/uso terapéutico , Inyecciones Intravítreas , Resultado del Tratamiento
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