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ABSTRACT Purpose: To compare visual acuity, macular thickness, and the area of active neovascularization based on fluorescein angiography outcomes associated with standard single-spot panretinal photocoagulation in the Early Treatment Diabetic Retinopathy Study (ETDRS) pattern combined with intravitreal ranibizumab injection versus multiple-spot full scatter (PASCAL) panretinal photocoagulation combined with intravitreal ranibizumab injection versus intravitreal injection alone in patients with proliferative diabetic retinopathy. Methods: Patients with proliferative diabetic retinopathy and no prior laser treatment were randomly assigned to receive three different types of treatment. Panretinal photocoagulation in the ETDRS group was administered in two sessions (weeks 0 and 2), and panretinal photocoagulation in the PASCAL group was administered in one session (week 0). Intravitreal injection of ranibizumab was administered at the end of the first laser session in both the ETDRS and PASCAL groups and at week 0 in the intravitreal injection group. Comprehensive ophthalmic evaluations were performed at baseline and every 4 weeks through week 48. Results: Thirty patients (n=40 eyes) completed the 48-week study period. After treatment, best-corrected visual acuity was significantly (p<0.05) improved at all follow-up visits in the group receiving intravitreal injection alone, at all but week 4 in the ETDRS group, and at all but weeks 4 and 8 for the PASCAL group. A significant decrease in central subfield macular thickness was observed in the PASCAL group at weeks 4, 8, and 48; only at week 48 in the intravitreal injection group; and never in the ETDRS group. There was no significant difference among the three treatment groups with respect to change from baseline to week 48 in best-corrected visual acuity, central subfield macular thickness, or fluorescein leakage from active neovascularization in best-corrected visual acuity, central subfield macular thickness, or fluorescein leakage from active neovascularization. Conclusions: Intravitreal injection alone or combined with single- or multiple-spot panretinal photocoagulation yielded similar outcomes with respect to mean change in best-corrected visual acuity, central subfield macular thickness, and fluorescein leakage from active neovascularization at up to one-year of follow-up. All subjects provided written informed consent to participate (NCT02005432 in clinicaltrials.gov).
RESUMO Objetivo: Comparar as medidas de acuidade visual, espessura macular central e área de neovasos ativos na angiofluoresceinografia submetidos a panfotocoagulação retiniana padrão ETDRS associado a injeção intravítrea de ranibizumabe versus panfotocoagulação padrão PASCAL associado a injeção intravítrea de ranibizumabe versus somente injeção intravítrea de ranibizumabe em pacientes com retinopatia diabética proliferativa. Métodos: Pacientes com retinopatia diabética proliferativa e virgens de tratamento, randomicamente divididos nas três diferentes terapias retinianas. Panfotocoagulação no grupo ETDRS em 2 sessões (semanas 0 e 2) e no grupo PASCAL, na semana 0. Injeção intravítrea de ranibizumabe realizado ao fim da primeira sessão de laser em ambos os grupos: ETDRS e PASCAL, e na semana 0 no grupo injeção intravítrea de ranibizumabe. Avaliações oftalmológicas, tomografia de coerência óptica e angiofluoesceinografia realizados na visita basal e a cada 4 semanas por 48 semanas. Resultados: Trinta pacientes (n=40 olhos) completaram as 48 semanas de seguimento. Após o tratamento, a acuidade visual melhorou significantemente em todas a visitas no grupo injeção intravítrea de ranibizumabe (p<0,05); em todas exceto na semana 4 no grupo ETDRS, em todas exceto nas semanas 4 e 8 no grupo PASCAL. Redução significativa na espessura do subcampo central foi evidenciada no grupo PASCAL nas semanas 4, 8 e 48; somente na semana 48 no grupo injeção intravítrea de ranibizumabe, e em nenhuma visita no grupo ETDRS. Redução também na área de neovasos ativos em todas as visitas em todos os grupos. Não houve diferença significante entre os três grupos com relação a mudança media na medidas de acuidade visual, espessura macular central ou área de neovasos ativos da visita inicial para a semana 48. Conclusões: Somente IVB ou este associado a panfotocoagulação ETDRS ou PASCAL, apresentaram efeitos semelhantes em relação a medidas de acuidade visual, espessura do subcampo central e área de neovasos ativos no decorrer de 48 semanas de seguimento.
Subject(s)
Humans , Angiogenesis Inhibitors/therapeutic use , Diabetes Mellitus , Diabetes Mellitus/drug therapy , Diabetic Retinopathy , Diabetic Retinopathy/surgery , Diabetic Retinopathy/drug therapy , Treatment Outcome , Laser Coagulation , Intravitreal Injections , Ranibizumab/therapeutic useABSTRACT
PURPOSE: Nonproliferative (NPDR) and proliferative diabetic retinopathy (PDR) without diabetic macular edema (DME) affect millions of individuals living with diabetes throughout the world. There is increasing data on various management strategies for such patients, but there is limited consensus on how the data should be adopted into clinical practice. METHODS: This literature review and editorial presents and synthesizes the current evidence for various management paradigms for NPDR and PDR without DME. RESULTS: Retina specialists are an integral member of the diabetes management team, and should encourage patients on the importance of glycemic and cardiovascular optimization for both systemic and retinopathy risk factor reduction. The diabetic retinopathy severity scale (DRSS) is now an approvable endpoint for clinical trials in the United States, therefore becoming more clinically relevant. For PDR without DME, the Diabetic Retinopathy Study (DRS) and the Early Treatment Diabetic Retinopathy Study (ETDRS) established the standard of care with panretinal photocoagulation (PRP). Laser parameters have since evolved to include less intense and earlier intervention. Studies have recently demonstrated that anti-vascular endothelial growth factor (VEGF) treatment of PDR is effective at regressing neovascularization and improving DRSS levels in many patients. Further evidence is required to determine optimal treatment frequency, duration, and retreatment criteria, in the real world. There are concerns for adverse events in patients being lost to follow up during anti-VEGF treatment. For NPDR without DME, the standard of care has been a wait-and-watch approach. Data within the DRS and the ETDRS suggest that PRP for severe NPDR can be an option for select patients as well. Multiple clinical trials have now demonstrated that anti-VEGF treatment can improve the DRSS score in NPDR. Further studies are required to assess whether this positively affects long-term visual outcomes, and whether the benefits outweigh the risks in the real world for routine use. CONCLUSIONS: There is cumulative evidence demonstrating the efficacy of various treatment options for NPDR and PDR without DME. Currently, patients would most likely benefit from thoughtful management strategies that are tailored to the individual patient.
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OBJECTIVE: To compare two different laser strategies of panretinal photocoagulation for diabetic retinopathy. METHODS: Single-center, randomized study including 41 eyes treated with 577-nm multispot laser with a 20-ms pulse duration (group 1) or a 532-nm single-spot laser with a 100-ms pulse duration (group 2). The outcomes included best-corrected visual acuity (BCVA) and imaging changes at baseline, 6 and 12 months, laser parameters, and results of subjective pain analysis. RESULTS: At 12 months, the treatments did not differ significantly in BCVA, central retinal thicknesses (CRTs), improved macular edema, vitreomacular interface changes, patient-reported pain scores, or angiographic responses. Group 1 had significantly fewer treatment sessions but used more laser spots (p < 0.001). CONCLUSION: The multispot laser required fewer applications with more spots delivered to compensate for lower fluency, showing similar patient tolerance to single-spot laser. Both groups maintained the initial visual acuities and CRTs; about 50% of cases had vitreomacular interface changes and improved macular edema, with similar angiographic improvements after 12 months.
Subject(s)
Diabetic Retinopathy/surgery , Laser Coagulation/methods , Retina/surgery , Visual Acuity , Diabetic Retinopathy/diagnosis , Female , Fluorescein Angiography , Follow-Up Studies , Fundus Oculi , Humans , Male , Middle Aged , Prospective Studies , Retina/pathology , Tomography, Optical Coherence , Treatment OutcomeABSTRACT
PURPOSE: Intravitreal anti-vascular endothelial growth factor agents have been shown to reduce diabetic retinopathy (DR) progression; data on the effects of intravitreal corticosteroids on modifying disease severity are limited. This study evaluates the long-term effect of intravitreal dexamethasone implant (DEX) on the severity and progression of non-proliferative DR (NPDR). METHODS: This was a retrospective cohort study. Sixty eyes from 60 consecutive patients with NPDR and diabetic macular edema (DME) treated with dexamethasone implant (DEX group) and 49 eyes from consecutive 49 patients without DME requiring observation only. Fundus angiography images from baseline and after 24 months were graded by two masked assessors into mild, moderate and severe NPDR and PDR, according to the ETDRS classification. Patients were followed up 1-3 and 4-6 months after each DEX implant. Re-treatment with DEX implant was on a pro re nata basis. Records were reviewed for performance of panretinal photocoagulation. Main outcome was as follows: change of DR ≥ 1 grade and progression to proliferative diabetic retinopathy (PDR). RESULTS: Three eyes (5%) in the DEX group and 43 (87.8%) eyes in the control group progressed to PDR (P < 0.0001). Twenty-five eyes (41.7%) in the DEX group but none in the control group demonstrated an improvement in DR severity (P < 0.0001). CONCLUSION: This study provides the first long-term evidence that DEX implant has the potential to not only delay progression of DR and PDR development, but may also improve DR severity over 24 months. Better understanding of the effects of corticosteroids will help guide its use in the treatment pathway of DR.
Subject(s)
Dexamethasone/administration & dosage , Diabetic Retinopathy/drug therapy , Diabetic Retinopathy/pathology , Retina/drug effects , Aged , Aged, 80 and over , Dexamethasone/adverse effects , Diabetic Retinopathy/physiopathology , Disease Progression , Drug Implants , Female , Follow-Up Studies , Humans , Male , Middle Aged , Retina/physiopathology , Retrospective Studies , Severity of Illness Index , Visual Acuity/drug effects , Vitreous Body/drug effectsABSTRACT
Entre las enfermedades oculares, el glaucoma, está contemplado entre aquellas que más cambios han sufrido en muchos de sus variados aspectos con el decursar de los años. Objetivo: Describir el comportamiento clínico epidemiológico del glaucoma neovascular en el Servicio de Glaucoma del Centro Oftalmológico Carlos J Finlay de la provincia de Camagüey. Método: Se realizó un estudio descriptivo, longitudinal y retrospectivo para determinar el comportamiento clínico epidemiológico del glaucoma neovascular en pacientes atendidos en dicho centro durante el período del 1 de enero del 2006 al 31 de octubre del 2007. El universo estuvo constituido por sesenta pacientes y la muestra quedó constituida por cincuenta y dos de ellos. Las variables estudiadas fueron: grupos de edades, sexo, color de la piel, antecedentes patológicos personales generales, antecedentes patológicos personales oculares, síntomas, signos, agudeza visual y variantes de tratamiento en cada paciente. Resultados: Se encontraron un total de cincuenta y dos pacientes con glaucoma neovascular. Predominaron el grupo de edades de más de 60 años, el sexo masculino y la raza blanca. Primó la Diabetes Mellitus como antecedente patológico personal general y la Retinopatía Diabética como antecedente patológico ocular. Conclusiones: El glaucoma neovascular ocupa un lugar importante dentro de la oftalmología, si se tiene en cuenta sus fatales consecuencias oculares, se expone la descripción de sus características.
Among the ocular diseases, glaucoma is considered among those that more changes have suffered in many of its varied aspects with the course of the years. Objective: To describe the clinical epidemic behavior of the neovascular glaucoma in the Glaucoma Service at the Ophthalmologic Center Carlos J Finlay" of Camagüey province. Method: A descriptive, longitudinal and retrospective study was conducted to determine the clinical epidemic behavior of the neovascular glaucoma in patients attended in the Glaucoma Service at the Ophthalmologic Center Carlos J. Finlay of Camagüey province from January 1st, 2006 to October 31st, 2007. The universe was constituted by sixty patients and the sample was conformed by fifty-two of them. The studied variables were: age groups, sex, skin color, general personal pathological antecedents, ocular personal pathological antecedents, symptoms, signs and visual acuity and treatment variants in each patient. Results: A total of fifty-two patients with neovascular glaucoma were found. The age group of more than 60 years, the masculine sex and the white race prevailed. Diabetes mellitus as general personal pathological antecedent and diabetic retinopathy as ocular pathological antecedent predominated. Conclusions: The neovascular glaucoma occupies an important place in ophthalmology, if it is take into account its ocular fatal consequences; the description of its characteristics is exposed.