Evaluación terapéutica del bevacizumab, intravítreo, en el tratamiento del edema macular diabético difuso.

Tesis (Doctor en Medicina) UANL, 2011.

Hallazgos tomográficos como predictores del resultado funcional en edema macular secundario a oclusiones venosas retinianas

INTRODUCCIÓN: El Edema Macular (EM) es la principal causa de perdida de agudeza visual en pacientes con Oclusión Venosa Retiniana (OVR); luego del tratamiento, algunos pacientes persisten con mala agudeza visual. OBJETIVO: Realizar una Revisión Sistemática de la Literatura (RSL), para identificar la evidencia existente sobre factores tomográficos que predicen el resultado visual en pacientes con EM secundario a OVR. FUENTE DE LA INFORMACIÓN: PUBMED, MEDLINE, EMBASE, LILACS, COCHRANE, literatura gris. SELECCIÓN DE LOS ESTUDIOS: Ensayos Clínicos Controlados (ECC) y estudios observacionales analíticos. EXTRACCIÓN Y SÍNTESIS DE LOS DATOS: Dos investigadores seleccionaron los artículos de forma independiente. Se realizó una síntesis cualitativa de la información siguiendo las recomendaciones de la declaración PRISMA 2009. MEDIDAS Y DESENLACE PRINCIPAL: Grosor Retiniano Central (GRC), integridad de Banda Elipsoide e Integridad de Membrana Limitante Externa (MLE), determinados por SD OCT. El desenlace principal es la Agudeza Visual Mejor Corregida (AVMC) a los 6, 12,18 y/o 24 meses. RESULTADOS: Se identificaron 872 abstract y se incluyeron 8 artículos en el análisis cualitativo. Seis estudios evaluaron el GRC sin encontrar asociación con resultado visual final. Solo 2 estudios evaluaron y encontraron asociación estadísticamente significativa de la integridad de la MLE con el desenlace visual, Kang, H 2012 (r2 0,51 p 0,000), Rodriguez, F 2014 (p< 0,001). La integridad de la BE fue asociada a pronostico visual en 4 de 5 estudios que evaluaron esta variable, con resultados estadísticamente significativos. La AVMC de base también se asocio con desenlace visual en 4 de 5 estudios que la evaluaron. El mejor modelo que predice el resultado funcional según el estudio de Kang, H 2012 fue: Integridad de MLE, integridad de BE y AVMC de base (R2 0,671 p 0,000), a los 12 meses de seguimiento. CONCLUSION: La evidencia actual sugiere que la integridad de la BE y la MLE son predictores del resultados funcional en pacientes con EM secundario a OVR después de 6 o mas meses de seguimiento. Es necesario la realización de estudios controlados para llegar a resultados mas concluyentes.

Grosor macular luego de tratamiento con Ranibizumab o Bevacizumab en degeneración macular relacionada con la edad

Introducción: El manejo actual de la degeneración macular relacionada con la edad (DMRE) neovascular está basado en la terapia antiangiogénica con inhibidores del factor de crecimiento vascular endotelial (VEGF) entre los cuales se encuentra el Ranibizumab y el Bevacizumab. El seguimiento se hace mediante medidas funcionales (agudeza visual) y anatómicas (grosor macular por tomografía óptica coherente). Objetivo: comparar el comportamiento del grosor macular luego del tratamiento con cada medicamento Metodología: es un estudio descriptivo multicéntrico, para comparar los cambios de grosor macular por OCT y la agudeza visual a los 3, 6, 9, 12, 18 y 24 meses luego del tratamiento con Bevacizumab y Ranibizumab. Resultados: Se incluyeron 127 ojos (93 tratados con Bevacizumab y 34 tratados Ranibizumab). El grosor macular central inicial fue de 241 micras en el primer grupo y 242.5 en el segundo. Éste disminuyó con respecto al inicial 24.5 y 18 micras a los 3 meses, 15 y 11.5 a los 6 meses respectivamente. Al año aumentó 3 y 5 micras y a los 2 años disminuyó 13 y aumentó 21 micras respectivamente. No hubo diferencias estadísticamente significativas en los grosores entre los grupos. Discusión: Los grosores maculares centrales, del promedio de los 3 y 6 mm de la fóvea se mantuvieron estables durante los 2 años de seguimiento. La agudeza visual también se mantuvo estable en ambos grupos. No se encontró correlación entre la agudeza visual y el grosor macular

El efecto de los anti inflamatorios no esteroideos sobre el espesor retiniano, inflamación y agudeza visual posterior a la extracción de catarata: un estudio prospectivo comparando nepafenac y dexametasona

Objetivos: Comparar el volumen macular total (VMT) y espesor retiniano, la agudeza visual mejor corregida (AVCC) y la incidencia de edema macular post cirugía de catarata, en ojos tratados con nepafenac 0.1%, dexametasona 0.1% o la combinación de los dos. Métodos: En una estudio prospectivo, aleatorizado, controlado y ciego para el observador, se aleatorizaron 147 ojos con catarata para recibir dexametasona 0.1% cada 6 horas por 12 días de forma postoperatoria, nepafenac 0.1% cada 8 horas antes de cirugía y por 15 días postoperatorios o la combinación de los dos. Los desenlaces medidos fueron presión intraocular a la primera y sexta semana, AVCC, VMT (medido por OCT), espesor foveal y perifoveal, y la presencia o ausencia de edema macular (espesor foveal > 240 micras, medido por OCT) a las 6 semanas. Resultados: En la primera semana, la presión intraocular fue significativamente mayor en el Grupo de dexametasona (p<0.05), y luego fue similar entre grupos a la sexta semana. No se presentaron diferencias significativas en agudeza visual. El espesor perifoveal fue significativamente menor en el grupo de nepafenac (p<0.05). La incidencia de edema macular medido por OCT fue de 7.5% (11 ojos); de estos 5 pertenecían al grupo dexametasona, tres al Grupo de Nepafenac y 3 ojos al Grupo de la combinación (p>0.05) Conclusión:. Los resultados demuestran que el nepafenac es por lo menos igual de efectivo para evitar la inflamación postoperatoria al compararlo con dexametasona, y adicionalmente podría ser útil para evitar el edema macular post cirugía de catarata.

Dyslipidemia and Diabetic Macular Edema: A Systematic Review and Meta-Analysis

Topic: A systematic review and meta-analysis of dyslipidemia and diabetic macular edema (DME). 

Clinical Relevance: Diabetic macular edema causes impairment of vision in patients with diabetes, and dyslipidemia has been reported as a risk factor for its development. A systematic review with a meta-analysis was undertaken to examine the evidence of an association between dyslipidemia and DME. 

Methods: We defined eligibility criteria as randomized controlled trials (RCTs) and cohort, case-control, and cross-sectional studies reporting on the relationship between blood lipid levels and DME. We performed a literature search in MEDLINE, PubMed, and Embase from inception to September 2014. We used the NewcastleeOttawa scale to assess the quality of case-control, cross-sectional, and cohort studies, and the Cochrane risk of bias tool for RCTs. 

Results: The search strategy identified 4959 publications. After screening, we selected 21 articles for review (5 cross-sectional, 5 cohort, 7 case-control, and 4 RCTs). Meta-analysis of case-control studies revealed that mean levels of total serum cholesterol (TC), low-density lipoproteins (LDLs), and serum triglycerides (TGs) were significantly higher in patients with DME compared with those without DME (TC: 30.08; 95% confidence interval [CI], 21.14e39.02; P < 0.001; LDL: 18.62; 95% CI, 5.80e31.43; P < 0.05; TG: 24.82; 95% CI, 9.21e40.42; P < 0.05). Meta-analysis of RCTs did not show significant risk in worsening of hard exudates and severity of DME in the lipid-lowering group compared with placebo (hard exudates: relative risk, 1.00; 95% CI, 0.47e2.11; P ¼ 1.00; DME: relative risk, 1.18; 95% CI, 0.75e1.86; P ¼ 0.48). 

Conclusions: Despite evidence from the cohort studies and meta-analysis of the case-control studies suggesting a strong relationship between lipid levels and DME, this was not confirmed by the meta-analysis that included only prospective RCTs. Therefore, given the significant public health relevance of the topic, the relationship between lipid levels and DME deserves further investigation.

Recurrent uveitis, cystoid macular edema and pericarditis in Lyme disease.

Lyme disease has been associated with many systemic and ocular complications. The authors' patient, a 26-year-old man, developed recurrent pars planitis with two episodes of acute pericarditis. Extensive medical investigations were negative except for a highly positive western blot for Borrelia burgdorferi. Specific antibiotic treatment for Lyme disease was followed by a long lasting period without any relapse.

Intravitreal injection versus sub-Tenon's infusion of triamcinolone acetonide for refractory diabetic macular edema: A randomized clinical trial

PURPOSE. To compare the effectiveness of posterior sub-Tenon's infusion (STi) and intravitreal injection (IVI) of triamcinolone acetonide (TA) for treatment of refractory diffuse diabetic macular edema.METHODS. Thirty-six phakic diabetic patients with refractory diffuse diabetic macular edema were prospectively enrolled. Patients randomly received either 40 mg STi or 4 mg IVI of TA. Comprehensive ophthalmic evaluation was performed at baseline and 1, 2, 4, 8 +/- 1, 12 +/- 2 and 24 +/- 2 weeks after treatment. Macular morphologic changes detected by optical coherence tomography and visual acuity, intraocular pressure, and lens status were evaluated.RESULTS. Twenty-eight patients (28 eyes) completed the 24-week study. Central macular thickness was significantly reduced in the IVI group when compared with the STi group at 2, 4, 8, 12, and 24 weeks after treatment (P < 0.01). Mean visual acuities (in logarithm of the minimum angle of resolution [logMAR]) at week-4, -8, and -12 follow-up examinations were significantly higher in the IVI group (0.74, 0.75, and 0.82, respectively) when compared with the STi group (0.88, 0.88, and 0.90, respectively; P < 0.01). A significant change from baseline in mean intraocular pressure (mm Hg) was seen at weeks 4 (+/- 3.21) and 8 (+/- 3.35) in STi the group (P < 0.01), and at week 8 (+/- 2.78) in the IVI group (P < 0.05). No patient had cataract progression during the study.CONCLUSIONS. Although the number of patients and length of follow-up in this preliminary study were limited, the changes in central macular thickness and visual acuity observed after treatment suggest that IVI TA may be more effective than STi for the management of refractory diffuse diabetic macular edema. Further studies are needed to confirm these preliminary findings.

Single intravitreal bevacizumab injection effects on contrast sensitivity in macular edema from branch retinal vein occlusion

Purpose: To evaluate the effect of a single intravitreal bevacizumab injection on visual acuity, contrast sensitivity and optical coherence tomography-measured central macular thickness in eyes with macular edema from branch retinal vein occlusion. Methods: Seventeen eyes of 17 patients with macular edema from unilateral branch retinal vein occlusion were treated with a single bevacizumab injection. Patients were submitted to a complete evaluation including best corrected visual acuity, contrast sensitivity and optical coherence tomography measurements before treatment and one and three months after injection. Visual acuity, contrast sensitivity and optical coherence tomography measurements were compared to baseline values. Results: Mean visual acuity measurement improved from 0.77 logMAR at baseline to 0.613 logMAR one month after injection (P=0.0001) but worsened to 0.75 logMAR after three months. Contrast sensitivity test demonstrated significant improvement at spatial frequencies of 3, 6, 12 and 18 cycles/degree one month after injection and at the spatial frequency of 12 cycles/degree three months after treatment. Mean +/- standard deviation baseline central macular thickness (552 +/- 150 mu m) reduced significantly one month (322 +/- 127 mu m, P=0.0001) and three months (439 perpendicular to 179 mu m, P=0.01) after treatment. Conclusions: Bevacizumab injection improves visual acuity and contrast sensitivity and reduces central macular thickness one month after treatment. Visual acuity returns to baseline levels at the 3-month follow-up, but some beneficial effect of the treatment is still present at that time, as evidenced by optical coherence tomography-measured central macular thickness and contrast sensitivity measurements.

INTRAVITREAL INJECTION OF RANIBIZUMAB DURING CATARACT SURGERY IN PATIENTS WITH DIABETIC MACULAR EDEMA

Purpose: To investigate macular thickness and visual acuity changes after 1 intravitreal injection of 0.5-mg ranibizumab during phacoemulsification cataract surgery in eyes with diabetic macular edema refractory to laser treatment. Methods: Eleven eyes of 11 patients with diabetic macular edema refractory to modified Early Treatment Diabetic Retinopathy Study laser therapy received intravitreal during phacoemulsification cataract surgery. Comprehensive ophthalmic evaluation was performed preoperatively and at 1, 4, 8 +/- 1, and 12 +/- 2 weeks postoperatively. Main outcome measures included central subfield thickness and best-corrected Early Treatment Diabetic Retinopathy Study visual acuity. Results: Eleven patients completed the 12-week study visit. Mean central subfield thickness (+/- SEM) was 399.82 +/- 29.50 mu m at baseline and did not change significantly at any postoperative study visit (P > 0.05). Mean (+/- SEM) best-corrected Early Treatment Diabetic Retinopathy Study visual acuity was 0.95 +/- 0.13 logarithm of the minimum angle of resolution (20/200) at baseline and was significantly improved at Weeks 1 (0.38 +/- 0.13), 4 (0.38 +/- 0.11), 8 (0.35 +/- 0.08), and 12 (0.46 +/- 0.12) after treatment (P < 0.05). Conclusion: In this case series of patients with diabetic macular edema refractory to laser therapy, intravitreal ranibizumab administered during cataract surgery was associated with no significant change in central subfield thickness postoperatively. Significant improvement in best-corrected Early Treatment Diabetic Retinopathy Study visual acuity was observed after treatment, likely because of cataract removal. RETINA 32:1799-1803, 2012

Safety and Efficacy of Ranibizumab in Diabetic Macular Edema (RESOLVE Study): A 12-month, randomized, controlled, double-masked, multicenter phase II study

The expression of vascular endothelial growth factor (VEGF) is elevated in diabetic macular edema (DME). Ranibizumab binds to and inhibits multiple VEGF variants. We investigated the safety and efficacy of ranibizumab in DME involving the foveal center.