Evolución clínica de pacientes con degeneración macular asociada a la edad de tipo exudativo-hemorrágico tratados con ranibizumab. Estudio Eye2Eye / Clinical course of patients with exudative-haemorrhagic age-related macular degeneration treated with ranibizumab. Eye2Eye study
Arch. Soc. Esp. Oftalmol
; 88(6): 216-222, jun. 2013. tab, graf
Article
in Spanish
| IBECS
| ID: ibc-113281
Responsible library:
ES1.1
Localization: BNCS
RESUMEN
Objetivo:
Evaluar el cambio medio de la mejor agudeza visual corregida (MAVC) en pacientes con degeneración macular asociada a la edad exudativa-hemorrágica (DMAE-EH) a los 12 meses de tratamiento con ranibizumab.Métodos:
Estudio observacional, retrospectivo, multicéntrico y nacional, en dos grupos de pacientes con DMAE-EH primer ojo afectado (grupo 1) y segundo ojo afectado (grupo 2), teniendo afectado el primer ojo. Se incluyeron pacientes ≥ 50 años, diagnosticados de neovascularización coroidea subfoveal activa principal o recurrente secundaria a DMAE-EH.Resultados:
Se incluyó a 184 pacientes (91 en grupo 1 y 93 en grupo 2), edad media ± DE de 75,3 ± 7,5 años y 53,6% mujeres. La MAVC mostró una mejoría de la AV a los 12 meses de 9,3 ± 18,0 número de letras en el grupo 1 y 5,1 ± 16,8 número de letras en el grupo 2 (p < 0,0001 y p = 0,0042, respectivamente), sin observarse diferencias significativas (NS) entre ambos grupos. Las lesiones retinianas en la población total (basal vs 12 meses) fueron drusas (69,1 vs 61,1%), hemorragias maculares (59,0 vs 7,3%), exudados lipídicos (28,1 vs 8,2%) y desprendimiento del epitelio pigmentario (46,8 vs 19,0%). Los resultados de la tomografía de coherencia óptica (OCT) en la población total (basal vs 12 meses) mostraron una reducción del edema macular (73,6 vs 20,9%), del fluido subretiniano (71,3 vs 14,7%) y de quistes intrarretinianos (38,5 vs 19,7%), así como una reducción del grosor foveal medio de 377,4 ± 109,8 μm vs 249,1 ± 67,8 μm en el grupo 1 y de 354,1 ± 123,2 μm vs 254,6 ± 67,4 μm en el grupo 2, con p < 0,0001 en ambos grupos, sin observarse diferencias significativas entre grupos (AU)ABSTRACT
Objective:
To assess the mean best-corrected visual acuity (BCVA) change in patients with exudative-haemorrhagic age-related macular degeneration (EH-ARMD) after 12-month period of treatment with ranibizumab.Methods:
A retrospective, multicentre and national study of intravitreal administered ranibizumab was conducted on 2 groups of EH-ARMD patients only one eye affected (group 1) versus second eye affected (group 2), having the first one affected. Eligible subjects were ≥ 50 years old with primary or secondary active subfoveal EH-ARMD-related choroidal neovascularisation (CNV).Results:
A total of 184 patients (91 group 1 and 93 group 2) were included. Mean age (SD) was 75.3 (7.5) years, and 53.6% were women. The BCVA showed a VA improvement at 12 months of 9.3 (18.0) number of letters in group 1 and 5.1 (16.8) number of letters in group 2 (P<0.0001 and P=0.0042, respectively). No statistical differences between groups were observed. Lesion characteristics in the total population (baseline vs 12-month) were drusen (69.1% vs 61.1%), macular haemorrhages (59.0% vs 7.3%), lipid exudates (28.1% vs 8.2%), and retinal pigment epithelium detachment (46.8% vs 19.0%). The optical coherence tomography (OCT) in the total population (baseline vs 12-month) showed a reduction in macular oedema (73.6% vs 20.9%), subretinal fluids (71.3% vs 14.7%), and intraretinal cysts (38.5 vs 19.7%), as well as a reduction of the mean foveal thickness 377.4 ± 109.8 μm vs 249.1 ± 67.8 μm in group 1 and 354.1 ± 123.2 μm vs 254.6 ± 67.4 μm in group 2, P<0.0001, both groups, with no significant differences between groups.Conclusions:
Intravitreal administration of ranibizumab for a minimum of 12-months significantly improved the BCVA, decreased lesion characteristics, and reduced the initial mean foveal thickness in patients with CNV primary or secondary to EH-ARMD, both in patients with only one eye affected and in patients with a second eye affected, having the first one affected (AU)
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Collection:
National databases
/
Spain
Database:
IBECS
Main subject:
Choroidal Neovascularization
/
Macular Degeneration
/
Antibodies, Monoclonal
Type of study:
Controlled clinical trial
/
Observational study
Limits:
Humans
Language:
Spanish
Journal:
Arch. Soc. Esp. Oftalmol
Year:
2013
Document type:
Article
Institution/Affiliation country:
Hospital Regional Universitario Carlos Haya/España
/
Hospital San Eloy/España
/
Novartis Farmacéutica, S.A/España