[New perspectives in the approach to central retinal vein occlusion].
OBJECTIVE
The COPERNICUS and GALILEO trials were designed to evaluate the safety and efficacy of intravitreal injection of 2mg of aflibercept in the treatment of macular edema secondary to central retinal vein occlusion.


METHODS
Two phase III randomized, double-masked trials: COPERNICUS in North America (188 patients) and galileo in Europe and Asia (177 patients). In COPERNICUS, the patients in the treatment group received monthly injections of 2mg aflibercept for 6 months and later continued with strict PRN treatment with monthly follow-up every 6 months and with a minimum of 3-monthly follow up for 1 year. Patients in the placebo group could receive treatment after the sixth month, with similar treatment regimens and follow-up to the treatment group. In contrast, in galileo, the placebo group received no PRN treatment until 1 year of follow-up and during the first 6 months, followup visits were bi-monthly.


RESULTS
The treatment group in COPERNICUS showed a mean improvement of 13 letters versus the placebo group (1.5 letters) at week 100 of follow-up. In galileo, the mean best corrected visual acuity at 76 weeks were 13.7 and 6.6 in the treatment and placebo groups, respectively.


CONCLUSIONS
Early treatment with intravitreal afliberceptin achieves better results than when treatment is delayed by 6 months or 1 year. The visual benefits obtained with the drug are affected by the reduction in the frequency of monitoring during follow-up.
Vissum Madrid, Madrid, España; Jefa de la Unidad de Retina y Vítreo, Hospital Universitario Ramón y Cajal, Madrid, España; Profesora asociada Universidad de Alcalá de Henares, Alcalá de Henares, Madrid, España; Sociedad Española de la Retina y Vítreo, Instituto de Salud Carlos III, Madrid, España; Red Temática de Investigación Cooperativa OFTARED, Instituto de Salud Carlos III, Madrid, España. Electronic address: figueroa@servicom2000.com.
M S
MS
Figueroa
D020533:Angiogenesis Inhibitors / Q000493:pharmacokinetics / Q000627:therapeutic use*; D015415:Biomarkers; D017326:Clinical Trials, Phase III as Topic; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006801:Humans; D008269:Macular Edema / Q000188:drug therapy* / Q000209:etiology; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D040262:Receptors, Vascular Endothelial Growth Factor / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000493:pharmacokinetics / Q000627:therapeutic use*; D015861:Retinal Neovascularization / Q000188:drug therapy* / Q000209:etiology; D012170:Retinal Vein Occlusion / Q000150:complications*; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects
D020533:Angiogenesis Inhibitors; D015415:Biomarkers; D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor
Aflibercept; Anti- vegf; Antiangiogenicos intravitreos; Central retinal vein occlusion; Edema macular; Intravitreal antiangiogenics; Macular edema; Oclusion de vena central de la retina; copernicus; galileo