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GALILEO is a sham-controlled pivotal trial investigating the efficacy and safety of aflibercept (Eylea, Bayer/Regeneron Pharmaceuticals) for the treatment of macular edema secondary to central retinal vein occlusion. Primary and secondary efficacy analyses after 6 months of routine monthly injections show consistent statistically significant treatment benefits.
Reviewed by Jean-Francois Korobelnik, MD
Bordeaux, France-A new option for macular edema following central retinal vein occlusion (CRVO) is showing consistent, statistically significant treatment benefits.
Six-month results from a multicenter, randomized, double-masked, sham-controlled trial show that fixed monthly injections of aflibercept (Eylea, Bayer/Regeneron Pharmaceuticals) 2 mg in treatment-naïve patients with macular edema secondary to CRVO results in rapid and sustained gains in visual acuity, said Jean-Francois Korobelnik, MD.
The efficacy and safety of aflibercept for the treatment of macular edema secondary to CRVO is being investigated in twin international studies-GALILEO and COPERNICUS. Dr. Korobelnik, professor of ophthalmology, University Hospital Bordeaux, France, presented outcomes from the GALILEO study that enrolled 177 patients at 62 centers in Europe and Asia.
Eligible patients had central retinal thickness (CRT) of at least 250 µm and ETDRS best-corrected visual acuity (BCVA) ranging from 20/40 to 20/320. They were randomly assigned at baseline 3:2 to receive aflibercept 2 mg every 4 weeks (n = 106) or sham injection (n = 71). After 24 weeks, patients were treated as needed according to pre-specified re-treatment criteria, and after 52 weeks, sham patients became eligible for treatment with aflibercept.
Primary, secondary efficacy analyses
The proportion of eyes at 24 weeks with a BCVA gain from baseline of 3 or more lines was analyzed as the primary efficacy endpoint and showed a significant difference favoring the aflibercept arm over the sham-treated controls (60% versus 22%). Secondary efficacy outcomes pertaining to functional and anatomic improvements also showed a significant treatment benefit, and adverse event data showed aflibercept had a favorable safety profile.
GALILEO and COPERNICUS studies are the last studies in CRVO with placebo control arms in CRVO. In the future, this will not be ethical, as anti-vascular endothelial growth factor (VEGF) agents have demonstrated a strong benefit compared with natural history, Dr. Korobelnik noted.
The two treatment arms in GALILEO were similar in their baseline characteristics. The patients had a mean age of about 60 years and there was a slight predominance of men. Mean BCVA was about 52 letters; mean CRT was 639 µm in the sham arm and 683 µm in the aflibercept patients.
Eighty percent of sham patients completed follow-up at week 24 as did 91.5% of aflibercept patients. Mean change from baseline BCVA was 18 letters for the aflibercept arm versus 3.3 letters in the control group. Mean change in CRT was more than two-fold greater in the aflibercept arm compared with the controls, and the proportion of eyes with a dry retina (CRT <250 µm) was about three-fold higher for the active versus sham group (80% versus 26%). Analyses of time to first sustained 15-letter gain in BCVA and time to first sustained dryness were also highly in favor of the aflibercept arm.
“The most frequent ocular serious adverse events in the aflibercept arm were macular edema and reduced visual acuity, but these events are related to the disease being treated rather than to the anti-VEGF treatment. There were no APTC events reported,” Dr. Korobelnik said.OT
Jean-Francois Korobelnik, MD
Dr. Korobelnik is a consultant and advisory board member for Bayer. The 6-month results of the GALILEO study were published online in January 2013 (Holz FG, et al. VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study. Br J Ophthalmol. 2013 Jan 7. [Epub ahead of print]). This article is based on Dr. Korobelnik’s presentation at the 2012 meeting of the American Academy of Ophthalmology.