Six-month results from the GALILEO study show promise for VEGF Trap-Eye
"VEGF Trap-Eye (Eylea, Bayer HealthCare, Leverkusen, Germany) has been shown to be efficacious and safe in ME due to neovascular age-related macular degeneration," he continued. "As both entities share common pathogenetic mechanisms including hyperexpression of VEGF, the GALILEO Study aimed to assess VEGF Trap-Eye as a treatment possibility in this context."
In the study group, just over 60% of the patients receiving VEGF Trap-Eye gained 15 letters or more. This was compared with only a little more than 20% in the sham injection group. The mean number of letters gained was 18 for patients who had received VEGF TrapEye and only 3.3 letters for those who had sham injections, which is statistically significant. Additionally, the central retinal thickness, as measured by OCT, was found to be much larger in the VEGF TrapEye group.
"An increase in intraocular pressure was reported in 9.6% of all patients treated with VEGF Trap-Eye," revealed Prof. Holz. "It is known that this may occur with any intravitreal injection. Here, it did not represent a serious problem. As the same volume was always injected intravitreally, there is no way to avoid this infrequent side effect. The same holds true for conjunctival haemorrhage."
"This study shows that VEGF Trap-Eye given monthly was efficacious in patients with central retinal vein occlusion (CRVO) and secondary ME. The safety provided overall was favourable. The study results indicate a much better functional and morphological outcome in treated patients as compared with patients in the sham arm," emphasized Prof. Holz.
He noted that the demonstrated efficacy of VEGF Trap-Eye in ME further underscores the successful therapeutic approach of inhibiting VEGF in eyes with hyperpermeable vessels.
"Interestingly, this therapeutic principle of antipermeability works both in hyperpermeability states of the retinal vasculature as well as of new vessels growing from the choroidal circulation. All anti-VEGF drugs (i.e., ranibizumab, bevacizumab and VEGF Trap-Eye) have been shown to improve the visual outcome significantly," he said. "Some lines of evidence may indicate that VEGF Trap-Eye potentially exerts its action over longer periods of time, although this hypothesis is not tested in the GALILEO Study."
"With the results of the GALILEO Study and the sister study (COPERNICUS)2 there is now ample evidence that it is meaningful to use VEGF Trap-Eye in the context of ME due to CRVO. In this respect it adds to the given armamentarium of therapeutic approaches including anti-VEGF therapies as well as steroids," clarified Prof. Holz.
He went on to explain that when the GALILEO Study was designed, there was no approved pharmacological therapy for ME due to CRVO. This study has meant that this has now changed and any future studies would no longer need a comparison to sham treatment.
"It may be desirable to pursue head-to-head studies in the future including corticosteroid treatment approaches. Furthermore, longer follow-up and definition of best PRN regimens may be prudent," Prof. Holz concluded.
1. F.G. Holz et al., Br. J. Ophthalmol., 2013;97(3):278–284.
2. D. Boyer et al., Ophthalmology, 2012;119:1024–1032.