TREAT WITH FORESIGHT
In the COPERNICUS study, patients treated with EYLEA gained ≥25 letters vs sham when treated within 2 months of diagnosis2
Primary end point: change from baseline in BCVA at Week 100
The difference in mean number of injections with EYLEA was statistically significant at Weeks 24, 52, and 100 vs ranibizumab
In a post hoc analysis, EYLEA demonstrated significantly fewer injections vs bevacizumab at Week 100c
- Rapid vision gains with EYLEA of 13.4 letters vs 11.4 for ranibizumab and 10.4 for bevacizumab at Week 24
- 52% of EYLEA-treated patients gained ≥15 letters vs 47% for ranibizumab and 45% for bevacizumab at Week 100
LEAVO was a multicenter, prospective, 3-arm, double-masked, randomized, noninferiority trial of anti-VEGF monotherapies in CRVO-related macular edema at 100 weeks.
- At Week 100, EYLEA demonstrated an ITT-adjusted mean BCVA difference of 2.23 letters vs ranibizumab (95% CI, –2.17 to 6.63 letters; P<0.001). At Week 52, bevacizumab achieved noninferiority to ranibizumab but was not noninferior at Week 100 (ITT adjusted mean BCVA difference, -1.73 letters (95% CI, -6.12 to 2.67 letters; P=0.07).
- Statistically significantly fewer injections vs ranibizumab and bevacizumab at 100 weeks.
- Exploratory post-hoc analysis vs bevacizumab: EYLEA was unlicensed during the study design period, therefore it was considered to be an investigative agent and comparisons with bevacizumab were post hoc.Bevacizumab has no marketing authorization for use in ophthalmic indications.
- In the COPERNICUS RCT, CRVO patients were randomized to receive EYLEA 2 mg or sham injections every 4 weeks up to Week 24. From Week 24 to 52, all patients were evaluated monthly and received EYLEA as needed (PRN). From Weeks 52 to 100, all patients were evaluated at least quarterly and received EYLEA PRN. Patients could be evaluated and dosed as frequently as every 4 weeks.
- In the ITT population, the mean injection interval was 10.0 weeks (95% CI, 8.7–11.3) in the EYLEA group compared with 6.6 weeks (95% CI, 5.2–8.0) in the ranibizumab group (P<0.001). At each visit, an experienced ophthalmological nurse tested BCVA using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. The Karolinska Institutet real-world study was a randomized, prospective, double-masked study comparing injection frequency between aflibercept and ranibizumab in patients with macular edema (ME) secondary to CRVO. All patients received 3 monthly loading doses, followed by subsequent injections extended by 2-week intervals to a maximum of 12 weeks as long as ME was absent.
- Visual outcomes in terms of mean change in BCVA from baseline in the entire cohort, ITT population (n=43). No significant difference between treatment groups.
- Hykin P, Prevost AT, Vasconcelos JC, et al; for the LEAVO study group. Clinical effectiveness of intravitreal therapy with ranibizumab vs aflibercept vs bevacizumab for macular edema secondary to central retinal vein occlusion. JAMA Ophthalmol. Published online first August 29, 2019. doi:10.1001/jamaophthalmol.2019.
- Boyer D, Heier J, Brown DM, et al. Vascular endothelial growth factor trap-eye for macular edema secondary to central retinal vein occlusion. Ophthalmology. 2012;119:1024-1032.
- Casselholm de Salles M, Amrén U, Kvanta A, Epstein DL. Injection frequency of aflibercept versus ranibizumab in a treat-and-extend regimen for central retinal vein occlusion: a randomized clinical trial. Retina. 2018:1-7. doi: 10.1097/IAE.0000000000002171.
- Heier JS, Clark WL, Boyer DS, et al. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS study. Ophthalmology. 2014;121:1414-1420.
- Papadopoulos N, Martin J, Ruan Q, et al. Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap, ranibizumab and bevacizumab. Angiogenesis. 2012;15;171-185.