Figure 19.1 The percentage of patients who avoided severe visual loss (defined as loss of ≥15 ETDRS letters) was not different among the four treatment arms (ranibizumab 0.5 mg every 4 weeks [Rbz0.5q4]; VEGF Trap-Eye 0.5 mg every 4 weeks [VTE0.5q4]; VEGF Trap-Eye 2 mg every 4 weeks [VTE2q4]; VEGF Trap-Eye 2 mg every 8 weeks [VTE2q8]).
Figure 19.2 The percentage of patients who gained ≥15 ETDRS at 52 weeks was not different among the four treatment arms (abbreviations as in Fig. 19.1).
Rates of adverse effects including endophthalmitis were not different among the treatment groups. There were three cases of injection-related endophthalmitis among the eyes treated with ranibizumab and three cases of endophthalmitis among the eyes randomized to VEGF Trap-Eye. Rates of systemic complications including vascular death, stroke, and myocardial infarction were low (approximately 1%–2% rate of arteriothrombotic events) and were not different among the four treatment arms. There did not appear to be any unexpected ocular or systemic safety concerns with VEGF Trap-Eye.
The VIEW 1 and 2 studies demonstrated that all doses and dosing regimens of VEGF Trap-Eye were equivalent to every 4-week dosing of ranibizumab, with comparable ocular and systemic safety profiles. These results are promising and may change the standard of care for neovascular AMD.
Although diabetes is not covered in the scope of this text, it should be mentioned that VEGF Trap-Eye has also undergone rigorous investigation for the treatment of diabetic macular edema. The DA VINCI (DME and VEGF Trap Eye: Investigation of Clinical Impact) (11