[視網膜] 以采視明治療 非增值性糖尿病視網膜病變(NPDR)

本研究為Intravitreal Aflibercept for Moderately Severe to Severe Non-Proliferative Diabetic Retinopathy (NPDR) The Phase 3 PANORAMA Study
官方powrepoint連結: https://tinyurl.com/u6pt8eu

第一年成果 官方新聞稿:https://tinyurl.com/uqoqdu9
PANORAMA 是一個雙盲、隨機分配的兩年追蹤，以采視明治療無黃斑水腫的中重度到重度 非增值性糖尿病視網膜病變(NPDR)。

對照組為假藥注射。(sham injections)
第一組:連三針月注射、隔兩個月第四針、之後四個月一針
第二組:連五針月注射、之後兩個月一針、一年之後可調整

成效指標: DRSS、增殖性糖尿病視網膜病變、前房新生血管、黃斑水腫、視力


NASDAQ: REGN) today announced that the Phase 3 PANORAMA trial evaluating EYLEA® (aflibercept) Injection in patients with moderately severe and severe non-proliferative diabetic retinopathy (NPDR) met its one-year (52-week) primary endpoint and key secondary endpoints. On the primary endpoint at one year, 80% and 65% of patients receiving EYLEA on an every 8- and every 16-week interval (after an initial monthly dosing period), respectively, experienced a two-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale, compared to 15% of patients receiving sham injection (p<0.0001). Regarding the two key secondary endpoints, which achieved statistical significance based on the pre-specified hierarchical analysis, treatment with EYLEA also reduced vision-threatening complications (VTCs) by 82%-85% and the development of center-involved diabetic macular edema (CI-DME) by 68%-74% compared with sham injection.

The development of VTCs (proliferative diabetic retinopathy and anterior segment neovascularization) was 3% for the EYLEA every 8-week group, 4% for the EYLEA every 16-week group, and 20% for the sham injection group (p<0.001).
CI-DME occurred in 8% of the EYLEA every 8-week group, 7% of the EYLEA every 16-week group, and 26% of the sham injection group (p<0.001).
These events collectively occurred in 11% and 10% of patients receiving EYLEA every 8 weeks or every 16 weeks, respectively, compared to 41% of patients receiving sham injection (p<0.001).
"Blindness caused by diabetes is one of the most feared consequences of this disease," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "In this trial of patients with diabetic eye disease and normal vision, it is notable that without treatment more than one third of patients developed a vision-threatening complication or diabetic macular edema within one year. EYLEA was able to reduce these complications by 68%-85% even with every four-month dosing, and moreover was able to reverse the anatomic severity of the disease. These results point to the potential value of earlier intervention in diabetic retinopathy and may in the future change the way retina specialists treat this disease."

The average number of injections in the first year was 8.6 (of 9 planned) for the EYLEA every 8-week group and 5.5 (of 6 planned) for the EYLEA every 16-week group.


Adverse events were consistent with the known profile of EYLEA. Serious ocular treatment-emergent adverse events in the study eye occurred in 0 and 1 patients in the EYLEA treatment groups and 1 patient in the sham injection group. Ocular inflammation occurred in 1 patient in each EYLEA treatment group and 0 patients in the sham injection group. Anti-Platelet Trialists' Collaboration (APTC)-defined arterial thromboembolic treatment-emergent events occurred in 4 and 2 patients in the EYLEA treatment groups and 5 patients in the sham injection group.