A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema
A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema
The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.
The secondary objectives of the study are as follows:
Key Inclusion Criteria:
Extension Phase: All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment.
Key Exclusion Criteria:
NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
North York, Ontario M3C 0G9, Canada
Yoshida-Gun, Fukui 910-1193, Japan
Tsuchiura-shi, Ibaraki 300-0817, Japan
Kita-gun, Kagawa-ken 761-0793, Japan
Shimotsuke-shi, Tochigi 329-0498, Japan
Chiyoda-ku, Tokyo 101-8309, Japan
Itabashi-ku, Tokyo 173-0015, Japan
Meguro-ku, Tokyo 152-8902, Japan