Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration (Pulsar)
Sponsor: Bayer AG
Principal Investigator: Mihai Mititelu, MD, MPH
Study Coordinator: Angie Adler
This study will assess the effectiveness and safety of high dose of aflibercept in participants with neovascular age-related macular degeneration (nAMD).
Patients will be randomly assigned to one out of three study treatment groups. The study will compare high dose aflibercept administered every 12 or every 16 weeks, after 3 initial injections at 4-week intervals versus aflibercept 2 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.
Diagnosis and Key Eligibility Criteria:
At least 50 years of age with active subfoveal choroidal neovascular lesion (CNV) secondary to nAMD, greater than 50% of the total lesion area in the study eye and a Snellen score of approximately 20/32 to 20/320 in the study eye
Patients cannot have had any previous treatment with any anti-VEGF therapy or vitreoretinal surgery in the study eye at any time prior to baseline
Patients may have had investigational therapy but require a washout period of 30 days in the study eye and 180 days in the fellow eye before screening
Prior treatment in the fellow eye with approved anti-VEGF therapy is allowed
Duration of study: Approximately 22 months.
For more information, contact Angie Adler 608-265-7557.