Actively Recruiting // Age-related Macular Degeneration // Clinical Trials // Mihai Mititelu // Sep 28 2020

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

Study objective:

This study will assess the effectiveness and safety of high dose of aflibercept in participants with neovascular age-related macular degeneration (nAMD).

Study design:

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.