Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial.

ABSTRACT:

Aim

The prospective, noninterventional OCEAN study assessed the safety of intravitreal ranibizumab injections for treatment of neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion under real-world conditions in Germany.

Methods

Adults receiving ≥1 ranibizumab (0.5 mg) injections were recruited by 369 ophthalmologists and followed for 24 months. Information on adverse events (AEs) was reported by the treating physician or detected by the data management team. Collected information included observed AE, AE start and end date, intensity, causal relationship, outcome, severity, suspected drug, and actions taken.

Results

2,687 AEs were reported for 1,176 of the 5,781 patients who had received a total of 32,621 injections: 27.4% n

SUBMITTER: Ziemssen F 

PROVIDER: S-EPMC7558801 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature