Clinical safety of ranibizumab in age-related macular degeneration.
BACKGROUND
Clinical safety of pharmaceutical products in the elderly is vital because of their increased risk of cardiac and other adverse events.


METHODS
Search of the Medline database, including articles and abstracts from 1984 to 2009.


RESULTS
Knowledge of ocular and systemic risks: The rate of endophthalmitis was 0.05% per injection (MARINA) and <0.1% per injection (ANCHOR), rates confirmed in a retrospective analysis of 14,320 injections. Moderate increases in intraocular pressure were transient, and incidences of intraocular inflammation were rarely serious. Systemic arterial thromboembolic events occurred in 4.6 and 0% of ranibizumab-treated patients and in 3.8 and 0% of sham-treated patients in MARINA (2 years) and PIER (1 year), respectively. In SAILOR, there was a numerically higher rate of cerebrovascular stroke with 0.5 mg ranibizumab compared with 0.3 mg ranibizumab (1.2 vs 0.7%), which was a non-statistically significant trend in patients with a history of stroke.


CONCLUSIONS
Although further studies to investigate the risk of stroke with ranibizumab therapy are required, repeated intravitreal ranibizumab was well tolerated and not associated with clinically significant safety risks during up to 2 years of treatment.
Schmidt-Erfurth
Ursula
U
Medical University of Vienna, Department of Ophthalmology, Waehringer Guertel 18-20, A-1090 Vienna, Austria. ursula.schmidt-erfurth@meduniwien.ac.at
D020533:Angiogenesis Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D020256:Choroidal Neovascularization / Q000150:complications / Q000188:drug therapy; D002986:Clinical Trials as Topic; D004359:Drug Therapy, Combination / Q000009:adverse effects; D009877:Endophthalmitis / Q000139:chemically induced; D005128:Eye Diseases / Q000139:chemically induced*; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008268:Macular Degeneration / Q000150:complications / Q000188:drug therapy*; D011166:Porphyrins / Q000008:administration & dosage / Q000009:adverse effects*; D000069579:Ranibizumab; D013923:Thromboembolism / Q000139:chemically induced; D000077362:Verteporfin
D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D011166:Porphyrins; D000077362:Verteporfin; D000069579:Ranibizumab