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Clinical safety of ranibizumab in age-related macular degeneration
1Medical University of Vienna, Department of Ophthalmology, Waehringer Guertel 18-20, A-1090 Vienna, Austria. ursula.schmidt-erfurth@meduniwien.ac.at
Importance Of The Field:
Clinical safety of pharmaceutical products in the elderly is vital because of their increased risk of cardiac and other adverse events.
Areas Covered In This Review:
Search of the Medline database, including articles and abstracts from 1984 to 2009.
What The Reader Will Gain:
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.
Take Home Message:
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.
Insights
Repeated intravitreal ranibizumab injections showed good tolerability in patients, with no significant safety risks observed over two years. Further research is needed to fully understand potential stroke risks associated with ranibizumab therapy.
Area of Science:
- Ophthalmology
- Pharmacology
Background:
- Elderly patients face higher risks for cardiac and other adverse events from pharmaceutical products.
- Ensuring clinical safety in this demographic is crucial.
Purpose of the Study:
- To review the clinical safety of pharmaceutical products in the elderly.
- To assess ocular and systemic risks associated with ranibizumab therapy.
Main Methods:
- A comprehensive search of the Medline database was conducted.
- Articles and abstracts published from 1984 to 2009 were included.
Main Results:
- Endophthalmitis rates were low (0.05%-0.1% per injection).
- Transient, moderate intraocular pressure increases and rare serious inflammation were noted.
- Systemic thromboembolic events showed no significant difference between ranibizumab and sham treatments, though a non-significant trend for stroke was observed in some patient groups.
Conclusions:
- Repeated intravitreal ranibizumab demonstrated good tolerability and no clinically significant safety risks up to two years.
- Further investigation into the stroke risk with ranibizumab therapy is warranted.
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