Safety of Pegaptanib Sodium for Eye Disease
Author Information
Author(s): Singerman L J, Masonson H, Patel M, Adamis A P, Buggage R, Cunningham E, Goldbaum M, Katz B, Guyer D
Primary Institution: Retina Associates of Cleveland
Hypothesis
To evaluate the safety of up to 3 years of pegaptanib sodium therapy in the treatment of neovascular age-related macular degeneration (NV-AMD).
Conclusion
The 3-year safety profile of pegaptanib sodium was favourable in patients with NV-AMD.
Supporting Evidence
- Pegaptanib was well tolerated in year 3.
- Adverse events were mainly ocular in nature, mild, transient and injection-related.
- Serious adverse events were rare.
- No evidence of systemic safety signals attributed to VEGF inhibition arose in year 3.
Takeaway
This study looked at how safe a medicine called pegaptanib is for treating eye problems over three years, and it found that it was mostly safe.
Methodology
Two concurrent, prospective, multicentre, double-masked studies randomised subjects to receive intravitreous pegaptanib sodium or sham injections every 6 weeks for 54 weeks, with follow-up for 3 years.
Potential Biases
None reported.
Limitations
Statistical analyses on year 3 data were limited by small sample sizes and were considered to be descriptive.
Participant Demographics
Predominantly white, higher ratio of females to males, mean age in the mid-70s.
Statistical Information
P-Value
0.06
Statistical Significance
p<0.0001
Digital Object Identifier (DOI)
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