MyVisionTest News Archive
Nov 23, 2008
Meta-analysis confirms Lucentis safety
Lucentis (ranibizumab) appears safe in the treatment of wet age-related macular degeneration (AMD), according to an analysis of 4 large clinical trials.
Dr David Boyer presented these findings at the 2008 Joint Meeting of the American Academy of Ophthalmology (AAO) and the European Society of Ophthalmology (SOE).
Several clinical trials have evaluated the safety of Lucentis using differing dosing and treatment schedules. In the current analysis, Dr Boyer analyzed data from the MARINA, ANCHOR, PIER, and SAILOR trials, including 3701 patients receiving a total of 28,547 Lucentis injections. Trials were 2 years in duration, with the exception of the SAILOR trial cohort 1, which was 1 year in duration. Dr. Boyer and colleagues assessed safety outcomes, including the incidence of ocular and nonocular adverse events.
Incidence of intraocular inflammation was somewhat higher for Lucentis-treated patients compared with the sham or photodynamic therapy, respectively, in the MARINA (15.9% vs 10.6%) and ANCHOR trials (14.4% vs 3.5%).
The rates of serious endophthalmitis per injection was very low, ranging from 0% to 0.06% for 2 years of treatment with Lucentis compared with 0% in patients in the control groups.
In the Lucentis group vs control group, respectively, the incidence of cataracts per patient was comparable in the MARINA trial, 15.5% vs 15.7%, but was higher with Lucentis in the other trials: 18.4% vs 10.5% in the ANCHOR trial and 13.3% vs 8.1% in the PIER trial. Incidence of cataracts was 5.7% in the 1 year SAILOR trial.
For nonocular adverse events, the rate of blood clots was 2.7% after year 1 in all 4 studies combined and 4.1% after year 2 in 3 studies combined.
In addition, there was a non-significant difference towards a higher rate of stroke in the Lucentis group vs the control group, whereas no such trend was observed for heart attack or arterial thrombotic events overall.
Dr Boyer said, "In my opinion, the only new finding from the analysis was that it showed a higher rate of ocular inflammation in the ranibizumab treated patients treated monthly in the 2-year MARINA and ANCHOR trial vs the 1 year SAILOR cohort 1."
"There are no safety signals that should deter physicians from using ranibizumab for patients with neovascular AMD," Dr Diana Do, of Johns Hopkins University, said.
Read more...
Medscape
Tags: wet AMD, Lucentis, clinical trial
Lucentis (ranibizumab) appears safe in the treatment of wet age-related macular degeneration (AMD), according to an analysis of 4 large clinical trials. Dr David Boyer presented these findings at the 2008 Joint Meeting of the American Academy of Ophthalmology (AAO) and the European Society of Ophthalmology (SOE).
Incidence of intraocular inflammation was somewhat higher for Lucentis-treated patients compared with the sham or photodynamic therapy, respectively, in the MARINA (15.9% vs 10.6%) and ANCHOR trials (14.4% vs 3.5%).
The rates of serious endophthalmitis per injection was very low, ranging from 0% to 0.06% for 2 years of treatment with Lucentis compared with 0% in patients in the control groups.
In the Lucentis group vs control group, respectively, the incidence of cataracts per patient was comparable in the MARINA trial, 15.5% vs 15.7%, but was higher with Lucentis in the other trials: 18.4% vs 10.5% in the ANCHOR trial and 13.3% vs 8.1% in the PIER trial. Incidence of cataracts was 5.7% in the 1 year SAILOR trial.
For nonocular adverse events, the rate of blood clots was 2.7% after year 1 in all 4 studies combined and 4.1% after year 2 in 3 studies combined.
In addition, there was a non-significant difference towards a higher rate of stroke in the Lucentis group vs the control group, whereas no such trend was observed for heart attack or arterial thrombotic events overall.
Dr Boyer said, "In my opinion, the only new finding from the analysis was that it showed a higher rate of ocular inflammation in the ranibizumab treated patients treated monthly in the 2-year MARINA and ANCHOR trial vs the 1 year SAILOR cohort 1."
"There are no safety signals that should deter physicians from using ranibizumab for patients with neovascular AMD," Dr Diana Do, of Johns Hopkins University, said.
Read more...
Medscape
