A single-masked Phase I/II clinical study of the investigational drug Lucentis ( Ranibizumab ) met its primary efficacy endpoint of maintaining vision in patients with wet age-related macular degeneration ( AMD ) when used in combination with Verteporfin ( Visudyne ) photodynamic therapy ( PDT ).
Approximately 90 percent of patients maintained or improved vision ( defined as a loss of less than 15 letters in visual acuity ) when treated with the combination of Lucentis and PDT compared to approximately 68 percent of those treated in the control arm of PDT alone ( p = 0.0003 ).
Patients treated with Lucentis plus PDT at 12 months had, on average, a significant improvement in visual acuity compared to visual acuity at study entry, an important secondary endpoint, while the PDT-alone group demonstrated a decrease in mean visual acuity from baseline to 12 months.
A preliminary analysis of the data showed there was an increased risk of the serious ocular adverse event uveitis in patients treated with Lucentis in combination with PDT compared to patients treated with PDT alone.
An amendment to the study protocol was made after data safety monitoring identified this imbalance. After uveitis, endophthalmitis was the second most common ocular serious adverse event occurring in patients treated with Lucentis.
Among non-ocular serious adverse events, the frequency of cerebral vascular events was slightly higher in those treated with Lucentis, while the frequency of myocardial infarctions was slightly higher in the PDT-alone arm. In both cases, the difference between groups was not statistically significant.
Genentech and Novartis Pharma recently announced top-line positive results from the Phase III MARINA study.
A preliminary analysis of the MARINA data showed that adverse events were similar to those seen in earlier trials of Lucentis.
Common side effects occurring in the Lucentis arms more frequently than in the control group were mild to moderate and included conjunctival hemorrhage, eye pain and vitreous floaters.
Serious ocular adverse events occurring more frequently in Lucentis-treated patients were rare (