Data analyses collected in a phase III clinical trial show a strong benefit of intravitreal ranibizumab for clearing macular edema and rehabilitating vision in patients who have suffered a branch retinal vein occlusion.
New York-Analyses of data collected through 6 months in a phase III clinical trial show a strong benefit of intravitreal ranibizumab (Lucentis, Genentech) for clearing macular edema (ME) and rehabilitating vision in patients who have suffered a branch retinal vein occlusion (BRVO), said Peter A. Campochiaro, MD, at the 2009 Retina Congress.
Patients received their assigned study medication at baseline and at monthly intervals through 6 months. Rescue laser treatment was allowed for any patient meeting protocol-specified criteria for an insufficient response to study medication.
Change in BCVA from baseline to 6 months was the primary efficacy endpoint. At 1 week after the first injection, both ranibizumab groups exhibited a mean BCVA improvement of about 7.5 letters, and there was a gradual increase thereafter so that at 6 months mean BCVA gains in the ranibizumab 0.3 and 0.5 mg groups were 16.6 and 18.3 letters, respectively. Mean BCVA improvement in the sham group was less than 2 letters at 1 week and 7.3 letters at 6 months.
The 6-month data from BRAVO and CRUISE, a parallel-running pivotal trial investigating ranibizumab for the treatment of central RVO, will be included in a supplemental biologics license application that Genentech plans to submit to the FDA for Lucentis in RVO in early 2010.
"The rapid and sustained benefit of ranibizumab for restoring vision in patients with ME secondary to BRVO, at least to 6 months, is very impressive, and we hope the results of these pivotal trials will be the basis for FDA approval," said Dr. Campochiaro. "Then, I would expect that ranibizumab will be considered first-line treatment for this condition, whether or not patients would be considered candidates for laser therapy."
At baseline, the three study groups were balanced with respect to demographic characteristics and mean BCVA (~20/80). Mean foveal thickness measured by OCT was slightly greater in the ranibizumab 0.3 and 0.5 mg groups compared with controls, 522 and 551 versus 488 µm, respectively. Mean duration between the BRVO episode and study entry was 3.5 months in all groups.
"There was a tendency for patients who received treatment earlier, within 3 months of baseline, to do a little bit better in terms of regaining vision compared with those who entered the study between 3 and 12 months after their event," Dr. Campochiaro said. "However, the vast majority of patients [showed improvement] regardless of the interval to treatment initiation."
BCVA data were also analyzed to determine the percentages of patients who achieved a gain of 15 letters or greater, 20/40 or better vision, and lost less than 15 letters; for all of these secondary efficacy endpoints, there were statistically significant differences beginning at 1 week and persisting to 6 months that favored both ranibizumab groups versus controls.
At 6 months, at least twice as many patients treated with ranibizumab 0.3 and 0.5 mg achieved a clinically significant improvement in BCVA (gain of 3 lines or more), 55.2% and 61.1% versus 28.8%, respectively. The rate of attainment of BCVA of 20/40 or better, e.g., reading or driving vision, was about 1.5-fold higher in the ranibizumab 0.3 mg and 0.5 mg groups compared with controls, 67.9% and 64.9% versus 41.7%, respectively.