Update on Lucentis clinical trials for retinal vein occlusion Genentech, Inc. announced results from two Phase III studies of Lucentis (ranibizumab) in macular edema due to retinal vein occlusion (RVO), which showed patients given Lucentis had significant improvement in best-corrected visual acuity (BCVA) at six months compared to patients receiving sham injections. Results from both trials were presented at the Retina Congress 2009 meeting.

Both BRAVO and CRUISE are 12-month studies consisting of a six-month, sham-controlled treatment period, followed by a six-month observation period (during which all participants are eligible to receive Lucentis as needed). During the first six-month period, participants in both trials received monthly injections of either 0.3 mg or 0.5 mg of Lucentis (n=265) or monthly sham injections (n=132). In the BRAVO study, all participants who met pre-specified criteria were eligible to receive rescue laser treatment during the first six-month period. The primary endpoint for both trials is the mean change from baseline in best-corrected visual acuity score at six months compared to sham.

BRAVO Clinical Trial

BRAVO is a multicenter, randomized, double-masked, sham injection-controlled Phase III study of 397 patients designed to assess the safety and efficacy profile of Lucentis in macular edema secondary to branch-RVO. Results at six months include:

• 55.2 percent (74/134) of patients who received 0.3 mg of Lucentis and 61.1 percent (80/131) who received 0.5 mg of Lucentis had their vision improved by 15 letters or more on the study eye chart (compared to 28.8 percent (38/132) of patients receiving sham injections).
• Mean gain in BCVA was observed beginning at day seven with a 7.6 and 7.4 letter gain in the 0.3 mg and 0.5 mg study arms of Lucentis, respectively (compared with 1.9 letters in the sham injection arm).

CRUISE Clinical Trial

CRUISE is a multicenter, randomized, double-masked, sham injection - controlled Phase III study designed to assess the safety and efficacy profile of Lucentis. The study includes 392 patients with macular edema secondary to central-RVO and at six months showed:

• 46.2 percent (61/132) of patients given 0.3 mg of Lucentis and 47.7 percent (62/130) given 0.5 mg of Lucentis had their vision improved by 15 letters or more (compared to 16.9 percent (22/130) of patients receiving sham injections).
• Mean gain in BCVA was observed beginning at day seven with an 8.8 and 9.3 letter gain in the 0.3 mg and 0.5 mg study arms of Lucentis, respectively (compared with 1.1 letters in the sham injection arm).

An analysis of the six-month data from both studies showed a safety profile consistent with previous Lucentis Phase III trials in wet age-related macular degeneration (AMD).

"RVO can lead to sudden loss of vision for which there are few treatment options," said Hal Barron, executive vice president of Genentech. "As early as seven days after their first injection, patients who received monthly injections of Lucentis had, on average, a statistically significant improvement in their vision that lasted through six months."

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