Update on Lucentis clinical trials for retinal vein occlusion

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Oct 26, 2009, 8:22:51 PM10/26/09

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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.

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."

Medical News Today

http://www.medicalnewstoday.com/articles/166319.php

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