Roche unit Genentech has now presented results from a second Phase III clinical trial aimed at broadening the scope of its sight drug Lucentis (ranibizumab injection) to address macula oedema due to retinal vein occlusion (RVO).

Results from the 12-month CRUISE trial were presented at the Retina Congress 2009 meeting in New York, US along with more detailed results from the BRAVO study, which Genentech reported on last July.

In both trials, RVO patients given either of two doses of Lucentis showed on average a clinically and statistically significant improvement in vision at six months compared with patients who received sham injections. The improvements were measured in terms of the primary endpoint for BRAVO and CRUISE, which was the mean change from baseline in best-corrected visual acuity (BCVA).

RVO occurs when there is a blockage to blood flow through a retinal vein, causing swelling (macular oedema) and haemorrhages in the retina. Sudden blurring or loss of vision in all or part of one eye are common in RVO, which has an age range from young adults to the elderly, Genentech noted.

The BRAVO and CRUISE trials concerned the two main types of RVO, branch and central respectively. Branch RVO, which affects an estimated 868,000 people in the US, is due to a blockage in one of the branches of the eye’s main vein. Central RVO, which affects some 259,000 people in the US, means the main vein of the eye, located at the optic nerve, is blocked.

The CRUISE study involved 392 patients with macular oedema secondary to central RVO. As with the BRAVO trial, there was a six-month, sham-controlled treatment period followed by a six-month observation period, during which all the participants were eligible to receive Lucentis as needed. In the initial six-month period, participants in both trials were given monthly injections of 0.3mg/0.5mg Lucentis or monthly sham injections.

At six months, 46.2% (61 out of 132) of the patients on 0.3mg Lucentis and 47.7% (62/132) of those on 0.5mg Lucentis had their vision improved by 15 letters or more on the study eye chart, compared with 16.9% (22/130) of the patients who received sham injections, Genentech reported.

A mean gain in BCVA was observed, starting at day seven with an 8.8- and a 9.3-letter improvement in the 0.3mg and the 0.5mg Lucentis arms respectively, compared with a 1.1-letter gain in the sham injection group.

The safety profile was consistent with that seen in previous Phase III studies of Lucentis for its marketed indication of wet (neovascular) age-related macular degeneration, Genentech said.