Ranibizumab associated with smaller changes in CNV areas versus sham injection in AMD patients

April 29, 2008

The dosing regimen of ranibizumab (Lucentis, Genetech) used in the PIER study demonstrated smaller changes in areas of choroidal neovascularization (CNV) compared with sham injection at 24 months in patients with neovascular age-related macular degeneration, said Mark Michels, MD, who discussed 2-year angiographic results of the study on behalf of all of the investigators.

The dosing regimen of ranibizumab (Lucentis, Genentech) used in the PIER study demonstratedsmaller changes in areas of choroidal neovascularization (CNV) compared with sham injection at 24 months inpatients with neovascular age-related macular degeneration, said Mark Michels, MD, who discussed 2-yearangiographic results of the study on behalf of all of the investigators.

"Change in the area of classic CNV at month 12 was not associated with change in visual status at month 24,"said Dr. Michels, of Retina Care Specialists, Palm Beach Gardens, FL. Neither was change in area of lesion at 12months related to change in visual status at 24 months, he added.

In the phase IIIb, 2-year, multicenter, double-masked trial, 184 patients were randomly assigned to receiveeither 0.3 or 0.5 mg of ranibizumab or sham injection. Patients received three monthly doses and then 10injections on a quarterly basis. Those who received sham treatment crossed over to 0.5 mg ranibizumab in thesecond year.

The primary endpoint of the study was mean change from baseline visual acuity at year 1. Fundus photography andfluorescein angiography were performed at baseline and 3, 5, 8, 12, and 24 months.

The researchers are continuing to evaluate the relationship between visual acuity and the anatomic changes oflesions.