Lucentis: At 1 year, patients gained letters, few lost

MONTREAL — Almost one-third of patients treated with ranibizumab for age-related macular degeneration in a clinical trial gained 15 letters from baseline visual acuity at the 1 year follow-up mark, said Joan W. Miller, MD, speaking here at the American Society of Retina Specialists meeting.

Of 716 patients enrolled in the Minimally classic/occult trial of the Anti-VEGF antibody RhuFab V2 In the treatment of Neovascular AMD (MARINA) study, 252 were men.

The MARINA study is a phase 3, multicenter, randomized, double-masked, sham-injection-controlled study in subjects with subfoveal neovascular AMD. Patients in the trial were randomized to receive either 0.3 mg or 0.5 mg doses of Lucentis (ranibizumab, Genentech) or sham injection. The treatment schedule included monthly injections for 2 years, Dr. Miller noted. Photodynamic therapy could be administered at the investigator’s discretion if the lesion converted or the patient had lost visual acuity of 20 letters or more.

About one-third of the patients’ lesions were minimally classic, Dr. Miller said, and baseline visual acuity ranged from 20/40 to 20/320.

“The median vision was about 20/80, and the mean lesion size was just under 4.5 disc areas,” she said.

The primary endpoint of the trial was the proportion of subjects who at 12 months had lost fewer than 15 letters from baseline in best corrected visual acuity score on an eye chart.

“And indeed, 25% to 34% of subjects receiving ranibizumab achieved this important vision gain compared to only 5% in the sham group,” Dr. Miller said. “Of the subjects receiving ranibizumab, 39% to 40% achieved a vision of 20/40 or better at month 12, up from their baseline levels of 11% to 15%. In contrast, the sham group went from 15% to about 11% at month 12 with a vision of 20/40 or better.”

When looking at mean change in acuity over time, “we see a loss of about 10.5 letters in the sham group compared with a gain in the treatment groups of about seven letters, giving an overall treatment benefit of 17 letters or better,” Dr. Miller said.

No culture-positive cases of endophthalmitis were reported in the patients receiving ranibizumab, but there were three presumed culture-negative cases of endophthalmitis, she said. There were three cases of uveitis, two retinal tears, and two vitreous hemorrhages in the ranibizumab groups.