MARINA 2-year study results show positive treatment effect of ranibizumab

Ranibizumab (Lucentis, Genentech) for treatment of neovascular age-related macular degeneration (AMD) was shown to prevent moderate vision loss over 24 months and to result in improved vision in some patients in the MARINA Study, according to Joan Miller, MD, who reported the results during Retina Subspecialty Day.

Patients were randomly selected during the phase III, multicenter, randomized trial to sham treatment or one of two doses (0.3 or 0.5 mg) of ranibizumab and received monthly injections for 24 months.

"There was a significant benefit in the prevention of moderate vision loss at 12 and 24 months with ranibizumab compared with sham treatment," Dr. Miller reported. She is the Henry Willard Williams professor of ophthalmology, Harvard Medical School, and chief and chairwoman of ophthalmology, Massachusetts Eye & Ear Infirmary, Boston.

"In addition, about one-third of the patients treated with ranibizumab gained three or more lines of vision compared with 5% of the patients who received sham treatment at month 12," Dr. Miller said. "This benefit of ranibizumab was the same through month 24. There was also an improvement in the mean visual acuity in the ranibizumab groups compared to a loss of mean visual acuity in the sham-treated group."

Time course analysis indicated that the proportion of patients who received sham treatment and avoided moderate vision loss decreased steadily with time, while the great majority of patients treated with ranibizumab avoided a three-line vision loss over 24 months. Few sham-treated patients gained three or more lines of vision over 24 months. However, the proportion of patients treated with ranibizumab who gained three or more lines of vision increased through month 12 and then remained steady to month 24, Dr. Miller reported.

The safety profile of the drug remained excellent through the 24 months of the trial.

"A visual acuity benefit was evident as early as 1 month after treatment with ranibizumab and increased over time to 12 months," she concluded. "The benefit at 12 months on average was maintained throughout the 24 months of the study."