Examining 1-year LUCAS Study results for AMD treatments

Oslo, Norway-The 1-year results of the inject-and-extend Lucentis Compared to Avastin Study (Lucas) for exudative age-related macular degeneration (AMD) indicated that the two drugs have equivalent effectiveness, said Karina Berg, MD.

“This is the first study of the drugs using an inject-and-extend protocol,” said Dr. Berg, Department of Ophthalmology, Oslo University Hospital, Oslo.

The prospective, randomized, double-blind, multicenter, non-inferiority trial included 432 patients with active choroidal neovascularization and edema involving the fovea. The best-corrected visual acuity (VA) levels ranged from 20/25 to 20/320.

The patients were randomly assigned to either ranibizumab (Lucentis, Genentech) or bevacizumab (Avastin, Genentech). Both groups were well matched at baseline for sex, age, VA, and retinal thickness.

The protocol required that patients receive an injection of ranibizumab or bevacizumab once every 4 weeks until the macula became dry. The treatment interval was then extended by 2 weeks up to 12 weeks. With a recurrence, the treatment interval was reduced by 2 weeks until the macula dried. Eighty-six percent of patients completed the 1-year examination, according to Dr. Berg.

She reported that the VA scores increased significantly in both treatment groups. The mean changes in the VA scores from baseline were 8.2 letters in the ranibizumab group and 8 letters in the bevacizumab group. These results were achieved with a mean of 8 injections in the ranibizumab group and a mean of 8.8 injections in the bevacizumab group. The difference in the number of injections reached significance (p = 0.002).

The mean retinal thickness also decreased significantly in both groups by 120 and 109 µm, respectively.

Some serious adverse effects were reported at 1 year, with 10 arteriothrombotic events in the ranibizumab group and three in the bevacizumab group. One case of pseudoendophthalmitis developed in the bevacizumab group.

“At 1 year, (both drugs) had equivalent effects on VA when administered according to an inject-and-extend protocol,” Dr. Berg said. “There was a small but significant difference in the number of required injections, favoring (ranibizumab). The numbers of reported serious events were small.”

The study will continue out to 2 years.