Study: quarterly dosing of ranibizumab may not be as effective as monthly dosing

Dr. Kaiser, affiliated with the Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, reported on the subgroup analysis of the first-year results of this phase 3b clinical trial of ranibizumab during the American Academy of Ophthalmology annual meeting here.

Patients (n = 184) with subfoveal CNV of any lesion composition were assigned randomly to ranibizumab at a dose of either 0.3 or 0.5 mg or sham treatment. They were treated with three monthly injections and then quarterly injections. The primary endpoint occurred at 12 months, he reported.

"The predominantly classic lesions were relatively well balanced [among the three groups], but there appeared to be more occult with no classic CNV in the rani-bizumab-treated patients compared with the minimally classic in the sham group," Dr. Kaiser said. The mean lesion size was about 4 DA.

PIER subgroup analyses

The PIER subgroup analyses showed the anti-VEGF therapy was effective in terms of patient baseline characteristics: age, race, baseline vision, and baseline lesion size. Dr. Kaiser noted that additional PIER subgroup analyses were undertaken to determine whether retinal thickness and fluorescein leakage at specific times during the study had any prognostic significance.

Optical coherence tomography (OCT) was used to determine foveal retinal thickness at three time points during the study: month 2, 3, and 5. Also, fluorescein angiography was used to indicate leakage at month 3 and 5.

"We wanted to see if these data could help us in the management of patients with ranibizumab," Dr. Kaiser said. "For these analyses, we pooled the data from 0.3- and 0.5-mg dosages of ranibizumab."