12-month results of two ranibizumab trials show promise

October 14, 2005

The 12-month results of two randomized clinical trials of ranibizumab (Lucentis, Genentech) indicate that the drug shows encouraging signs of activity against vascular endothelial growth factor (VEGF) in age-related macular degeneration (AMD), reported Jeffrey Heier, MD, Friday at the retina subspecialty day at the American Academy of Ophthalmology

Chicago-The 12-month results of two randomized clinical trials of ranibizumab (Lucentis, Genentech) indicate that the drug shows encouraging signs of activity against vascular endothelial growth factor (VEGF) in age-related macular degeneration (AMD), reported Jeffrey Heier, MD, Friday at the retina subspecialty day at the American Academy of Ophthalmology.

The RhuFab V Ocular Treatment Combining the Use of Visudyne to Evaluate Safety Study (FOCUS) is a phase I/II trial of the safety, tolerability, and efficacy of ranibizumab (0.5 mg) combined with photodynamic therapy (PDT) (verteporfin; Visudyne, Novartis/QLT) compared with PDT alone in patients with subfoveal predominantly classic choroidal neovascularization in AMD. All patients received PDT and were then randomized to ranibizumab (0.3 or 0 mg) injections or sham injection for 24 injections over 2 years.

“The 12-month results indicated that over 90% of the patients who received combination therapy reached the primary study endpoint of loss of fewer than 15 letters of visual acuity compared with 68% of patients who received PDT alone,” said Dr. Heier, clinical instructor in ophthalmology, Tuft School of Medicine and Harvard Medical School, Boston.

Importantly, 24% of the patients who received combination therapy had an improvement of three or more lines of vision versus 5% of those who received PDT alone.

The Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular AMD (MARINA) Study is a phase III trial of patients with subfoveal minimally classic/occult choroidal neovascularization secondary to AMD. Patients received either sham injections or ranibizumab (0.3 or 0.5 mg) injections for 24 treatments over 2 years. The 12-month results indicated that “there was a dramatic difference between the ranibizumab patients, 95% of whom lost fewer than 15 letters of vision compared with about 62% of the control patients,” Dr. Heier reported.

“Patients who received ranibizumab were far less likely to loss vision and far more likely to gain vision. There was a low rate of serious ocular adverse events and no apparent safety concerns,” he said.