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Antiplatelet-derived growth factor with ranibizumab shows promise for neovascular AMD
CHICAGO – An antiplatelet-derived growth factor combined with ranibizumab outperformed ranibizumab monotherapy in treating neovascular age-related macular degeneration, a speaker said here.
“If these results are confirmed in a larger pivotal trial, it has the potential to dramatically and profoundly change our treatment model for patients with neovascular macular degeneration,” OSN Retina/Vitreous Board Member Pravin U. Dugel, MD, said during Retina Subspecialty Day preceding the joint meeting of the American Academy of Ophthalmology and Asia Pacific Academy of Ophthalmology.
Dugel presented results of a prospective randomized phase 2 clinical trial comparing Fovista (Ophthotech) combined with ranibizmab (Lucentis, Genentech) and ranibizumab alone.
The study included 449 patients who received PDGF 0.3 mg in combination with ranibizumab 0.5 mg, PDGF 1.5 mg in combination with ranibizumab 0.5 mg or sham injection in conjunction with ranibizumab 0.5 mg. Injections were administered every 4 weeks for 24 weeks.
Both combination treatment arms met the pre-specified primary endpoint of superiority. Each combination arm showed a 62% improvement in efficacy. Combination treatment was superior despite lesion size, Dugel said.
Additionally, visual improvement was greater in the combinaton therapy groups, Dugel said.
The study was the largest phase 2 superiority trial to have ever been done in retina, Dugel said.
Phase 1 trials showed a high safety profile for PDGF, Dugel said, adding that further study may support the phase 2 superiority study results.
“If these results are confirmed in a larger pivotal trial, it has the potential to dramatically and profoundly change our treatment model for patients with neovascular macular degeneration,” Dugel said.
Disclosure: Dugel is a minor shareholder in Ophthotech.