Combination therapy offers improved visual outcome compared with anti-VEGF monotherapy, trial finds
Use of a novel anti-platelet-derived growth factor therapy in concert with ranibizumab resulted in a statistically significant improvement in visual outcome vs. ranibizumab monotherapy for the treatment of wet age-related macular degeneration, according to a press release from Ophthotech.
Patients in a phase 2b clinical trial who received a combination of 1.5 mg of Ophthotech’s anti-PDGF aptamer Fovista, formerly known as E10030, along with 0.5 mg of Lucentis (ranibizumab, Genentech) gained a mean of 10.6 letters of vision on the ETDRS standardized chart at 24 weeks, a 62% improvement over the 6.5-letter gain from ranibizumab monotherapy (P = .019).
“These study results show inhibition of PDGF is no longer a theoretical concept,” OSN Retina Medical Editor Carmen A. Puliafito, MD, MBA, told Ocular Surgery News in an interview.
“We have practical clinical results that suggest that, in combination with anti-VEGF therapy, [anti-PDGF] might offer some additional benefit,” he said.
The prospective, controlled trial randomized 449 patients with wet AMD into three groups, each receiving one of three treatments every 4 weeks for 24 weeks: Fovista 0.3 mg combined with ranibizumab 0.5 mg; Fovista 1.5 mg combined with ranibizumab 0.5 mg; or sham combined with ranibizumab 0.5 mg.
Fovista 1.5 mg with ranibizumab demonstrated improved visual outcomes at every monthly time point compared with ranibizumab monotherapy, according to the release. The improvement from combination therapy was greater at 6 months than it was at 3 months.
No significant safety issues were observed in the trial.
“When you inject anti-VEGF agents monthly, the visual acuity results are essentially equivalent,” Puliafito said. This study suggests that adding another agent may improve the visual result.
“That is the hypothesis that needs to be tested in a phase 3 clinical trial,” he said.
Study investigator Pravin U. Dugel, MD, told OSN, “This combination treatment has the potential of giving us a truly sustainable combination treatment model that not only gives us better visual acuity results, in an unheard of improved efficacy of 62% better efficacy than Lucentis alone, but the combination model also has the potential to eradicate the neovascular complex. In that sense, it is an absolute paradigm shift.”
RELATED: Read "Anti-PDGF, anti-VEGF combination may be game changer in wet AMD treatment" by Pravin U. Dugel, MD