Dual Antagonism of PDGF and VEGF in Neovascular AMD in a Phase 2b Trial
By Marianne Doran and selected by George B. Bartley, MD
Journal Highlights
Ophthalmology, February 2017
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Jaffe et al. assessed the safety and efficacy of E10030 (Fovista), a platelet-derived growth factor (PDGF) antagonist administered in combination with anti-VEGF agent ranibizumab (Lucentis) in the treatment of neovascular age-related macular degeneration (nAMD). They found that the combination therapy demonstrated visual benefits compared with ranibizumab monotherapy.
This was a phase 2b multicenter superiority trial with a randomized prospective double-masked controlled design. The 449 participants withtreatment-naive subfoveal nAMD were randomized 1:1:1 to the following intravitreal treatment groups: E10030 0.3 mg in combination with ranibizumab 0.5 mg; E10030 1.5 mg in combination with ranibizumab 0.5 mg; and sham in combination with ranibizumab 0.5 mg. Drugs were administered monthly in each of the groups for a total treatment duration of 24 weeks.
The main outcome measure was a prespecified primary endpoint of mean change in visual acuity (VA; measured in EDTRS letters) from baseline to 24 weeks. The E10030 (1.5 mg) combination therapy regimen demonstrated superiority in mean VA gain compared with anti-VEGF monotherapy (10.6 ETDRS letters at week 24 vs. 6.5 ETDRS letters, respectively; p = .019). All clinically relevant treatment endpoints of visual benefit (≥15 ETDRS letters gained, final VA 20/40 or better) and visual loss (≥1 ETDRS line loss, ≥2 ETDRS line loss, and final VA 20/125 or worse) favored the E10030 (1.5 mg) combination group. A dose-response relationship was evident at each measured time point beginning at 4 weeks. The researchers found no significant safety issues in any treatment group.
The researchers concluded that there was a 62% relative benefit from baseline in the E10030 (1.5 mg) combination therapy group compared with the anti-VEGF monotherapy group.
The original article can be found here.