Category: Clinical

Month: 04 Dec 2016

Issue: not yet available

Phase IIb study of a combination therapy, comprising anti-PDGF and anti-VEGF treatments, show a 62% relative benefit over monotherapy alone

Results of a Phase IIb clinical study, published in the American Journal of Ophthalmology (Ophthalmology, in press), report a 62% relative benefit for the combined use of 1.5 mg “E10030”, an antagonist of platelet derived growth factor (PDGF), and anti-VEGF agent in the treatment of neovascular AMD. The study, sponsored by Ophthotech Corporation, additionally reports a favourable safety and efficacy profile for the combination therapy, a regimen which may be of particular interest to patients not responding well to anti-VFGF monotherapy. The authors of the study suggest that a combination therapy for wet AMD may be of benefit to the estimated 18% to 22% of patients who lose visual acuity in their first year of treatment, and of benefit to the estimated 50% of patients who do not achieve 20/40 or better visual acuity, a standard required for an unrestricted driver’s license in some US states.

 

The study, officially entitled, “A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration, enrolled 449 subjects across 69 study centres in 9 different countries in North and South America, Europe and Israel. The study population was randomly allocated into three separate treatment groups, 1:1:1, with about 148 patients in each group. In the first cohort, patients received 0.3 mg of E10030 in combination with 0.5 mg ranibizumab, the second group received 1.5 mg E10030 in combination with 0.5 mg ranibizumab, while the final group received a sham in combination with 0.5 mg ranibizumab (i.e., anti-VEGF monotherapy). All medication was administered monthly in each patient cohort for a total duration of 24 weeks.

 

The primary end point for the study was the mean change in visual acuity from baseline at the 24-week time point. According to the study results, the 1.5mg E10030 combination therapy met the primary end point of superiority in mean visual acuity gain compared with the anti-VEGF monotherapy alone. The results showed that the 1.5mg E10030 group had a mean of 10.6 compared with 6.5 ETDRS letters at week (P=0.019). Analysis of interim timepoints showed a dose-response relationship with E10030 commencing at 4 weeks. In addition, the study indicated that visual acuity outcomes appeared more favourable for the 1.5mg E10030 combination therapy group independent of their visual acuity recording at baseline and independent of lesion size and central subfield thickness on optical coherence tomography. The study presents an encouraging Phase II result however, the study population used in the trial represent a treatment-naïve patient group. Subsequent studies with other relevant population groups may be instructive, particularly in regard to patients not responding well to anti-VEGF treatments alone.

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