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Thomas A Ciulla, Glenn J Jaffe, Samir Patel; Assessment of Retinal Pigment Epithelium (RPE) Atrophy in a Phase 2b Study of a Platelet Derived Growth Factor inhibitor (Fovista®), in combination with a Vascular Endothelial Growth Factor inhibitor (Ranibizumab) for Neovascular Age-Related Macular Degeneration (NAMD).. Invest. Ophthalmol. Vis. Sci. 2016;57(12):4418.
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© ARVO (1962-2015); The Authors (2016-present)
In several large NAMD randomized controlled trials (RCT), there is an increased risk of developing new geographic atrophy with monthly compared to discontinuous intravitreal vascular endothelial growth factor (VEGF) inhibition. Herein, we describe the occurrence of RPE atrophy over 24 weeks in the Phase 2b Study of Fovista®, a platelet derived growth factor (PDGF) inhibitor in combination with a VEGF inhibitor for NAMD.
449 patients with NAMD were randomized in a prospective, controlled, superiority trial to receive one of the following treatment regimens every 4 weeks for 24 weeks: Fovista® 0.3 mg with ranibizumab 0.5 mg; Fovista® 1.5 mg with ranibizumab 0.5 mg; or sham with ranibizumab 0.5 mg. OCT, fundus photographic, and fluorescein angiographic images were evaluated by readers masked to treatment assignment at a centralized reading center.
The combination of Fovista® (1.5 mg) with ranibizumab met the pre-specified primary endpoint of mean visual acuity gain superiority compared to ranibizumab monotherapy (10.6 ETDRS letters at week 24, compared to 6.5 letters, p=0.019). On OCT, fundus photography and fluorescein angiography eyes that received Fovista®1.5 mg combination therapy had greater inhibition of choroidal neovascularization (CNV) and fibrosis compared to those receiving ranibizumab monotherapy. At 24 weeks, RPE atrophy was evident in 20.8% (30/144) eyes in the ranibizumab monotherapy group, 16.8% (24/143) in the Fovista® 0.3 mg combination therapy group, and 15.9% (23/145) in the Fovista® 1.5 mg combination therapy group.
At 24 weeks, compared to ranibizumab monotherapy, Fovista® combination therapy resulted in reduction of sub-retinal fibrosis and CNV growth, while also showing a lower occurrence of RPE atrophy. Fovista® combination therapy may address the underlying mechanisms of chronic insidious vision loss in NAMD.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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