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Nancy J Christmas; A Phase 2 Study (EMERGE) Evaluating Repeated Intravitreal Administration of ICON-1 in Patients With Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD). Invest. Ophthalmol. Vis. Sci. 2016;57(12):4434.
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© ARVO (1962-2015); The Authors (2016-present)
Current anti-VEGF therapies for wet AMD reduce neovascular leakage and exudation but do not appear to reverse the abnormal CNV progression in wet AMD. This Phase 2 study examines the hypothesis that ICON-1, an anti-Tissue Factor (TF) immunoconjugate protein, binds to pathologic vessels overexpressing TF and acts via a new mechanism of action that can eliminate abnormal CNV as well as inhibit the exudation either alone or in combination with ranibizumab as compared to ranibizumab alone.
EMERGE is a randomized, double masked, active control study in the United States. A total of 90 patients with treatment naïve (in the study eye) CNV secondary to AMD are being enrolled. Patient inclusion criteria include: ≥ 50 years of age, active primary CNV due to AMD, Best Corrected Visual Acuity (BCVA) of 70 to 24 letters (worse than 20/40 and up to 20/320 Snellen equivalent) in the study eye. Lesion characteristics include: a total lesion size <6 disc areas (DA), CNV >50% of lesion size, presence of retinal fluid on Optical Coherence Tomography (sdOCT). Patients are randomized in a 1:1:1 ratio to receive intravitreal injections of ICON-1 (0.3 mg) as monotherapy (n=30) or in combination with ranibizumab 0.5 mg (n=30) or ranibizumab 0.5 mg monotherapy (n=30). Patients will receive 3 initial monthly injections followed by maximum 3 additional monthly injections based on protocol re-treatment criteria, for a total of 6 months of treatment. The primary outcomes are mean change from baseline in BCVA letter score and in Central Retinal Thickness (CRT) at 3 months.
The rationale for the study design, the mechanism of action of ICON-1 and targeting TF, and detailed demographic characteristics of enrolled patients will be presented.
The EMERGE study will provide important insight into whether ICON-1 with its new anti-TF mechanism of action, administered as monotherapy or in combination with ranibizumab, leads to a modification of the CNV lesion along with reduction of leakage, exudation and BCVA improvements, when compared to ranibizumab alone.
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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