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Christine Read Gonzales, Gabriela Burian; 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. 2017;58(8):3766.
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Current anti-VEGF therapies for wetAMD reduce leakage and exudation but do not appear to reverse CNV progression. This study examined the hypothesis that ICON-1, an anti-Tissue Factor (TF) immunoconjugate protein, binds to CNV overexpressing TF and via a new mechanism of action acts to reduce CNV activity alone or in combination with ranibizumab (RBZ).
EMERGE was a randomized, double masked, active control study in the United States. A total of 88 patients with treatment naïve CNV secondary to AMD were enrolled. Patients were randomized 1:1:1 and received intravitreal injections of ICON-1 0.3mg as monotherapy (n=30), ICON-1 0.3mg in combination with ranibizumab 0.5mg (n=30) or ranibizumab 0.5mg monotherapy (n=28). Patients received 3 initial monthly injections, then remained masked in their respective randomized group for additional 3 possible injections based on protocol retreatment criteria. Safety, BCVA letter score and CNV lesion activity were assessed monthly with optical coherence tomography (sdOCT) and quarterly with fluorescein angiography (FA).
No serious ocular adverse events were reported. The most frequently reported study eye ocular adverse events (AEs) in all groups were conjunctival hemorrhage (13.3-26.7%), vitreous floaters (10.7-13.3%), eye pain (3.3-23.3%) and retinal hemorrhage due to AMD (0-26.7%). After the 3 fixed injections, mean BCVA increased from baseline to Month 3 (primary endpoint) by 0.3 letters with ICON-1 monotherapy, 6.8 letters with ICON-1 in combination with RBZ, and 7.6 letters with RBZ monotherapy and was associated with CRT reduction in all treatment groups. From Month 3 to 6, fewer patients in the ICON-1 combination group (60%) received at least one additional injection compared to ICON-1 (82.8%) and RBZ (85.2%) monotherapy. Mean BCVA and mean CRT between months 3 and 6 were maintained in all treatment groups.
Repeated intravitreal ICON-1 0.3mg injections alone or in combination with RBZ were well tolerated. BCVA gain was comparable in the ICON-1 combination and RBZ groups, although it was maintained with fewer treatments from Month 3 to 6 with ICON-1 combination. Together with signs of reduction in CNV activity (FA and sdOCT), these results provide biological signals of ICON-1 activity on the reduction of CNV progression.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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