June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
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)
Author Affiliations & Notes
  • Christine Read Gonzales
    Retina and Vitreous Center, Ashland, Oregon, United States
  • Gabriela Burian
    GB Biomed Advisors, Oberwil, Basel-Landschaft, Switzerland
  • Footnotes
    Commercial Relationships   Christine Gonzales, Iconic Therapeutics (R), Iconic Therapeutics, Inc. (F); Gabriela Burian, Iconic Therapeutics, Inc. (C), Iconic Therapeutics, Inc. (P), Iconic Therapeutics, Inc. (R)
  • Footnotes
    Support  Iconic IT-002
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 3766. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : 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).

Methods : 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).

Results : 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.

Conclusions : 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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