March 2012
Volume 53, Issue 14
Free
ARVO Annual Meeting Abstract  |   March 2012
Multicenter Phase 1 Clinical Trial Targeting Tissue Factor for the Treatment of Neovascular AMD
Author Affiliations & Notes
  • John A. Wells, III
    Ophthalmology, Palmetto Retina Center, West Columbia, South Carolina
  • Brian B. Berger
    Retina Research Center, Austin, Texas
  • Christine Gonzales
    Ophthalmology, Retina and Vitreous Center of Southern Oregon, Ashland, Oregon
  • Victor H. Gonzales
    Valley Retina Institute, McAllen, Texas
  • David L. Johnson
    Ophthalmology, Palmetto Retina Center, West Columbia, South Carolina
  • Brian D. Sippy
    Ophthalmology, Rocky Mountain Eye Ctr, PC, Missoula, Montana
  • Manju Soni
    Numa LLC, Mystic, Connecticut
  • Footnotes
    Commercial Relationships  John A. Wells, III, Eyetech (C, R), Genentech (F), LPath Inc (F), Novartis (F), Ophthotech (F), Pfizer Inc (F), Steba (F); Brian B. Berger, Genentech (F), Iconic Therapeutics (F), Lpath Inc (F), NeoVista Pharmaceuticals (F), Pfizer Inc (F); Christine Gonzales, Eyetech (C), Iconic Therapeutics (F), Ophthotech (F); Victor H. Gonzales, Eyetech (C, R), Genentech (F, C), Iconic Therapeutics (F), Ophthotech (F), Pfizer (C, R), Pfizer Inc (F), Regeneron (F), Steba (F); David L. Johnson, Genentech (F), Iconic Therapeutics (F), Lpath Inc (F), Ophthotech (F), Regeneron (F); Brian D. Sippy, Iconic Therapeutics (F), Regeneron (F); Manju Soni, Iconic Therapeutics (C)
  • Footnotes
    Support  Iconic Therapeutics, Inc
Investigative Ophthalmology & Visual Science March 2012, Vol.53, 450. doi:
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      John A. Wells, III, Brian B. Berger, Christine Gonzales, Victor H. Gonzales, David L. Johnson, Brian D. Sippy, Manju Soni; Multicenter Phase 1 Clinical Trial Targeting Tissue Factor for the Treatment of Neovascular AMD. Invest. Ophthalmol. Vis. Sci. 2012;53(14):450.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : To evaluate the safety and tolerability of binding tissue factor with hI-con1™, alone or in combination with anti-VEGF therapy, in eyes with active neovascular AMD.

Methods: : This prospective, multi-center, dose-escalating clinical study evaluated the safety and tolerability of a single, intravitreal injection of 60µg, 150µg and 300µg of hI-con1 in 18 patients (6 per cohort). Ocular inclusion criteria included active CNV with at least a 30% classic component on angiography and VA 20/63 - CF. Eyes with end-stage CNV, eyes on chronic anti-VEGF therapy and treatment naïve eyes were enrolled. Anti-VEGF therapy was allowed 2 weeks after the hI-con1 injection at the investigator’s discretion.

Results: : No ocular or systemic dose limiting toxicities were identified. No retinal or choroidal vascular, inflammatory or hemorrhagic toxicities were identified. Patients reported no drug related adverse events. hI-con1, administered alone or adjunctively with an anti-VEGF agent, showed multiple, dose-related biologic signals across the broad spectrum of treated eyes. An interim analysis of 6 eyes in the high-dose 300μg cohort at Day 57 showed:• 67% showed reduced OCT thickness, some CNV regression on angiography and ≥ 3 lines improved BCVA.• 100% of the 3 treatment naïve eyes showed reduced OCT thickness, some CNV regression on angiography and ≥ 3 lines improved BCVA.An interim analysis of all dose cohorts additionally showed:• The mean BCVA of 7 eyes on chronic anti-VEGF therapy (mean number of previous anti-VEGF injections = 6; all with persistent sub-retinal fluid; VA = 20/80 or worse) at Day 29 was +9 letters compared to baseline; at Day 57, +7 letters compared to baseline.• The mean BCVA of 9 patients receiving one hI-con1 plus one anti-VEGF injection was +11 letters 29 days after the anti-VEGF injection.• 67% of all 18 eyes went 57 days without resuming anti-VEGF therapy; 50% of all eyes went 85 days or longer without additional anti-VEGF therapy.

Conclusions: : A single injection of hI-con1, alone or in combination with anti-VEGF agents, showed no ocular or systemic safety signals. Evidence of biologic activity with reduced OCT thickness, evidence of CNV regression, and gains in BCVA was observed in many of the treated eyes. Further studies are planned.

Clinical Trial: : http://www.clinicaltrials.gov NCT01485588

Keywords: age-related macular degeneration • choroid: neovascularization 
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