September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
A phase I First-In Human single ascending dose study of ISTH0036, a potent and selective antisense oligonucleotide targeting transforming growth factor beta 2 (TGF-β2) for the treatment of primary open-angle glaucoma
Author Affiliations & Notes
  • Bogomil Voykov
    Centre for Ophthalmology, University Hospital Tuebingen, Tuebingen, Germany
  • Katrin Lorenz
    Ophthalmology, University Medical Center Mainz, Mainz, Germany
  • Claudia Schuart
    Ophthalmology, Otto-von-Guericke-University, Magdeburg, Germany
  • Paul Richter
    Centre for Ophthalmology, University Hospital Tuebingen, Tuebingen, Germany
  • Barbara Wilhelm
    STZ Eyetrial at the Centre for Ophthalmology, University Hospital Tuebingen, Tuebingen, Germany
  • Lars Choritz
    Ophthalmology, Otto-von-Guericke-University, Magdeburg, Germany
  • Verena Prokosch-Willing
    Ophthalmology, University Medical Center Mainz, Mainz, Germany
  • Petra Fettes
    Isarna Therapeutics GmbH, Munich, Germany
  • Eugen Leo
    Isarna Therapeutics GmbH, Munich, Germany
  • Norbert Pfeiffer
    Ophthalmology, University Medical Center Mainz, Mainz, Germany
  • Footnotes
    Commercial Relationships   Bogomil Voykov, None; Katrin Lorenz, None; Claudia Schuart, None; Paul Richter, None; Barbara Wilhelm, None; Lars Choritz, None; Verena Prokosch-Willing, None; Petra Fettes, Isarna Therapeutics GmbH (E); Eugen Leo, Isarna Therapeutics GmbH (E); Norbert Pfeiffer, Isarna Therapeutics GmbH (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3029. doi:
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      Bogomil Voykov, Katrin Lorenz, Claudia Schuart, Paul Richter, Barbara Wilhelm, Lars Choritz, Verena Prokosch-Willing, Petra Fettes, Eugen Leo, Norbert Pfeiffer; A phase I First-In Human single ascending dose study of ISTH0036, a potent and selective antisense oligonucleotide targeting transforming growth factor beta 2 (TGF-β2) for the treatment of primary open-angle glaucoma. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3029.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose : To study the safety and tolerability and preliminary clinical efficacy of intravitreal ISTH0036 in patients with primary open angle glaucoma (POAG) undergoing trabeculectomy with mitomycin C.

Methods : This prospective Phase I trial is performed at three sites. Glaucoma patients scheduled for filtration surgery receive intravitreal injections of ISTH0036 at the end of trabeculectomy in escalating total doses of 6.75 µg, 22.5 µg, 67.5 µg or 225 µg, respectively, resulting in calculated intraocular ISTH0036 concentrations in the humor of 0.3 µM, 1 µM, 3 µM or 10 µM after injection. Outcomes assessed include: type and frequency of adverse events, intraocular pressure (IOP), number of interventions post trabeculectomy, bleb survival, visual acuity and visual field, slit lamp biomicroscopy and optic disc status.

Results : In this ongoing study so far six patients have been treated (dose level 1 and – ongoing - dose level 2). For dose level 1 good safety and tolerability was confirmed. No treatment associated adverse events or dose limiting toxicities were observed. The mean pre-operative IOP of patients at dose level 1 was 34.7 mmHg and post-operative 9.8 mmHg at the 6 week follow up and 9.7 mmHg at the 12 week follow up (SD: 13.35, 0.82, and 2.66, respectively). Updated results of this ongoing trial will be presented at the meeting.

Conclusions : Preliminary results of this First-in-Human trial suggest that intravitreal injection at the end of trabeculectomy of ISTH0036, a potent and selective antisense oligonucleotide targeting transforming growth factor beta 2 (TGF-β2) ISTH0036 is safe and well tolerable.

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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