Clinical Trial: Trial of Aganirsen in iCRVO Patients at Risk of Developing NVG

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Prospective, Randomised, Placebo-controlled, Double-masked, Three-armed Multi-centre Trial of Aganirsen Versus Vehicle in Patients After Ischaemic Central Retinal Vein Occlusion With a High Risk to De

Brief Summary: A prospective, randomised, placebo-controlled, double-masked, three-armed multi-centre phase II/III trial for the Study of a Topical Treatment of Ischaemic Central Retinal Vein Occlusion to Prevent Neovascular Glaucoma - the STRONG Study

Detailed Summary: The STRONG Study is a phase II/III prospective, randomised, placebo-controlled, double-masked, three-armed multi-centre study of aganirsen antisense oligonucleotide, a topical treatment for iCRVO intended to prevent Neovascular Glaucoma (NVG). The study will evaluate the efficacy of two different doses of aganirsen formulated in an eye emulsion in avoiding new vessel formation by blocking the Insulin Receptor Substrate (IRS)-1. Eligible patients will be treated with aganirsen or placebo for a period of 24 weeks. They will also be invited to participate in sub-studies working on the analysis of gonioscopic images, detection of biomarkers for neovascular glaucoma and risk factors for ischaemic central retinal vein occlusion.
Sponsor: Gene Signal SAS

Current Primary Outcome:

  • NVG component [ Time Frame: Week 24 ]
    Co-primary I: NVG component scored dichotomously (NVG=yes/NVG=no) where "yes" is development of NVI, NVA, NVD, and/or NVE, or rescue treatment; "no" otherwise
  • IOP component [ Time Frame: Week 24 ]
    Co-primary II: IOP component scored dichotomously (failure/success); "failure" is rise in IOP from baseline to week 24 of ≥ 20% to > 21 or rescue treatment; "success" otherwise


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Secondary NVG [ Time Frame: 24 weeks ]
    The time to development of secondary NVG in the study eye up to week 24 (in case aganirsen does not totally inhibit but slows down the development of NVG).
  • Anterior segment neovascularisation [ Time Frame: 24 weeks ]
    The time to development of anterior segment neovascularisation (NVI or NVA), NVD or NVE in the study eye, requiring PRP or cryotherapy up to week 24.
  • NVG Classification [ Time Frame: 24 weeks ]
    NVG Classification at 24 weeks on a scale from 1 (non-NVG) to 6 (most advanced NVG) based on central reading of neovascularisation
  • Visual Acuity [ Time Frame: 24 weeks ]
    The change from baseline in BCVA (EDTRS letter score) in the study eye to week 24.
  • Number of additional needed laser treatments and re-treatments in the study eye at up to week 24 [ Time Frame: 24 weeks ]
    Number of additional needed laser treatments and re-treatments in the study eye at up to week 24
  • Required intensity of laser spots of additional laser treatments and re-treatments in the study eye at up to week 24 [ Time Frame: 24 weeks ]
    Required intensity of laser spots of additional laser treatments and re-treatments in the study eye at up to week 24
  • Retinal non-perfusion area [ Time Frame: 24 weeks ]
    The change from baseline in size of retinal non-perfusion areas in the study eye to week 24
  • Retinal Thickness [ Time Frame: 24 weeks ]
    Absolute change from baseline in retinal thickness in the study eye, assessed by spectral domain optical coherence tomography (SD-OCT) at week 24
  • Quality of Life [ Time Frame: 24 weeks ]
    The change from baseline in the NEI-VFQ-25 health questionnaire total score to week 24
  • Quality of Life on EQ-5D [ Time Frame: 24 weeks ]
    The change from baseline in the EQ-5D health questionnaire score to week 24
  • Safety: Incidence of treatment-emergent Adverse Events [ Time Frame: 24 weeks ]
    Incidence, causality and intensity of adverse events between the treatment arms


Original Secondary Outcome: Same as current

Information By: Gene Signal SAS

Dates:
Date Received: October 15, 2016
Date Started: January 2017
Date Completion: December 2019
Last Updated: October 28, 2016
Last Verified: October 2016