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Trial record 1 of 1 for:    NCT02947867
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Trial of Aganirsen in iCRVO Patients at Risk of Developing NVG (STRONG)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified October 2016 by Gene Signal SAS
Sponsor:
Collaborators:
Johannes Gutenberg University Mainz
University Hospital of Cologne
Moorfields Eye Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Gene Signal SAS
ClinicalTrials.gov Identifier:
NCT02947867
First received: October 15, 2016
Last updated: October 28, 2016
Last verified: October 2016
  Purpose
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

Condition Intervention Phase
Ischaemic Central Retinal Vein Occlusion Neovascular Glaucoma Drug: aganirsen Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Develop Neovascular Glaucoma

Resource links provided by NLM:


Further study details as provided by Gene Signal SAS:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 333
Study Start Date: January 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aganirsen "low-dose":
43µg daily, one drop of 0.86 mg/g emulsion (morning) + one drop of placebo (evening) daily
Drug: aganirsen
aganirsen antisense oligonucleotide against Insulin Receptor Substrate (IRS-1)
Other Name: GS-101
Experimental: aganirsen "high-dose"
86µg daily, one drop of 0.86 mg/g emulsion twice daily (morning and evening)
Drug: aganirsen
aganirsen antisense oligonucleotide against Insulin Receptor Substrate (IRS-1)
Other Name: GS-101
Placebo Comparator: aganirsen placebo (vehicle)
one drop of placebo emulsion (morning) + one drop of placebo emulsion (evening) daily
Drug: aganirsen
aganirsen antisense oligonucleotide against Insulin Receptor Substrate (IRS-1)
Other Name: GS-101

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects meeting all of the following criteria will be considered for enrolment to the trial:

  • Male or female ≥ 18 years
  • IOP in the study eye ≤ 21mmHg
  • Primary ischaemic CRVO or conversion to ischaemic CRVO in the study eye for no longer than 4 weeks
  • Best-corrected visual acuity (BCVA) ETDRS letter score < 35 (< 20/200 Snellen equivalent) in the study eye
  • ≥ 10-disc area of retinal capillary obliteration on fluorescein fundus angiography in the study eye (central fundus: macular area as defined by the optic disc and the arcades, an approximate 6000 micron circle around the fovea) and/or large, confluent retinal haemorrhages in the study eye

Must be accompanied by 4 or more out of 6 following criteria:

  • A relative afferent pupillary defect (with a normal fellow eye)
  • ≥ 10 cotton-wool-spots in the study eye
  • Venous tortuosity in the study eye
  • Peripheral visual field defects corresponding to ischaemia (Goldmann perimeter or other semi-automatic kinetic methods) in the study eye
  • Engorged vessels on iris and/or in the chamber angle in the study eye
  • Detectable anterior chamber flare in the study eye

Exclusion Criteria:

Subjects presenting 1 or more of the following criteria will not be enrolled in the trial:

  • Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
  • Primary or secondary glaucoma in the study eye
  • Prior or concomitant ocular treatment with anti-VEGF in the study eye (ranibizumab/bevacizumab is not allowed within the last 45 days, aflibercept within the last 90 days) before screening visit
  • Use of anti-VEGF treatment in the fellow eye during the trial
  • Previous use of intraocular corticosteroids at any time or use of periocular corticosteroids in the study eye within 90 days prior to screening visit
  • History of idiopathic or autoimmune uveitis in either eye
  • Presence of NVD, NVE or anterior segment neovascularisation (NVA or NVI) in the study eye
  • Previous PRP in the study eye
  • Intraocular surgery (other than intravitreal anti-VEGF treatment) or laser treatment in the study eye within the past 90 days before screening visit
  • Patients with a history of breast cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02947867

Contacts
Contact: Katrin Lorenz, MD +49613117 ext 4069 katrin.lorenz@unimedizin-mainz.de
Contact: Yvonne Scheller, PhD +49613117 ext 3367 yvonne.scheller@unimedizin-mainz.de

Sponsors and Collaborators
Gene Signal SAS
Johannes Gutenberg University Mainz
University Hospital of Cologne
Moorfields Eye Hospital NHS Foundation Trust
  More Information

Responsible Party: Gene Signal SAS
ClinicalTrials.gov Identifier: NCT02947867     History of Changes
Other Study ID Numbers: GS-101-P1-NVR
2014-000239-18 ( EudraCT Number )
Study First Received: October 15, 2016
Last Updated: October 28, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Ischemia
Glaucoma
Retinal Vein Occlusion
Glaucoma, Neovascular
Pathologic Processes
Ocular Hypertension
Eye Diseases
Retinal Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2017