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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
333
aganirsen antisense oligonucleotide against Insulin Receptor Substrate (IRS-1)
NVG component
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
Time frame: Week 24
IOP component
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
Time frame: Week 24
Secondary NVG
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).
Time frame: 24 weeks
Anterior segment neovascularisation
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.
Time frame: 24 weeks
NVG Classification
NVG Classification at 24 weeks on a scale from 1 (non-NVG) to 6 (most advanced NVG) based on central reading of neovascularisation
Time frame: 24 weeks
Visual Acuity
The change from baseline in BCVA (EDTRS letter score) in the study eye 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
Number of additional needed laser treatments and re-treatments in the study eye at up to week 24
Time frame: 24 weeks
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Required intensity of laser spots of additional 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
Retinal non-perfusion area
The change from baseline in size of retinal non-perfusion areas in the study eye to week 24
Time frame: 24 weeks
Retinal Thickness
Absolute change from baseline in retinal thickness in the study eye, assessed by spectral domain optical coherence tomography (SD-OCT) at week 24
Time frame: 24 weeks
Quality of Life
The change from baseline in the NEI-VFQ-25 health questionnaire total score to week 24
Time frame: 24 weeks
Quality of Life on EQ-5D
The change from baseline in the EQ-5D health questionnaire score to week 24
Time frame: 24 weeks
Safety: Incidence of treatment-emergent Adverse Events
Incidence, causality and intensity of adverse events between the treatment arms
Time frame: 24 weeks