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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000239-18 | EudraCT Number |
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| Name | Class |
|---|---|
| Johannes Gutenberg University Mainz | OTHER |
| University Hospital of Cologne | OTHER |
| Moorfields Eye Hospital NHS Foundation Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aganirsen "low-dose": | Experimental | 43µg daily, one drop of 0.86 mg/g emulsion (morning) + one drop of placebo (evening) daily |
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| aganirsen "high-dose" | Experimental | 86µg daily, one drop of 0.86 mg/g emulsion twice daily (morning and evening) |
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| aganirsen placebo (vehicle) | Placebo Comparator | one drop of placebo emulsion (morning) + one drop of placebo emulsion (evening) daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aganirsen | Drug | aganirsen antisense oligonucleotide against Insulin Receptor Substrate (IRS-1) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 weeks |
| Anterior segment neovascularisation |
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Inclusion Criteria:
Subjects meeting all of the following criteria will be considered for enrolment to the trial:
Must be accompanied by 4 or more out of 6 following criteria:
Exclusion Criteria:
Subjects presenting 1 or more of the following criteria will not be enrolled in the trial:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katrin Lorenz, MD | Contact | +49613117 | 4069 | katrin.lorenz@unimedizin-mainz.de |
| Yvonne Scheller, PhD | Contact | +49613117 | 3367 | yvonne.scheller@unimedizin-mainz.de |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28302155 | Derived | Lorenz K, Scheller Y, Bell K, Grus F, Ponto KA, Bock F, Cursiefen C, Flach J, Gehring M, Peto T, Silva R, Tal Y, Pfeiffer N. A prospective, randomised, placebo-controlled, double-masked, three-armed, multicentre phase II/III trial for the Study of a Topical Treatment of Ischaemic Central Retinal Vein Occlusion to Prevent Neovascular Glaucoma - the STRONG study: study protocol for a randomised controlled trial. Trials. 2017 Mar 16;18(1):128. doi: 10.1186/s13063-017-1861-3. |
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| ID | Term |
|---|---|
| D015355 | Glaucoma, Neovascular |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C540750 | GS 101 |
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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.
| 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 | 24 weeks |
| Visual Acuity | The change from baseline in BCVA (EDTRS letter score) in the study eye to week 24. | 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 | 24 weeks |
| 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 | 24 weeks |
| Retinal non-perfusion area | The change from baseline in size of retinal non-perfusion areas in the study eye to week 24 | 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 | 24 weeks |
| Quality of Life | The change from baseline in the NEI-VFQ-25 health questionnaire total score to week 24 | 24 weeks |
| Quality of Life on EQ-5D | The change from baseline in the EQ-5D health questionnaire score to week 24 | 24 weeks |
| Safety: Incidence of treatment-emergent Adverse Events | Incidence, causality and intensity of adverse events between the treatment arms | 24 weeks |