Ischaemic Central Retinal Vein OcclusionPhase 2/3STRONGNCT02947867
Trial of Aganirsen in iCRVO Patients at Risk of Developing NVG
A Phase 2/3 study testing aganirsen in people with Ischaemic Central Retinal Vein Occlusion and Neovascular Glaucoma, run by Gene Signal SAS.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischaemic Central Retinal Vein Occlusion, Neovascular Glaucoma
- What is being tested?
- aganirsen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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
Read the 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.
- Being tested
- aganirsen
- Medical subject headings
- Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aganirsenDrug
Also called GS-101
aganirsen antisense oligonucleotide against Insulin Receptor Substrate (IRS-1)
| Study group | Role | What they receive |
|---|---|---|
| aganirsen "low-dose": | Experimental | 43µg daily, one drop of 0.86 mg/g emulsion (morning) + one drop of placebo (evening) daily Receives: Drug: aganirsen |
| aganirsen "high-dose" | Experimental | 86µg daily, one drop of 0.86 mg/g emulsion twice daily (morning and evening) Receives: Drug: aganirsen |
| aganirsen placebo (vehicle) | Placebo comparator | one drop of placebo emulsion (morning) + one drop of placebo emulsion (evening) daily Receives: Drug: aganirsen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 24
Secondary outcomes (11)
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).
Measured: 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.
Measured: 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
Measured: 24 weeks
Visual Acuity
The change from baseline in BCVA (EDTRS letter score) in the study eye to week 24.
Measured: 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
Measured: 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
Measured: 24 weeks
Retinal non-perfusion area
The change from baseline in size of retinal non-perfusion areas in the study eye to week 24
Measured: 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
Measured: 24 weeks
Quality of Life
The change from baseline in the NEI-VFQ-25 health questionnaire total score to week 24
Measured: 24 weeks
Quality of Life on EQ-5D
The change from baseline in the EQ-5D health questionnaire score to week 24
Measured: 24 weeks
Safety: Incidence of treatment-emergent Adverse Events
Incidence, causality and intensity of adverse events between the treatment arms
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischaemic Central Retinal Vein OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gene Signal SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johannes Gutenberg University Mainz, University Hospital of Cologne, Moorfields Eye Hospital NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947867
- Sponsor's protocol ID
- GS-101-P1-NVR
- Other IDs
- 2014-000239-18, 2014
- Acronym
- STRONG
- Status last verified
- Oct 2016
- First submitted
- 15 Oct 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28302155
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02947867
- Acronym / sponsor ID
- STRONG / GS-101-P1-NVR
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 333 participants (estimated)
- Lead sponsor
- Gene Signal SASIndustry (pharma, biotech, devices)
- Collaborators
- Johannes Gutenberg University Mainz, University Hospital of Cologne, Moorfields Eye Hospital NHS Foundation Trust
- Study start
- Jan 2017
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aganirsen "low-dose": | Experimental | Drug: aganirsen43µg daily, one drop of 0.86 mg/g emulsion (morning) + one drop of placebo (evening) daily |
| aganirsen "high-dose" | Experimental | Drug: aganirsen86µg daily, one drop of 0.86 mg/g emulsion twice daily (morning and evening) |
| aganirsen placebo (vehicle) | Placebo comparator | Drug: aganirsenone drop of placebo emulsion (morning) + one drop of placebo emulsion (evening) daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aganirsenAlso: GS-101aganirsen antisense oligonucleotide against Insulin Receptor Substrate (IRS-1) | Drug | aganirsen "high-dose", aganirsen "low-dose":, aganirsen placebo (vehicle) |
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
11 secondary outcomes
Secondary NVG
Time frame: 24 weeks
Anterior segment neovascularisation
Time frame: 24 weeks
NVG Classification
Time frame: 24 weeks
Visual Acuity
Time frame: 24 weeks
Number of additional needed 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
Time frame: 24 weeks
Retinal non-perfusion area
Time frame: 24 weeks
Retinal Thickness
Time frame: 24 weeks
Quality of Life
Time frame: 24 weeks
Quality of Life on EQ-5D
Time frame: 24 weeks
Safety: Incidence of treatment-emergent Adverse Events
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Derived from this study: PubMed 28302155Lorenz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing aganirsen in people with Ischaemic Central Retinal Vein Occlusion and Neovascular Glaucoma, run by Gene Signal SAS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrin Lorenz, MD (+49613117 ext. 4069, katrin.lorenz@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NVG component (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02947867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.