Trial of Aganirsen in iCRVO Patients at Risk of Developing NVG

NCT ID: NCT02947867

Last Updated: 2016-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-12-31

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 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.

Conditions

Ischaemic Central Retinal Vein Occlusion; Neovascular Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

aganirsen "low-dose":

43µg daily, one drop of 0.86 mg/g emulsion (morning) + one drop of placebo (evening) daily

Group Type: EXPERIMENTAL

aganirsen

Intervention Type: DRUG

aganirsen antisense oligonucleotide against Insulin Receptor Substrate (IRS-1)

aganirsen "high-dose"

86µg daily, one drop of 0.86 mg/g emulsion twice daily (morning and evening)

Group Type: EXPERIMENTAL

aganirsen

Intervention Type: DRUG

aganirsen antisense oligonucleotide against Insulin Receptor Substrate (IRS-1)

aganirsen placebo (vehicle)

one drop of placebo emulsion (morning) + one drop of placebo emulsion (evening) daily

Group Type: PLACEBO_COMPARATOR

aganirsen

Intervention Type: DRUG

aganirsen antisense oligonucleotide against Insulin Receptor Substrate (IRS-1)

Interventions

aganirsen

aganirsen antisense oligonucleotide against Insulin Receptor Substrate (IRS-1)

Intervention Type: DRUG

Other Intervention Names

GS-101

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: collaborator

University Hospital of Cologne

OTHER

Sponsor Role: collaborator

Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Gene Signal SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Katrin Lorenz, MD

Role: CONTACT

Phone: +49613117

Email: katrin.lorenz@unimedizin-mainz.de

Yvonne Scheller, PhD

Role: CONTACT

Phone: +49613117

Email: yvonne.scheller@unimedizin-mainz.de

References

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.

Reference Type: DERIVED

PMID: 28302155 (View on PubMed)

Other Identifiers

2014-000239-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-101-P1-NVR

Identifier Type: -

Identifier Source: org_study_id