Trial of Aganirsen in iCRVO Patients at Risk of Developing NVG

NCT02947867 | Unknown Phase 2 DMC

• 2 other identifiers: GS-101-P1-NVR2014-000239-18
• Study Type: interventional
• Target: 333
• Locations: 0 countries
• Sites: N/A

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

Conditions

Ischaemic Central Retinal Vein Occlusion; Neovascular Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (11)

• Secondary NVG

  24 weeks

• Anterior segment neovascularisation

  24 weeks

• NVG Classification

  24 weeks

• Visual Acuity

  24 weeks

• Number of additional needed laser treatments and re-treatments in the study eye at up to week 24

  24 weeks

Study Arms (3)

aganirsen "low-dose":

EXPERIMENTAL

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

Drug: aganirsen

aganirsen "high-dose"

EXPERIMENTAL

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

Drug: aganirsen

aganirsen placebo (vehicle)

PLACEBO COMPARATOR

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

Drug: aganirsen

Interventions

aganirsen DRUG

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

Also known as: GS-101

aganirsen "high-dose"; aganirsen "low-dose":; aganirsen placebo (vehicle)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gene Signal SAS: lead
• Johannes Gutenberg University Mainz: collaborator
• University Hospital of Cologne: collaborator
• Moorfields Eye Hospital NHS Foundation Trust: collaborator

Related Publications (1)

• 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.

  PMID: 28302155 DERIVED

MeSH Terms

Conditions

Glaucoma, Neovascular

Interventions

GS 101

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Central Study Contacts

Katrin Lorenz, MD

CONTACT

+49613117; katrin.lorenz@unimedizin-mainz.de

Yvonne Scheller, PhD

CONTACT

+49613117; yvonne.scheller@unimedizin-mainz.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2016
• First Posted: October 28, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 31, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share