Trial of Aganirsen in iCRVO Patients at Risk of Developing NVG

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gene Signal SAS
• Collaborators: Johannes Gutenberg University Mainz; Moorfields Eye Hospital NHS Foundation Trust; University Hospital of Cologne

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