NCT02947867

Trial of Aganirsen in iCRVO Patients at Risk of Developing NVG

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 333 (estimated)
• Sponsor: Gene Signal SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	aganirsen	aganirsen antisense oligonucleotide against Insulin Receptor Substrate (IRS-1)

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-06-01
• Completion: 2019-12-01
• First posted: 2016-10-28
• Last updated: 2016-10-31