STRONG

European Consortium for the Study of a Topical Treatment of Neovascular Glaucoma

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 Obiettivo del progetto (Objective)

'Neovascular glaucoma (NVG) is a very aggressive and rare type of glaucoma: yet, it contributes disproportionately to blindness from all eye diseases. NVG is also the second most common cause for the removal of the eye-ball across all eye diseases, usually because of intractable pain. The major cause of NVG is Ischaemic Central Retinal Vein Occlusion (CRVO) leading to neovascularisation, obstruction of aqueous humour outflow and increased intraocular pressure. Today’s therapeutic approaches are insufficient: they include destruction of the retina by coagulation, or off-label anti-VEGF injection into the eye. It is proposed to develop a better treatment by assessing the topical administration of Aganirsen: it is an antisense oligonucleotide able to interrupt the production of Vascular Endothelial Growth Factor, which plays a major role in the pathogenesis of NVG. Aganirsen is developed by GENE SIGNAL, a SME with expertise in topical ophthalmic treatments for orphan diseases, and manufactured by AMATSI. Under the coordination of the Mainz University Medical Center, a Phase II/III randomised, double-masked, 3-group, placebo-controlled trial (STRONG) is therefore presented to assess Aganirsen’s efficacy in reducing the rate of anterior and posterior segment neovascularisation and NVG development after CRVO. Involving 333 subjects within more than 30 clinical sites, the study is operationalized via a disease specific network (EVICR.net) and a contract research organization managed by GENE SIGNAL. The study aims at assessing a new therapeutic approach for NVG for which conditional authorization will be sought at the end of the project. STRONG also delivers new insights into the natural course of the disease and its risk factors, analysing one of the largest patient cohorts ever. It also allows for a novel classification of NVG, yields novel image analysis tools, and proposes biomarkers able to differentiate between high- and low-risk patients and drug responders.'

Introduzione (Teaser)

European scientists are in the process of testing a novel molecular drug to treat neovascular glaucoma following ischaemic central retinal vein occlusion.

Descrizione progetto (Article)

Neovascular glaucoma (NVG) is a very aggressive form of glaucoma that accounts for nearly 4 % of all glaucoma cases. It is mainly associated with ischaemic central retinal vein occlusion (iCRVO) and often leads to blindness as well as removal of the eyeball due to severe pain. Current treatments include lowering the intraocular pressure, laser therapy or administration of anti-angiogenic compounds. However, the limited efficacy of these approaches necessitates the need for new alternative strategies in an early phase of NVG.

With this in mind, partners on the EU-funded 'European consortium for the study of a topical treatment of neovascular glaucoma' (http://strong-nvg.com/ (STRONG)) initiative propose a different approach to halt the release of angiogenic factors. Their strategy is based on the use of antisense oligonucleotides against insulin receptor substrate 1. Results from previous studies indicate the potential of this oligonucleotide to inhibit vascular endothelial growth factor secretion, which seems to play a key role in the pathogenesis of NVG.

STRONG will evaluate the efficacy of the antisense oligonucleotide to inhibit neovascularisation in a randomised phase II/III trial. It will also study a large cohort of patients to provide information on the natural course of NVG, paying particular attention to risk factors and biomarkers for the development and progression of NVG. A further objective is to improve the early diagnosis of NVG by image and biomorphometric analyses.

The consortium has received approval for a clinical trial that will test the use of antisense oligonucleotides as a preventative intervention for NVG. So far a total of 28 centres across 7 countries have expressed interest in participating in the trial. Most documents and standard operating procedures have been finalised alongside an electronic data capture system.

Outcomes of the STRONG clinical trial should validate the targeted prevention of angiogenesis as an innovative treatment of NVG following iCRVO. The topical, non-invasive nature of the proposed intervention offers a significant advantage to existing procedures.