Universität zu Köln

Lorenz, Katrin, Scheller, Yvonne, Bell, Katharina, Grus, Franz, Ponto, Katharina A., Bock, Felix, Cursiefen, Claus, Flach, Jens, Gehring, Marta, Peto, Tunde ORCID: 0000-0001-6265-0381, Silva, Rufino, Tal, Yossi and Pfeiffer, Norbert (2017). A prospective, randomised, placebocontrolled, 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, 18. LONDON: BMC. ISSN 1745-6215

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Abstract

Background: Neovascular glaucoma (NVG) is rare, comprising only 3.9% of all glaucoma cases. The most common cause of NVG is ischaemic central retinal vein occlusion (iCRVO). NVG frequently results in blindness and painful end- stage glaucomatous damage leading to the need for enucleation. Currently, there is no preventive therapy for NVG following iCRVO. Rescue treatments have severe drawbacks. Accordingly, there is a great need for preventing the often visually devastating outcomes of NVG. The STRONG study is designed to test whether the topically active anti- angiogenic agent aganirsen is able to inhibit the formation of neovascularisation leading to the development of secondary NVG in eyes with iCRVO. At the same time, STRONG will provide important information on the natural course of iCRVO and NVG in a large and well- characterised cohort of such patients. Methods/ design: This protocol describes a phase II/ III, prospective, randomised, placebo- controlled, double- masked, three- armed multicentre study for the investigation of aganirsen, a new topical treatment for iCRVO in order to prevent NVG. The study will evaluate the efficacy of two different doses of this newly developed antisense oligonucleotide formulated in an eye emulsion to avoid new vessel formation by blocking insulin receptor substrate- 1 (IRS)- 1. This leads to subsequent down-regulation of both angiogenic as well as proinflammatory growth factors such as vascular endothelial growth factor (VEGF) and tumour necrosis factor (TNF). Eligible patients (n = 333) will be treated with topical aganirsen or placebo for a period of 24 weeks. They will also be invited to participate in substudies involving analysis of gonioscopic images, detection of biomarkers for NVG and risk factors for iCRVO. Discussion: The STRONG study has the potential to offer a new treatment modality for patients suffering from iCRVO with a high risk of developing NVG. The topical administration can reduce patients' burden and risk related to rescue treatment, such as destructive laser treatment or enucleation, but requires a high level of patient compliance.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Lorenz, Katrin UNSPECIFIED UNSPECIFIED UNSPECIFIED Scheller, Yvonne UNSPECIFIED UNSPECIFIED UNSPECIFIED Bell, Katharina UNSPECIFIED UNSPECIFIED UNSPECIFIED Grus, Franz UNSPECIFIED UNSPECIFIED UNSPECIFIED Ponto, Katharina A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bock, Felix UNSPECIFIED UNSPECIFIED UNSPECIFIED Cursiefen, Claus UNSPECIFIED UNSPECIFIED UNSPECIFIED Flach, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED Gehring, Marta UNSPECIFIED UNSPECIFIED UNSPECIFIED Peto, Tunde UNSPECIFIED orcid.org/0000-0001-6265-0381 UNSPECIFIED Silva, Rufino UNSPECIFIED UNSPECIFIED UNSPECIFIED Tal, Yossi UNSPECIFIED UNSPECIFIED UNSPECIFIED Pfeiffer, Norbert UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-236548
DOI:	10.1186/s13063-017-1861-3
Journal or Publication Title:	Trials
Volume:	18
Date:	2017
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1745-6215
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ENDOTHELIAL GROWTH-FACTOR; IGG ANTIBODY PATTERNS; DRY EYE PATIENTS; INTRAVITREAL BEVACIZUMAB; AUTOANTIBODY REPERTOIRES; RAPID IMPROVEMENT; SERA; AUTOIMMUNITY; PREVALENCE; EXPRESSION Multiple languages Medicine, Research & Experimental Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/23654