The two forms of effective contraception must be implemented during the trial and for at least 90 days following the last dose of test medication. Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. Subjects of either gender aged between 18 and 50 years, inclusive. Intraocular pressure of 21 mmHg or less in the study eye. Clear ocular media and adequate pupillary dilatation in both eyes (OU) to allow for all imaging procedures, including good quality stereoscopic fundus photography, fundus autofluorescence, and spectral domain ocular coherence tomography. Fundus autofluorescence may show heterogeneous signals (areas of increased and/or decreased autofluorescence) but no area of subfoveal definitely decreased autofluorescence (DDAF). The total area of thinned layer(s) on OCT not extending beyond the outer ring of the total 9 ETDRS subfields (e.g. Presence of at least one identifiable location of at least 250 micrometers contiguous width of ellipsoid zone loss on SD-OCT within the total 9 ETDRS subfields. Best corrected visual acuity in the study eye between 20/20 - 20/200 Snellen equivalent, inclusive. At least two pathogenic mutations of ABCA4 gene confirmed by a CLIA-certified laboratory. The following inclusion criteria apply to the study eye: Los objetivos de este estudio son evaluar la seguridad y la eficacia de la inyección intravítrea de Zimura™ en comparación con un tratamiento simulado en pacientes con enfermedad de Stargardt autosómica recesiva 1 (STGD1). The objectives of this study are to evaluate the safety and efficacy of Zimura™ intravitreal injection compared to Sham in subjects with autosomal recessive Stargardt disease 1 (STGD1). Medical condition in easily understood languageĮ.1.2 Medical condition or disease under investigationġ0010331 - Congenital, familial and genetic disordersĬondition being studied is a rare disease Medicinal product containing genetically modified organismsĮ.1 Medical condition or disease under investigationĮnfermedad de Stargardt autosómica recesiva Immunological medicinal product (such as vaccine, allergen, immune serum) one involving a medical device)Ĭommittee on Advanced therapies (CAT) has issued a classification for this productĬombination product that includes a device, but does not involve an Advanced Therapy The IMP has been designated in this indication as an orphan drug in the Communityĭ.3.8 to D.3.10 IMP Identification Details (Active Substances)Īctive substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)Ĭombination ATIMP (i.e. IMP to be used in the trial has a marketing authorisation Status of the IMP to be used in the clinical trial Trial is part of a Paediatric Investigation PlanĮMA Decision number of Paediatric Investigation Plan non-technical, languageĪ Clinical Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura in Subjects with Autosomal Recessive Stargardt DiseaseĮnsayo Clínico para evaluar la seguridad y la eficacia de la administración intravítrea de Zimura en sujetos con enfermedad de Stargardt autosómica recesiva Title of the trial for lay people, in easily understood, i.e. Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (seeĪ Phase 2b Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Zimura™ (Complement C5 Inhibitor) Compared to Sham in Subjects with Autosomal Recessive Stargardt DiseaseĮstudio de fase IIb, aleatorizado, doble ciego y controlado para establecer la seguridad y la eficacia de Zimura™ (inhibidor del C5 del complemento) en comparación con un tratamiento simulado en pacientes con enfermedad de Stargardt autosómica recesiva Older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). The register also displays information on The EU Clinical Trials Register currently displaysĬlinical trials with a EudraCT protocol, of whichĪre clinical trials conducted with subjects less than 18 years old. Interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/ECĬlinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine developmentĮU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through theĬlinical Trials Information System (CTIS). Allows you to search for protocol and results information on:
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