{"id":378,"date":"2014-03-27T17:41:38","date_gmt":"2014-03-27T16:41:38","guid":{"rendered":"http:\/\/s519078666.onlinehome.fr\/?page_id=378"},"modified":"2018-07-02T11:33:15","modified_gmt":"2018-07-02T10:33:15","slug":"clinical-trials","status":"publish","type":"page","link":"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/","title":{"rendered":"Clinical trials"},"content":{"rendered":"<h2>Clinical trials remain rare<\/h2>\n<p>There are few clinical trials on Stargardt disease.<\/p>\n<p>They focus on different technologies: gene therapy, cell therapy, pharmacology.<\/p>\n<p>Some of these are underway.<\/p>\n<p>(updated 2018 may, <a href=\"https:\/\/www.clinicaltrials.gov\" target=\"_blank\" rel=\"noopener\">Clinical trials<\/a>)<\/p>\n<p>&nbsp;<\/p>\n<h3>Gene therapy<\/h3>\n<p><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01367444?term=stargardt&amp;rank=4\">Phase I\/IIa Study of SAR422459 in Patients With Stargardt\u2019s Macular Degeneration<\/a> (Phase I\/II* \u2013 Sponsor : Sanofi \u2013 Assay\u00a0USA and\u00a0France)<\/p>\n<p><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01736592?term=stargardt&amp;rank=5\">A Study to Determine the Long Term Safety, Tolerability and Biological Activity of SAR422459 in Patients With Stargardt\u2019s Macular Degeneration\u00a0<\/a>(Phase I\/II* \u2013 Sponsor : Sanofi \u2013 Assay\u00a0USA and\u00a0France)<\/p>\n<p><strong>Forcoming<\/strong>\u00a0: future Phase II \u00a0trial\u00ab\u00a0Gene therapy (AAV-ABCA4) to treat blindness caused by Stargardt disease\u00a0\u00bb- \u00a0Oxford University Innovation<\/p>\n<p><a href=\"http:\/\/innovation.ox.ac.uk\/licence-details\/gene-therapy-treat-blindness-caused-stargardt-disease\/\">http:\/\/innovation.ox.ac.uk\/licence-details\/gene-therapy-treat-blindness-caused-stargardt-disease\/<\/a><\/p>\n<h3>Cell therapy<\/h3>\n<p><a href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT01345006?term=stargardt&amp;rank=5\">Sub-retinal Transplantation of hESC Derived RPE(MA09-hRPE)Cells in Patients With Stargardt\u2019s Macular Dystrophy<\/a> (Phase I\/II* &#8211; Sponsor : Astellas Institute for Regenerative Medicine \u2013 Assay in USA)<\/p>\n<p><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02445612?term=stargardt&amp;rank=8\">Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Stargardt Macular Dystrophy Patients<\/a> (Phase I\/II* \u2013 Biological:\u00a0MA09-hRPE -Sponsor : Astellas Institute for Regenerative Medicine \u2013 Assay in USA)<\/p>\n<p><a href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT01469832?term=stargardt&amp;rank=9\">Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (hESC-RPE) Cells in Patients With Stargardt\u2019s Macular Dystrophy (SMD)<\/a> (Phase I\/II* \u2013 Biological:\u00a0MA09-hRPE &#8211; Sponsor : Astellas Institute for Regenerative Medicine \u2013 Assay in UK))<\/p>\n<p><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02941991?term=stargardt&amp;rank=10\">A Follow up Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (hESC-RPE) Cells in Patients With Stargardt&#8217;s Macular Dystrophy (SMD)<\/a> ( Phase I\/II- Sponsor : Astellas Institute for Regenerative Medicine \u2013 Assay in UK)<\/p>\n<h3>Pharmacology<\/h3>\n<p><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03033108\">Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Macular Atrophy Secondary to Stargardt Disease <\/a>(Phase \u00a0II \u2013 Sponsor\u00a0Acucela Inc., Assay in USA)<\/p>\n<p><a title=\"Show study NCT03364153: Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03364153?term=stargardt&amp;draw=5&amp;rank=6\">Zimura (Complement C5 Inhibitor) Compared to Sham in Patients With Autosomal Recessive\u00a0<span class=\"hit_inf\">Stargardt<\/span>\u00a0Disease (STGD1)<\/a>\u00a0\u00a0\u00a0\u00a0(Phase II -Sponsor :\u00a0Ophthotech Corporation. Assay USA)<\/p>\n<p><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01278277?term=stargardt&amp;rank=10\">Saffron Supplementation in Stargardt&#8217;s Disease<\/a> (Pase I\/II* \u2013 Sponsor\u00a0: Catholic University of the Sacred Heart &#8211; Assay in Italy)<\/p>\n<p><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT00420602?term=stargardt&amp;rank=11\">DHA Supplementation in Patients With STGD3<\/a> (Phase I\/II* ; Sponsor: University of Utah. Assay in USA)<\/p>\n<p><a title=\"Show study NCT02402660: Phase 2 Tolerability and Effects of ALK-001 on Stargardt Disease\" href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT02402660?term=stargardt&amp;rank=1\" target=\"_blank\" rel=\"noopener\">Phase 2 Tolerability and Effects of ALK-001 (C20-D3-retinyl acetate) on Stargardt Disease<\/a>\u00a0(Phase II &#8211; Sponsor :\u00a0Alkeus Pharmaceuticals, Inc. Assay in USA)<\/p>\n<h3>Other techniques<\/h3>\n<p><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01790958?term=stargardt&amp;rank=14\">Microcurrent Stimulation to Treat Macular Degeneration<\/a> <strong>( <\/strong>Sonsor\u00a0: Retina Institute of Hawaii \u2013 Assay in USA)<\/p>\n<p>&nbsp;<\/p>\n<h2>Other Studies Programs<\/h2>\n<p>&nbsp;<\/p>\n<h3>ProgStar\u00a0(<a href=\"http:\/\/progstar.org\" target=\"_blank\" rel=\"noopener\">http:\/\/progstar.org<\/a>) :<\/h3>\n<p>Sponsored by the Foundation Fighting Blindness, the Natural History of the Progression of Atrophy Secondary to Stargardt Disease (ProgStar) studies are comprised of retrospective and prospective longitudinal observational studies. The retrospective study includes clinical examination findings and images collected between 2008 (and earlier) and 2014 and progression will be retrospectively evaluated. The prospective study consists of a 24 month observational period from 2013\/2014 for two years, with one visit every six months.<\/p>\n<p>ProgStar Study :\u00a0<strong>A natural History of the progression of Stargardt Disease : retrospective and prospective Studies (Learn more &gt;\u00a0<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01977846?term=stargardt&amp;cond=%22Stargardt+Disease%22&amp;rank=3\" target=\"_blank\" rel=\"noopener\">\u00a0Clinicaltrials.gov<\/a><\/strong>).\u00a0&#8221; With the ultimate goal of determining the best outcome measures for clinical trials, the ProgStar study currently enrolls patients with\u00a0<a href=\"http:\/\/progstar.org\/progstar-home\/stargardts-disease\/\" target=\"_blank\" rel=\"noopener\">Stargardt disease type 1 (STGD1)<\/a>\u00a0caused by mutations in the ABCA4 gene.&#8221;<\/p>\n<p><em>*Phase I\/II = Safety\/Efficacy\u00a0Study<\/em><\/p>\n<p>&nbsp;<\/p>\n<h3>Publication<\/h3>\n<p>To find out more about current research, we advise you to consult the following\u00a0websites which group together many international clinical trials.<\/p>\n<ul>\n<li><strong>Clinical trials<\/strong><\/li>\n<\/ul>\n<p><a href=\"http:\/\/www.clinicaltrials.gov\/\">www.clinicaltrials.gov\/<\/a><\/p>\n<ul>\n<li><strong>Pubmed<\/strong><\/li>\n<\/ul>\n<p><a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\">http:\/\/www.ncbi.nlm.nih.gov\/pubmed<\/a><\/p>\n<p>&nbsp;<\/p>\n<div style=\"padding-bottom:20px; padding-top:10px;valign:middle;\" class=\"hupso-share-buttons\"><!-- Hupso Share Buttons - https:\/\/www.hupso.com\/share\/ --><a class=\"hupso_toolbar\" href=\"https:\/\/www.hupso.com\/share\/\"><img src=\"https:\/\/static.hupso.com\/share\/buttons\/share-medium.png\" rel=\"PrettyPhoto[378]\" style=\"border:0px; padding-top: 5px; float:left;\" alt=\"Share Button\"\/><\/a><script type=\"text\/javascript\">var hupso_services_t=new Array(\"Twitter\",\"Facebook\",\"Google Plus\",\"Linkedin\",\"Email\");var hupso_background_t=\"#EAF4FF\";var hupso_border_t=\"#66CCFF\";var hupso_toolbar_size_t=\"medium\";var hupso_image_folder_url = \"\";var hupso_url_t=\"\";var hupso_title_t=\"Clinical%20trials\";<\/script><script type=\"text\/javascript\" src=\"https:\/\/static.hupso.com\/share\/js\/share_toolbar.js\"><\/script><!-- Hupso Share Buttons --><\/div>","protected":false},"excerpt":{"rendered":"<p>Clinical trials remain rare There are few clinical trials on Stargardt disease. They focus on different technologies: gene therapy, cell therapy, pharmacology. Some of these are underway. (updated 2018 may, Clinical trials) &nbsp; Gene therapy Phase I\/IIa Study of SAR422459 in Patients With Stargardt\u2019s Macular Degeneration (Phase I\/II* \u2013 Sponsor : Sanofi \u2013 Assay\u00a0USA and\u00a0France)&#8230;<\/p>\n<div style=\"padding-bottom:20px; padding-top:10px;valign:middle;\" class=\"hupso-share-buttons\"><!-- Hupso Share Buttons - https:\/\/www.hupso.com\/share\/ --><a class=\"hupso_toolbar\" href=\"https:\/\/www.hupso.com\/share\/\"><img src=\"https:\/\/static.hupso.com\/share\/buttons\/share-medium.png\" style=\"border:0px; padding-top: 5px; float:left;\" alt=\"Share Button\"\/><\/a><script type=\"text\/javascript\">var hupso_services_t=new Array(\"Twitter\",\"Facebook\",\"Google Plus\",\"Linkedin\",\"Email\");var hupso_background_t=\"#EAF4FF\";var hupso_border_t=\"#66CCFF\";var hupso_toolbar_size_t=\"medium\";var hupso_image_folder_url = \"\";var hupso_url_t=\"\";var hupso_title_t=\"Clinical%20trials\";<\/script><script type=\"text\/javascript\" src=\"https:\/\/static.hupso.com\/share\/js\/share_toolbar.js\"><\/script><!-- Hupso Share Buttons --><\/div>","protected":false},"author":2,"featured_media":0,"parent":305,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v19.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Clinical trials<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical trials\" \/>\n<meta property=\"og:description\" content=\"Clinical trials remain rare There are few clinical trials on Stargardt disease. They focus on different technologies: gene therapy, cell therapy, pharmacology. Some of these are underway. (updated 2018 may, Clinical trials) &nbsp; Gene therapy Phase I\/IIa Study of SAR422459 in Patients With Stargardt\u2019s Macular Degeneration (Phase I\/II* \u2013 Sponsor : Sanofi \u2013 Assay\u00a0USA and\u00a0France)...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/\" \/>\n<meta property=\"og:site_name\" content=\"Stargardt Foundation\" \/>\n<meta property=\"article:modified_time\" content=\"2018-07-02T10:33:15+00:00\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.stargardt.fr\/en\/#website\",\"url\":\"https:\/\/www.stargardt.fr\/en\/\",\"name\":\"Stargardt Foundation\",\"description\":\"Work hand in hand with research\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.stargardt.fr\/en\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/\",\"url\":\"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/\",\"name\":\"Clinical trials\",\"isPartOf\":{\"@id\":\"https:\/\/www.stargardt.fr\/en\/#website\"},\"datePublished\":\"2014-03-27T16:41:38+00:00\",\"dateModified\":\"2018-07-02T10:33:15+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\/\/www.stargardt.fr\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Current Research and Trials\",\"item\":\"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Clinical trials\"}]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Clinical trials","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/","og_locale":"en_US","og_type":"article","og_title":"Clinical trials","og_description":"Clinical trials remain rare There are few clinical trials on Stargardt disease. They focus on different technologies: gene therapy, cell therapy, pharmacology. Some of these are underway. (updated 2018 may, Clinical trials) &nbsp; Gene therapy Phase I\/IIa Study of SAR422459 in Patients With Stargardt\u2019s Macular Degeneration (Phase I\/II* \u2013 Sponsor : Sanofi \u2013 Assay\u00a0USA and\u00a0France)...","og_url":"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/","og_site_name":"Stargardt Foundation","article_modified_time":"2018-07-02T10:33:15+00:00","twitter_misc":{"Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebSite","@id":"https:\/\/www.stargardt.fr\/en\/#website","url":"https:\/\/www.stargardt.fr\/en\/","name":"Stargardt Foundation","description":"Work hand in hand with research","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.stargardt.fr\/en\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/","url":"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/","name":"Clinical trials","isPartOf":{"@id":"https:\/\/www.stargardt.fr\/en\/#website"},"datePublished":"2014-03-27T16:41:38+00:00","dateModified":"2018-07-02T10:33:15+00:00","breadcrumb":{"@id":"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/clinical-trials\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/www.stargardt.fr\/en\/"},{"@type":"ListItem","position":2,"name":"Current Research and Trials","item":"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/"},{"@type":"ListItem","position":3,"name":"Clinical trials"}]}]}},"_links":{"self":[{"href":"https:\/\/www.stargardt.fr\/en\/wp-json\/wp\/v2\/pages\/378"}],"collection":[{"href":"https:\/\/www.stargardt.fr\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.stargardt.fr\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.stargardt.fr\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.stargardt.fr\/en\/wp-json\/wp\/v2\/comments?post=378"}],"version-history":[{"count":39,"href":"https:\/\/www.stargardt.fr\/en\/wp-json\/wp\/v2\/pages\/378\/revisions"}],"predecessor-version":[{"id":1178,"href":"https:\/\/www.stargardt.fr\/en\/wp-json\/wp\/v2\/pages\/378\/revisions\/1178"}],"up":[{"embeddable":true,"href":"https:\/\/www.stargardt.fr\/en\/wp-json\/wp\/v2\/pages\/305"}],"wp:attachment":[{"href":"https:\/\/www.stargardt.fr\/en\/wp-json\/wp\/v2\/media?parent=378"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}