{"id":45950,"date":"2023-04-03T00:04:26","date_gmt":"2023-04-03T04:04:26","guid":{"rendered":"https:\/\/reviewofmm.com\/?p=45950"},"modified":"2023-03-30T10:41:42","modified_gmt":"2023-03-30T14:41:42","slug":"myopia-control-clinical-trials-time-for-a-change","status":"publish","type":"post","link":"https:\/\/reviewofmm.com\/myopia-control-clinical-trials-time-for-a-change\/","title":{"rendered":"Myopia Control Clinical Trials: Time for a Change?"},"content":{"rendered":"<p><strong>April 3, 2023<\/strong><\/p>\n<p><strong>By Dwight Akerman, OD, MBA, FAAO, FBCLA, FIACLE<\/strong><\/p>\n<p><span style=\"font-weight: 400;\"><img decoding=\"async\" loading=\"lazy\" class=\"alignright wp-image-35546\" src=\"https:\/\/reviewofmm.com\/wp-content\/uploads\/2020\/05\/GettyImages-1180547354-300x164.jpg\" alt=\"Myopia control clinical trials\" width=\"395\" height=\"216\" srcset=\"https:\/\/reviewofmm.com\/wp-content\/uploads\/2020\/05\/GettyImages-1180547354-300x164.jpg 300w, https:\/\/reviewofmm.com\/wp-content\/uploads\/2020\/05\/GettyImages-1180547354-1024x561.jpg 1024w, https:\/\/reviewofmm.com\/wp-content\/uploads\/2020\/05\/GettyImages-1180547354-768x421.jpg 768w, https:\/\/reviewofmm.com\/wp-content\/uploads\/2020\/05\/GettyImages-1180547354-1536x841.jpg 1536w, https:\/\/reviewofmm.com\/wp-content\/uploads\/2020\/05\/GettyImages-1180547354-2048x1122.jpg 2048w\" sizes=\"(max-width: 395px) 100vw, 395px\" \/>Eye care practitioners can prescribe several therapies for slowing progression in children and adolescents. Currently, no monotherapy has been shown in randomized controlled trials (RCTs) to stop myopia progression completely. Therefore, research continues to discover more efficacious interventions.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The complexity, length, and cost of myopia clinical trials for regulatory approval can be challenging, especially for start-up companies. The U.S. Food and Drug Administration (FDA) currently requires a three-year RCT. However, the regulatory bar appears more reasonable in other markets such as the European Union, Canada, and Australia\/New Zealand. An interesting complication for myopia control is that both medical devices and pharmacological treatments slow the progression of childhood myopia. It remains uncertain how the FDA will approach comparisons of myopic control devices and myopia control pharmacological interventions as different groups currently review them within the FDA.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">As the regulatory pathway to obtain the coveted \u201cmyopia progression control\u201d labeling indication can be lengthy, some treatments have entered clinical practice before regulatory approval through peer-reviewed papers of academic investigator-led trials. The availability of on-label and off-label myopia control therapies creates challenges for conducting placebo-controlled RCTs, including ethics, recruitment, retention, selective loss of faster progressors, and non-protocol treatments.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The authors propose that future myopia control clinical trials may adopt one of the following designs:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">non-inferiority trials<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">short-term conventional efficacy trials<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">virtual control group trials<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">short-term control data from a cohort<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">time-to-treatment-failure trials<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The authors conclude that the failure to rethink the design of myopia control clinical trials may impede innovation and, ultimately, patient care.<\/span><\/p>\n<p><b>Abstract<\/b><\/p>\n<p><b>The Future of Clinical Trials of Myopia Control\u00a0<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Mark A Bullimore<\/span><span style=\"font-weight: 400;\">,\u00a0<\/span><span style=\"font-weight: 400;\">Noel A Brennan<\/span><span style=\"font-weight: 400;\">,\u00a0<\/span><span style=\"font-weight: 400;\">Daniel Ian Flitcroft<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In the field of myopia control, effective optical or pharmaceutical therapies are now available to patients in many markets. This creates challenges for the conduct of placebo-controlled, randomized clinical trials, including ethics, recruitment, retention, selective loss of faster progressors, and non-protocol treatments:\u00a0<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ethics: It is valid to question whether withholding treatment in control subjects is ethical.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Recruitment: Availability of treatments is making recruitment into clinical trials more difficult.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Retention: If masking is not possible, parents may immediately withdraw their child if randomized to no treatment.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Selective loss: Withdrawal of fast progressors in the control group leading to a control group biased towards low progression.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Non-protocol treatment: Parents may access other myopia treatments in addition to those within the trial.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">We propose that future trials may adopt one of the following designs:\u00a0<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Non-inferiority trials using an approved drug or device as the control. The choice will depend on whether a regulatory agency has approved the drug or device.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Short conventional efficacy trials where data are subsequently entered into a model created from previous clinical trials, which allows robust prediction of long-term treatment efficacy from the initial efficacy.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Virtual control group trials based on data relating to axial elongation, myopia progression or both, accounting for subject&#8217;s age and race.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Short-term control data from a cohort, for example, one\u2009year or less, and applying an appropriate, proportional annual reduction in axial elongation to that population and extrapolating to subsequent years.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Time-to-treatment-failure trials using survival analysis; once a treated or control subject progresses or elongates by a given amount, they exit the study and can be offered treatment.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">In summary, the future development of new treatments in myopia control will be hampered if significant changes are not made to the design of clinical trials in this area.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Bullimore MA, Brennan NA, Flitcroft DI. The future of clinical trials of myopia control. Ophthalmic Physiol Opt. 2023 Mar 10. Epub ahead of print. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">DOI: <\/span><strong><a href=\"https:\/\/doi.org\/10.1111\/opo.13120\" target=\"_blank\" rel=\"noopener\">https:\/\/doi.org\/10.1111\/opo.13120<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>April 3, 2023 By Dwight Akerman, OD, MBA, FAAO, FBCLA, FIACLE Eye care practitioners can prescribe several therapies for slowing progression in children and adolescents. Currently, no monotherapy has been shown in randomized controlled trials (RCTs) to stop myopia progression completely. Therefore, research continues to discover more efficacious interventions. The complexity, length, and cost of myopia clinical trials for regulatory approval can be challenging, especially for start-up companies. The U.S. Food and Drug Administration (FDA) currently requires a three-year RCT. However, the regulatory bar appears more reasonable in other markets such as the European Union, Canada, and Australia\/New Zealand. An interesting complication for myopia control is that both medical devices and pharmacological treatments slow the progression of childhood myopia. It remains uncertain how the FDA will approach comparisons of myopic control devices and myopia control pharmacological interventions as different groups currently review them within the FDA.\u00a0 As the regulatory pathway to obtain the coveted \u201cmyopia progression control\u201d labeling indication can be lengthy, some treatments have entered clinical practice before regulatory approval through peer-reviewed papers of academic investigator-led trials. The availability of on-label and off-label myopia control therapies creates challenges for conducting placebo-controlled RCTs, including ethics, recruitment, retention, selective loss of faster progressors, and non-protocol treatments.\u00a0 The authors propose that future myopia control clinical trials may adopt one of the following designs: non-inferiority trials short-term conventional efficacy trials virtual control group trials short-term control data from a cohort time-to-treatment-failure trials The authors conclude that the failure to rethink the design of myopia control clinical trials may impede innovation and, ultimately, patient care. Abstract The Future of Clinical Trials of Myopia Control\u00a0 Mark A Bullimore,\u00a0Noel A Brennan,\u00a0Daniel Ian Flitcroft\u00a0 In the field of myopia control, effective optical or pharmaceutical therapies are now available to patients in many markets. This creates challenges for the conduct of placebo-controlled, randomized clinical trials, including ethics, recruitment, retention, selective loss of faster progressors, and non-protocol treatments:\u00a0 Ethics: It is valid to question whether withholding treatment in control subjects is ethical. Recruitment: Availability of treatments is making recruitment into clinical trials more difficult. Retention: If masking is not possible, parents may immediately withdraw their child if randomized to no treatment. Selective loss: Withdrawal of fast progressors in the control group leading to a control group biased towards low progression. Non-protocol treatment: Parents may access other myopia treatments in addition to those within the trial. We propose that future [&hellip;]<\/p>\n","protected":false},"author":258,"featured_media":35546,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1623],"tags":[2105,1106,1791,1943,452,698,4364,1067,1584,2130,558,2107,1617,1618],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Myopia Control Clinical Trials: Time for a Change? - Review of Myopia Management<\/title>\n<meta name=\"description\" content=\"In this research review, Dr. Akerman examines the current structure of myopia control clinical trials and how to update them.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/reviewofmm.com\/myopia-control-clinical-trials-time-for-a-change\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta 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