OSLI Retina

November 2020

Issue link: http://osliretina.healio.com/i/1309207

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608 Ophthalmic Surgery, Lasers & Imaging Retina | Healio.com/OSLIRetina Practical Retina Incorporating current trials and technology into clinical practice Unsuccessful Trials That Investigated Therapies for Age-Related Macular Degeneration by Sumit Randhir Singh, MD; Arshad M. Khanani MD, MA; and Jay Chhablani, MD For our latest Practical Retina column, Sumit Randhir Singh, MD, Arshad M. Khanani MD, MA, and Jay Chhablani, MD, comment on a unique topic: a review of unsuc- cessful trials that investigated thera- pies for age-related macular degenera- tion (AMD). Successful ap- proval of only a handful of anti-vascular endothelial growth factor agents to treat wet AMD have resulted in the paradigm shift in management of wet AMD, and mil- lions of patients have benefitted from our efforts. Much attention in our lit- erature and at the podium has been fo- cused on these positive data and clini- cal trials. However, is there anything we can learn from failed trials which are only rarely discussed in our commu- nity? Perhaps a deeper analysis of why AMD trials failed can enable us to de- sign better phase 3 trials and increase the chance of approval? As the great Henry Ford said, "The only real mis- take is the one from which we learn nothing." I am certain that the valuable in- sights and review of this unique topic provided by Drs. Singh, Khanani, and Chhablani will be interesting and val- ued by our community. Age-related macular degeneration (AMD) is one of the most common causes leading to irreversible visual loss in the elderly popu- lation, with an estimated worldwide preva- lence rate of 8.69%. 1 Advanced AMD can be classified in two subtypes: geographic atro- phy (GA) and neovascular AMD in the form of choroidal neovascularization (CNV). GA is characterized by presence of outer retina and/or retinal pigment epithelium (RPE) at- rophy. Neovascular, or wet, AMD presents with subretinal fluid, hemorrhage, or intra/ subretinal fluid. Anti-vascular endothelial growth factors (VEGF) therapy have ushered an era wherein at least 50% of patients with neovascular AMD benefit with visual acu- ity (VA) of 20/40 or greater after a series of successful randomized clinical trials. 2 On the other hand, there is no approved treat- ment option available for GA. A high rate of failure, particularly trials related to GA, happened possibly due to failure to under- stand the disease pathogenesis, owing to its multifactorial origin, whereas a few recent failures stem from a faulty study design or inappropriate inclusion criteria. 3 In this article, we discuss a brief overview of the recent unsuccessful clinical trials of AMD that did not move forward or failed to get U.S. Food and Drug Administration (FDA) approvals. FOVISTA Pegpleranib, or Fovista, (E10030; Ophthotech, New York, NY) is a 32-merpegylated DNA aptamer with selective anti- platelet-derived growth factor (PDGF) action. 3,4 Following Sumit Randhir Singh Arshad M. Khanani Jay Chhablani doi: 10.3928/23258160-20201104-01 Seenu M. Hariprasad Practical Retina Co-Editor

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