{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T15:43:39Z","timestamp":1783784619019,"version":"3.55.0"},"reference-count":144,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T00:00:00Z","timestamp":1755734400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Exper Ophthalmology"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      To explore the prevalence of serious adverse events (\n                      <jats:styled-content style=\"fixed-case\">SAEs<\/jats:styled-content>\n                      ) associated with retinal viral gene therapy and to examine trends influencing\n                      <jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>\n                      occurrences in human gene therapy surgeries and pre\u2010clinical animal trials.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Literature review was performed to identify peer\u2010reviewed human and animal studies relevant to viral gene therapy, subretinal injections, and intravitreal injections. For clinical trials and post\u2010approval\n                      <jats:styled-content style=\"fixed-case\">LUXTURNA<\/jats:styled-content>\n                      studies, only those that examined\n                      <jats:styled-content style=\"fixed-case\">SAEs<\/jats:styled-content>\n                      were included.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of included clinical trial studies (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200931),\n                      <jats:styled-content style=\"fixed-case\">SAEs<\/jats:styled-content>\n                      were recorded in 51 out of 438 eyes (11.6%) that received subretinal injections and in 11 out of 348 eyes (3.2%) that received intravitreal injections. There were fewer intravitreal\u2010related\n                      <jats:styled-content style=\"fixed-case\">SAEs<\/jats:styled-content>\n                      and less vision loss compared to subretinal gene therapy. Inflammation was the predominant\n                      <jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>\n                      following intravitreal injections, whereas unexplained vision loss was the most common for subretinal injections. Clinical trials utilising subretinal injections met primary or secondary efficacy endpoints more than intravitreal trials. Eighteen studies (429 eyes) of post\u2010approval\n                      <jats:styled-content style=\"fixed-case\">LUXTURNA<\/jats:styled-content>\n                      were reviewed, and\n                      <jats:styled-content style=\"fixed-case\">SAEs<\/jats:styled-content>\n                      were reported in 24.7% of eyes, retinal degeneration being most common (20.7%). For 58 animal studies,\n                      <jats:styled-content style=\"fixed-case\">SAEs<\/jats:styled-content>\n                      were recorded in 17.3% of eyes that received subretinal injections and 8.7% of eyes that received intravitreal injections.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Subretinal injections show higher efficacy than intravitreal injections but are associated with more serious adverse events. Consistent adverse event patterns in humans and large animals highlight their predictive value for safety. There is a need for optimised delivery methods, refined dosing protocols, and improved post\u2010treatment monitoring to improve safety and effectiveness in gene therapy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/ceo.14593","type":"journal-article","created":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T23:35:16Z","timestamp":1755819316000},"page":"967-985","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Retinal Viral Gene Therapy: Impact of Route of Administration on Serious Adverse Events\u2014A Systematic Review"],"prefix":"10.1111","volume":"53","author":[{"given":"Aubrey","family":"Berger","sequence":"first","affiliation":[{"name":"Biomedical Graduate Program, Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ciera D.","family":"Johnson","sequence":"additional","affiliation":[{"name":"University of Minnesota Medical School  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan D.","family":"Marmorstein","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8806-1438","authenticated-orcid":false,"given":"Brittni A.","family":"Scruggs","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,8,21]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms232113467"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.preteyeres.2021.101029"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.21037\/atm-20-4726"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)31868-8"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2023.12.033"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41433-018-0138-8"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40942-021-00307-7"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2019.04.037"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.oret.2020.09.024"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2011.08.011"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/eye.2013.107"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajoc.2022.101677"},{"key":"e_1_2_9_14_1","first-page":"2","article-title":"Sterile Endophthalmitis After Intravitreal Injection of Triamcinolone Acetonide: Case Report and Literature Review","volume":"68","author":"Beuran D. 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