{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,24]],"date-time":"2025-12-24T12:44:17Z","timestamp":1766580257611,"version":"3.44.0"},"reference-count":32,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2022,7,1]],"date-time":"2022-07-01T00:00:00Z","timestamp":1656633600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open Ophth"],"accepted":{"date-parts":[[2022,6,10]]},"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To evaluate the safety and tolerability of a mineralocorticoid, in a single-dose intravitreal (IVT) injection of 1\u2009mg\/0.1\u2009mL and 2\u2009mg\/0.1\u2009mL fludrocortisone acetate (FCA) in subjects with geographical atrophy (GA) secondary to age-related macular degeneration.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and Analysis<\/jats:title>\n                  <jats:p>This phase 1b study was a two-part dose-escalation prospective study. Part 1 involved a single participant treated with 1\u2009mg\/0.1\u2009mL and monitored up to 28 days before being reviewed by a safety review committee. Two subsequent participants were then dosed with the same dose. Part 2 involved a single participant dosed with 2\u2009mg\/0.1\u2009mL and monitored up to 28 days when a further five participants were dosed. All participants were followed up for 6\u2009months after baseline.<\/jats:p>\n                  <jats:p>A full ophthalmic assessment was performed at study visits which included GA area, best-corrected visual acuity (BCVA), low-luminance BCVA (LL-BCVA) and intraocular pressure (IOP). Adverse events (AEs) were reported from the first dose of FCA until the end-of-study visit.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>There were no serious AEs (ocular or systemic) observed with IVT FCA at either 1\u2009mg\/0.1\u2009mL or 2\u2009mg\/0.1\u2009mL among nine participants. There was no evidence of increased IOP or cataract development.<\/jats:p>\n                  <jats:p>Neither BCVA or LL-BCVA changed significantly in the study-eye over the follow-up period (p=0.28\u2009and 0.38, respectively). Mean GA area increased in the study (0.5\u2009mm<jats:sup>2<\/jats:sup>, p=0.003) and fellow-eyes (0.62\u2009mm<jats:sup>2<\/jats:sup>, p=0.02) over 6\u2009months. Differences between eyes were not significant (p=0.64), and at the lower end of population norms.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>IVT FCA is clinically safe and well tolerated and did not increase IOP.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjophth-2022-001032","type":"journal-article","created":{"date-parts":[[2022,7,1]],"date-time":"2022-07-01T13:00:23Z","timestamp":1656680423000},"page":"e001032","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Phase 1B study of the safety and tolerability of the mineralocorticoid fludrocortisone acetate in patients with geographical atrophy"],"prefix":"10.1136","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2899-8832","authenticated-orcid":false,"given":"Thomas","family":"Hong","sequence":"first","affiliation":[{"name":"CUREOS, 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