ABSTRACT
RATIONALE: The bullous variant of central serous chorioretinopathy (CSC) is a severe form of chronic CSC. Patients with the bullous variant of CSC have an increased risk of experiencing multiple pigment epithelial detachments (PEDs) and retinal pigment epithelium (RPE) tears. Photodynamic therapy (PDT) is a treatment for the bullous variant of CSC. RPE tear is a possible postoperative complication of PDT for eyes with PEDs. To our knowledge, no cases of giant RPE tears following PDT for the bullous variant of CSC have been reported previously. This case report presents the first instance of a giant RPE tear after half-time PDT for the bullous variant of CSC, accompanied by a series of images depicting the tear development. PATIENT CONCERNS: A 63-year-old male patient presented with rapidly deteriorating vision in his left eye over a 3-month period. He also reported a previous episode of vision loss in his right eye 2 years prior. Best-corrected visual acuity (BCVA) in the left eye was 0.2. DIAGNOSIS: The right eye was diagnosed with chronic non-bullous CSC, while the left eye was diagnosed with the bullous variant of CSC with a large PED. INTERVENTIONS: Half-time PDT was administered to the left eye. OUTCOMES: One month after half-time PDT, a giant RPE tear exceeding 3 clock-hours in size was confirmed in the lower temporal quadrant of the left eye. Three months after the initial half-time PDT, a second half-time PDT was performed owing to recurrent retinal detachment. Two months after the second half-time PDT, the retinal detachment resolved, and BCVA improved to 0.4, 6 months after the second half-time PDT. LESSONS: In cases where the bullous variant of CSC is complicated by extensive PED, clinicians should consider the potential development of a giant RPE tear as a treatment complication.
Subject(s)
Central Serous Chorioretinopathy , Photochemotherapy , Retinal Detachment , Retinal Perforations , Male , Humans , Middle Aged , Central Serous Chorioretinopathy/chemically induced , Central Serous Chorioretinopathy/drug therapy , Central Serous Chorioretinopathy/complications , Retinal Detachment/etiology , Photochemotherapy/adverse effects , Photochemotherapy/methods , Visual Acuity , Retinal Perforations/surgery , Retinal Perforations/complications , Fluorescein Angiography , Retinal Pigments/therapeutic use , Tomography, Optical Coherence , Photosensitizing Agents/adverse effects , Retrospective StudiesABSTRACT
This report describes a case of bilateral, simultaneous central serous chorioretinopathy (CSCR) in a young woman on oral contraceptive pills (OCP). A 21-year-old woman with a negative past medical history presented with sudden onset of bilateral decreased vision shortly after starting OCP. Comprehensive ocular examination revealed bilateral central serous chorioretinopathy (CSCR), confirmed on retinal optical coherence tomography (OCT) and intravenous fluorescein angiography. The patient was instructed to discontinue OCP, and three weeks later, there was complete resolution of the visual symptoms and of the bilateral serous retinal detachments, documented on OCT. [Ophthalmic Surg Lasers Imaging Retina 2024;55:96-99.].
Subject(s)
Central Serous Chorioretinopathy , Retinal Detachment , Female , Humans , Young Adult , Adult , Central Serous Chorioretinopathy/chemically induced , Central Serous Chorioretinopathy/diagnosis , Retina , Retinal Detachment/diagnosis , Fluorescein Angiography , Tomography, Optical Coherence/methods , ContraceptionABSTRACT
BACKGROUND Central serous chorioretinopathy (CSCR) involves a localized serous macular detachment, secondary to retinal pigment epithelial and choroidal vascular changes, which can be an adverse effect of corticosteroid use. Most CSCR cases resolve spontaneously, and normal vision returns, while some chronic cases can result in blindness. This report is of a 30-year-old man with a recent history of Corona virus disease (COVID)-19 requiring corticosteroid treatment who developed bilateral CSCR with unilateral fibrin and a 7-month follow-up. CASE REPORT A 30-year-old male patient presented with malaise and high fever. The patient tested positive for COVID-19, caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus and was admitted. During hospitalization, he received intravenous (IV) corticosteroids for 1 week (6 mg dexamethasone IV once daily). Following hospitalization, the patient received per os methylprednisolone 16 mg (16 mg once daily for 3 days, 8 mg once daily for 3 days, 4 mg once daily for 3 days, and 2 mg once daily for 3 days). One month later, the patient presented with bilateral visual acuity (VA) deterioration and acute CSCR. The diagnosis and follow-up were performed by optical coherence tomography (OCT) and fundus fluorescein angiography (FFA). The patient was followed-up for a period of 7 months, during which, although the VA improved and remained stable, the OCT findings were changing. CONCLUSIONS This report highlights the importance of timely ophthalmological examination in patients with sudden vision loss and identification of the association between corticosteroid use and CSCR, as well as the importance of a longer follow-up period.
Subject(s)
COVID-19 , Central Serous Chorioretinopathy , Male , Humans , Adult , Central Serous Chorioretinopathy/chemically induced , Central Serous Chorioretinopathy/diagnosis , Central Serous Chorioretinopathy/drug therapy , Follow-Up Studies , COVID-19/complications , SARS-CoV-2 , Fluorescein Angiography , Adrenal Cortex Hormones , Tomography, Optical Coherence/methodsABSTRACT
BACKGROUND: Corticosteroids are widely used in medicine. Few cases of central serous chorioretinopathy (CSC) have been reported following topical corticosteroid administration. We describe the first case of pediatric CSC related to topical corticosteroid administration. CASE PRESENTATION: A 14-year-old boy presented with decreased vision, pigment epithelial detachments, and serous retinal detachments in the right eye after starting treatment for atopic dermatitis with Betamethasone Valerate 0.1% topical ointment. His condition resolved 2 weeks after discontinuing the steroid and administering Bromfenac 0.9 mg/ml eyedrops. CONCLUSIONS: Although the pathogenesis of CSC is poorly understood, ophthalmologists should be informed about the potential link between CSC and topical corticosteroid treatment, and they should be aware that CSC might, albeit infrequently, affect children.
Subject(s)
Central Serous Chorioretinopathy , Retinal Detachment , Male , Humans , Child , Adolescent , Central Serous Chorioretinopathy/chemically induced , Central Serous Chorioretinopathy/diagnosis , Central Serous Chorioretinopathy/drug therapy , Retinal Detachment/complications , Glucocorticoids/therapeutic use , Adrenal Cortex Hormones , SteroidsABSTRACT
Purpose: To explore the temporal topography of the chorioretinopathy in an animal model of central serous chorioretinopathy (CSC) induced by intravenous injection of adrenalin in the Chinchilla rabbits. Methods: Ten Chinchilla rabbits received a daily intravenous injection of adrenaline at 0.04 mg/kg for 8 weeks. Fluorescence fundus angiography (FFA) and electroretinogram (ERG) were performed every week afterwards to see whether there was fluorescence leakage in the fundus and to evaluate the retinal function. Indocyanine green angiography (ICGA) and optical coherence tomography (OCT) were also conducted to detect the change of choroidal vessels. Finally, the eyes of the rabbits were enucleated to make the retinal sections for histological examination with hematoxylin-eosin (HE) staining. Results: Within 8 weeks of the adrenalin administration, 7 out of the 10 rabbits showed different degrees of fluorescence leakage on FFA. The leakage was more obvious during 2-3 weeks after the adrenalin administration. With the progress of disease, the leakage subsided gradually and a scar-like lesion formed. ICGA revealed the local choroidal ischemia and the dilated choroidal vessels. An obvious detachment of retina and an increased thickness of the choroid were found on OCT, which was most obvious 2 weeks after the adrenalin administration (P<0.01). ERG revealed no obvious decline of the b-wave amplitude before and after the adrenalin administration (P>0.05). A circumscribed retinal detachment, the depigmentation of retinal pigment epithelium and enlarged choroidal vessels were shown by the histological examination. Conclusion: The temporal topography of the chorioretinopathy in the Chinchilla rabbits by intravenous injection of adrenaline somewhat mimicked that of the human CSC, which could enhance its application in the exploration for the pathogenesis and the therapeutic measures for human CSC.
Subject(s)
Central Serous Chorioretinopathy , Animals , Central Serous Chorioretinopathy/chemically induced , Central Serous Chorioretinopathy/diagnosis , Central Serous Chorioretinopathy/drug therapy , Choroid , Eosine Yellowish-(YS)/therapeutic use , Epinephrine/therapeutic use , Fluorescein Angiography/methods , Hematoxylin/therapeutic use , Humans , Indocyanine Green , Injections, Intravenous , Rabbits , Tomography, Optical Coherence/methodsABSTRACT
Central serous chorioretinopathy (CSC) is a common chorioretinal disorder. It has been postulated that impaired retinal pigment epithelium and hyperpermeability of the choriocapillaris may be involved in the development of CSC, but the exact pathomechanism has not been established. We report an unusual case of a middle-aged man who developed CSC after triamcinolone acetonide injection for macular edema. Edema developed as a late complication of radiation retinopathy after brachytherapy for childhood retinoblastoma. Steroid treatment is an important risk factor for CSC, but the underlying causative mechanisms have not been fully elucidated. It is important to increase the awareness of this link among clinicians who prescribe exogenous corticosteroids, irrespective of the route of administration.
Subject(s)
Central Serous Chorioretinopathy , Adrenal Cortex Hormones/adverse effects , Central Serous Chorioretinopathy/chemically induced , Central Serous Chorioretinopathy/complications , Child , Choroid , Glucocorticoids , Humans , Male , Middle Aged , Retinal Pigment Epithelium , Tomography, Optical CoherenceABSTRACT
INTRODUCTION: A 43-year-old Caucasian male presented to our ophthalmology clinic with blurry vision and metamorphopsia in his right eye, 24 hours after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine. METHODS: Clinical examination and imaging tests were consistent with acute unilateral central serous chorioretinopathy (CSCR) that completely resolved after 2 months without any treatment. He had no significant ophthalmic or medical history. He also lacked the classical risk factors for CSCR such as recent psychosocial stressors, Type-A personality traits, history of exogenous steroid use, connective tissue disorders and obstructive sleep apnea. RESULTS: This appears to be only the second reported case of CSCR, temporally associated with a recombinant COVID-19 mRNA vaccine. We also present a summary of published reports demonstrating intraocular complications associated with the novel recombinant COVID-19 mRNA vaccines. CONCLUSION: Findings in this report should not deter COVID-19 vaccinations given the rarity of aforementioned ocular complications and the greater benefit of protection from COVID-19 infection. Medical practitioners, however, should remain mindful of potential ocular complications, given the greater likelihood of occurrence with increasing vaccination booster rates.
Subject(s)
BNT162 Vaccine , COVID-19 , Central Serous Chorioretinopathy , Acute Disease , Adult , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , Central Serous Chorioretinopathy/chemically induced , Central Serous Chorioretinopathy/diagnosis , Humans , Male , Vaccination/adverse effects , Vision Disorders/diagnosisSubject(s)
Central Serous Chorioretinopathy , Neuromyelitis Optica , Central Serous Chorioretinopathy/chemically induced , Central Serous Chorioretinopathy/diagnostic imaging , Humans , Neuromyelitis Optica/complications , Neuromyelitis Optica/diagnostic imaging , Neuromyelitis Optica/drug therapy , Steroids/adverse effectsABSTRACT
We present a case of acute bilateral multifocal CSCR in a young healthy Caucasian female occurring 3 days after receiving the first dose of the Pfizer-BioNTech BNT162b2 COVID-19 mRNA vaccine. The true incidence of this adverse reaction might be underreported in asymptomatic unilateral or paracentral cases. We believe that the post-COVID-19 vaccination occurrence of CSCR is not a sufficient reason to withhold the second dose of the vaccine. Further studies are required to ascertain the best way to prevent and manage this complication.
Subject(s)
BNT162 Vaccine , COVID-19 , Central Serous Chorioretinopathy , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , Central Serous Chorioretinopathy/chemically induced , Female , HumansABSTRACT
Mitogen-activated protein kinase kinase (MEK) inhibitors have significantly improved the prognosis of various types of cancer such as metastatic melanoma. However, their use is usually associated with ocular side effects. A retinopathy associated with these agents (MEKAR) has been described, consisting of the development of neurosensory detachments, generally bilateral and multiple, similar to those that appear in the central serous chorioretinopathy (CSC). Generally, optical coherence tomography allows us to differentiate the two conditions. We present the case of a 55-year-old woman in treatment with a MEK inhibitor, who developed bilateral neurosensory detachments and blurred vision, which resolved with the discontinuance of the treatment due to tumour progression.
Subject(s)
Central Serous Chorioretinopathy , Melanoma , Central Serous Chorioretinopathy/chemically induced , Female , Humans , Melanoma/pathology , Middle Aged , Mitogen-Activated Protein Kinase Kinases/therapeutic use , Mitogen-Activated Protein Kinases , Protein Kinase Inhibitors/adverse effectsABSTRACT
INTRODUCTION: Cutaneous melanoma is a malignant tumor, which develops from dermal melanocytes. Targeted therapies have changed the therapeutic management of metastatic melanoma and improved the survival rate. Among the various targeted therapies, MEK inhibitors and BRAF inhibitors have demonstrated efficacy, but they may lead to ocular toxicity. The goal of this study was to assess the incidence of ocular complications caused by the use of MEK inhibitors and BRAF inhibitors and to report their clinical features and therapeutic management. MATERIAL AND METHODS: This retrospective, observational, descriptive, single center study was conducted between May 2015 and December 2019 and included all patients with metastatic cutaneous melanomas treated with MEK inhibitors and BRAF inhibitors in whom ophthalmic toxicity was suspected. The data collected were demographic data (age, sex), the type of MEK inhibitors and BRAF inhibitors used, the length of time from melanoma diagnosis, mean duration of ophthalmological follow-up, time differential between starting therapy and the emergence of ocular complications, initial and final logMAR visual acuity, biomicroscopic examination of the anterior segment, dilatated fundus examination, and treatment administered. RESULTS: Fifty-four eyes of 27 patients with a mean age of 61.3±14.3 were included. The mean time delay between melanoma diagnosis and initiation of treatment was 23.2±8 months. Twenty patients (74%) were treated with a combination of MEK inhibitors and BRAF inhibitors (trametinib/dabrafenib), 5 patients (19%) were treated with MEK inhibitor monotherapy (cobimetinib), and 2 patients (7%) were treated with BRAF inhibitor monotherapy (vemurafenib). The mean duration of ophthalmological follow-up was 77.8±29 days, and the delay between the start of therapy and the emergence of symptoms was 87.2±78 days. The mean initial visual acuity was 0.075±0.13 logMAR, and the final visual acuity was 0.01±0.03 logMAR. Twelve patients (44%) developed ocular complications due to the targeted therapy. In the patients who received combination trametinib/dabrafenib, 5 patients (18.5%) developed clinical signs of uveitis, from acute anterior uveietis to panuveitis, and 2 patients (7.4%) developed bilateral central serous chorioretinopathy; in the patients who received cobimetinib, 4 patients (14.8%) developed bilateral central serous chorioretinopathy; and one patient (3.7%) who received vemurafenib developed acute anterior uveitis. For these 12 patients with ophthalmic side effects, temporary discontinuation of therapy was chosen for six patients (22.2%), three patients (11.1%) received half the initial dose, and for three patients (11.1%), normal dosing was continued. CONCLUSION: The two main side effects of targeted therapies are uveitis for BRAF inhibitors and central serous chorioretinopathy for MEK inhibitors. A multidisciplinary approach including ophthalmologists, dermatologists and oncologists is essential in order to adapt treatment in the advent of these ocular complications.
Subject(s)
Central Serous Chorioretinopathy , Melanoma , Skin Neoplasms , Uveitis , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Central Serous Chorioretinopathy/chemically induced , Humans , Melanoma/drug therapy , Melanoma/pathology , Middle Aged , Mitogen-Activated Protein Kinase Kinases/therapeutic use , Protein Kinase Inhibitors/adverse effects , Proto-Oncogene Proteins B-raf/genetics , Proto-Oncogene Proteins B-raf/therapeutic use , Retrospective Studies , Skin Neoplasms/drug therapy , Skin Neoplasms/pathology , Toxic Optic Neuropathy , Uveitis/etiology , Vemurafenib , Melanoma, Cutaneous MalignantABSTRACT
BACKGROUND AND PURPOSE: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has accelerated vaccine development. The BNT162b2 messenger RNA (mRNA) vaccine is being administered worldwide. The purpose of this case series is to report a possible association between the BNT162b2 mRNA vaccine and Central serous chorioretinopathy (CSC). Although rare, CSC has been reported following the administration of anthrax, influenza and smallpox vaccines. METHODS: Four individuals who developed CSC following the BNT162b2 mRNA vaccine were examined in our institution using multimodal imaging of the retina, and their demographic data were analyzed and compared to all the similar cases published to date. RESULTS: Four patients (3 males, 1 female) between the ages of 35 and 65 presented with acute CSC (n=3) and relapsed CSC (n=1) within the first week following the administration of the BNT162b2 mRNA vaccine. Three individuals demonstrated hyper-reflective foci in the outer segments of the retina. CONCLUSIONS: The timing of the BNT162b2 mRNA vaccine administration relative to the development of CSC suggests a possible causal relationship. Further research is necessary to explore this possible association.
Subject(s)
BNT162 Vaccine , COVID-19 , Central Serous Chorioretinopathy , Adult , Aged , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , Central Serous Chorioretinopathy/chemically induced , Female , Humans , Male , Middle Aged , SARS-CoV-2ABSTRACT
Central serous chorioretinopathy (CSC) is a vision-threatening disease with no validated treatment and unclear pathogenesis. It is characterized by dilation and leakage of choroidal vasculature, resulting in the accumulation of subretinal fluid, and serous detachment of the neurosensory retina. Numerous studies have demonstrated that melatonin had multiple protective effects against endothelial dysfunction, vascular inflammation, and blood-retinal barrier (BRB) breakdown. However, the effect of melatonin on CSC, and its exact pathogenesis, is not well understood thus far. In this study, an experimental model was established by intravitreal injection of aldosterone in rats, which mimicked the features of CSC. Our results found that melatonin administration in advance significantly inhibited aldosterone-induced choroidal thickening and vasodilation by reducing the expression of calcium-activated potassium channel KCa2.3, and attenuated tortuosity of choroid vessels. Moreover, melatonin protected the BRB integrity and prevented the decrease in tight junction protein (ZO-1, occludin, and claudin-1) levels in the rat model induced by aldosterone. Additionally, the data also showed that intraperitoneal injection of melatonin in advance inhibited aldosterone-induced macrophage/microglia infiltration, and remarkably diminished the levels of inflammatory cytokines (interleukin-6 [IL-6], IL-1ß, and cyclooxygenase-2), chemokines (chemokine C-C motif ligand 3, and C-X-C motif ligand 1), and matrix metalloproteinases (MMP-2 and MMP-9). Luzindole, as the nonselective MT1 and MT2 antagonist, and 4-phenyl-2-propionamidotetraline, as the selective MT2 antagonist, neutralized the melatonin-induced inhibition of choroidal thickening and choroidal vasodilation, indicating that melatonin might exert the effects via binding to its receptors. Furthermore, the IL-17A/nuclear factor-κB signaling pathway was activated by intravitreal administration of aldosterone, while it was suppressed in melatonin-treated in advance rat eyes. This study indicates that melatonin could serve as a promising safe therapeutic strategy for CSC patients.
Subject(s)
Central Serous Chorioretinopathy , Melatonin , Aldosterone/therapeutic use , Animals , Central Serous Chorioretinopathy/chemically induced , Central Serous Chorioretinopathy/drug therapy , Choroid/blood supply , Ligands , Melatonin/pharmacology , Melatonin/therapeutic use , RatsABSTRACT
Corticosteroid-induced central serous chorioretinopathy (CSCR) has been reported to develop in many intraocular inflammatory diseases and usually resolves spontaneously after discontinuation of corticosteroids. Patients without any improvement may require alternative therapies. In this case report, we present the case of a 35-year-old man with Behçet's disease who had complaints of decreased vision due to CSCR in his left eye while using systemic corticosteroids along with cyclosporine and azathioprine. Half-fluence photodynamic therapy (PDT) was performed because the CSCR did not regress despite discontinuation of systemic corticosteroids. After treatment, his visual acuity increased with complete resolution of the subfoveal fluid. Half-fluence PDT seems to be an effective and safe treatment for patients who develop acute CSCR while under systemic or local corticosteroid therapy for intraocular inflammatory diseases such as Behçet's uveitis and do not improve despite steroid discontinuation.
Subject(s)
Behcet Syndrome , Central Serous Chorioretinopathy , Photochemotherapy , Uveitis , Adrenal Cortex Hormones/therapeutic use , Adult , Behcet Syndrome/complications , Behcet Syndrome/diagnosis , Behcet Syndrome/drug therapy , Central Serous Chorioretinopathy/chemically induced , Central Serous Chorioretinopathy/diagnosis , Central Serous Chorioretinopathy/drug therapy , Fluorescein Angiography , Humans , Male , Photochemotherapy/adverse effects , Photosensitizing Agents/adverse effects , Tomography, Optical Coherence , Uveitis/drug therapy , Verteporfin/therapeutic useABSTRACT
PURPOSE: To describe the incidence and characteristics of photodynamic therapy-induced acute exudative maculopathy (PAEM) and bacillary layer detachment in patients with chronic central serous chorioretinopathy. METHODS: This was a prospective observational case series including 92 eyes of 75 patients who underwent photodynamic therapy. Best-corrected visual acuity, optical coherence tomography, and optical coherence tomography angiography were performed before, 3 days, 1 month, and 3 months after half-fluence photodynamic therapy. Two groups were established depending on the presence or absence (N = 28 and N = 64, respectively) of PAEM. Choriocapillaris flow voids increase, subfoveal choroidal thickness, and the presence of choroidal neovascularization were collected. RESULTS: The incidence of PAEM was 28/92 (30.4%). There was no difference in the age, sex, baseline subretinal fluid, subfoveal choroidal thickness, or the presence of choroidal neovascularization between groups (P ≥ 0.094). No differences emerged in the subretinal fluid at 1 and 3 months after photodynamic therapy between groups (P ≥ 0.524), nor in the mean best-corrected visual acuity gain at 3 months (4.1 ± 7.6 vs. 3.6 ± 6.4 letters; P = 0.773). A bacillary layer detachment was observed in 13 patients with PAEM (46.4%). CONCLUSION: Photodynamic therapy-induced acute exudative maculopathy is frequent in patients with chronic central serous chorioretinopathy but has a favorable prognosis. There was no association between PAEM and age, sex, subfoveal choroidal thickness, or choroidal neovascularization; however, it was related to choriocapillaris flow voids increase.
Subject(s)
Bacillus , Central Serous Chorioretinopathy , Choroidal Neovascularization , Macular Degeneration , Photochemotherapy , Central Serous Chorioretinopathy/chemically induced , Central Serous Chorioretinopathy/complications , Central Serous Chorioretinopathy/diagnosis , Choroidal Neovascularization/diagnosis , Choroidal Neovascularization/drug therapy , Fluorescein Angiography , Humans , Macular Degeneration/drug therapy , Photochemotherapy/adverse effects , Photochemotherapy/methods , Photosensitizing Agents/adverse effects , Verteporfin/therapeutic use , Visual AcuityABSTRACT
BACKGROUND: Erdafitinib, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, was shown to be clinically active and tolerable in patients with advanced urothelial carcinoma and prespecified FGFR alterations in the primary analysis of the BLC2001 study at median 11 months of follow-up. We aimed to assess the long-term efficacy and safety of the selected regimen of erdafitinib determined in the initial part of the study. METHODS: The open-label, non-comparator, phase 2, BLC2001 study was done at 126 medical centres in 14 countries across Asia, Europe, and North America. Eligible patients were aged 18 years or older with locally advanced and unresectable or metastatic urothelial carcinoma, at least one prespecified FGFR alteration, an Eastern Cooperative Oncology Group performance status of 0-2, and progressive disease after receiving at least one systemic chemotherapy or within 12 months of neoadjuvant or adjuvant chemotherapy or were ineligible for cisplatin. The selected regimen determined in the initial part of the study was continuous once daily 8 mg/day oral erdafitinib in 28-day cycles, with provision for pharmacodynamically guided uptitration to 9 mg/day (8 mg/day UpT). The primary endpoint was investigator-assessed confirmed objective response rate according to Response Evaluation Criteria In Solid Tumors version 1.1. Efficacy and safety were analysed in all treated patients who received at least one dose of erdafitinib. This is the final analysis of this study. This study is registered with ClinicalTrials.gov, NCT02365597. FINDINGS: Between May 25, 2015, and Aug 9, 2018, 2328 patients were screened, of whom 212 were enrolled and 101 were treated with the selected erdafitinib 8 mg/day UpT regimen. The data cutoff date for this analysis was Aug 9, 2019. Median efficacy follow-up was 24·0 months (IQR 22·7-26·6). The investigator-assessed objective response rate for patients treated with the selected erdafitinib regimen was 40 (40%; 95% CI 30-49) of 101 patients. The safety profile remained similar to that in the primary analysis, with no new safety signals reported with longer follow-up. Grade 3-4 treatment-emergent adverse events of any causality occurred in 72 (71%) of 101 patients. The most common grade 3-4 treatment-emergent adverse events of any cause were stomatitis (in 14 [14%] of 101 patients) and hyponatraemia (in 11 [11%]). There were no treatment-related deaths. INTERPRETATION: With longer follow-up, treatment with the selected regimen of erdafitinib showed consistent activity and a manageable safety profile in patients with locally advanced or metastatic urothelial carcinoma and prespecified FGFR alterations. FUNDING: Janssen Research & Development.