Julia Canestraro, Rebecca F Silverman, David H Abramson, Jasmine H Francis
{"title":"Drug Rechallenge after Immune Checkpoint Inhibitor-Induced Inflammation and Optic Nerve Disorders.","authors":"Julia Canestraro, Rebecca F Silverman, David H Abramson, Jasmine H Francis","doi":"10.1159/000550281","DOIUrl":"10.1159/000550281","url":null,"abstract":"<p><strong>Introduction: </strong>The aims of the study were to investigate clinical characteristics and spectrum of immune checkpoint inhibitor optic nerve disorders (ICI-OND), including ICI-optic neuritis (ICI-ON), ICI-optic disc edema (ICI-OE), ICI-optic perineuritis, and ICI-panuveitis; to understand the breadth of management options; to investigate long-term outcomes of these patients; and, importantly, to tackle the question of outcomes following rechallenge of these potentially life-preserving drug regimens.</p><p><strong>Methods: </strong>Retrospective analysis, single-center tertiary cancer hospital. Thirty-seven eyes in twenty consecutive patients with ICI-OND treated at Memorial Sloan Kettering Cancer Center between June 16, 2019, and June 5, 2025, were included.</p><p><strong>Results: </strong>In 37 eyes with ICI-OND, the majority of patients had painless loss of vision (85%), bilateral involvement (70%), dyschromatopsia (59%), abnormal testing: visual field (79%), retinal nerve fiber layer optical coherence tomography (80%), and magnetic resonance imaging (56%). Time to diagnosis occurred following a median of 4.5 drug cycles and was shorter with combination ICI (two ICI's) versus monotherapy (one ICI). The 3 patients with pain all had concurrent intraocular inflammation. Following steroid treatment and ICI cessation, vision was improved in 84% of eyes, stable in 11%, and declined in 5%. Snellen lines regained was associated with baseline vision (<i>p</i> = 0.0002). Five patients were rechallenged, and we did not see nor detect recurrence of ICI-OND in 4 patients; 1 patient had recurrence which resolved with steroids and vision returned to baseline.</p><p><strong>Conclusions: </strong>In the majority of cases, ICI-OND occurs bilaterally with painless vision decline and color vision deficits. Cessation of drug along with initiation of systemic steroids can improve vision to 20/40 or better in at least one involved eye, and although we included a smaller subset of patients, we found that ICI can be rechallenged after completion of steroids, without documented recurrence of ICI-OND in most patients.</p>","PeriodicalId":19434,"journal":{"name":"Ocular Oncology and Pathology","volume":" ","pages":"69-80"},"PeriodicalIF":1.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12893765/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146181272","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Carolina Gentile, Maria Valentina Ranno, Stephany Loraine Lucia Salcedo Camargo, Lucila Tajtelbaum, Juan Ignacio Simunovich Garnero, Charbel Viñolo Chaca, Paola De la Iglesia Niveyro
{"title":"Extraocular Extension in Melanoma at an Ocular Oncology Unit in Buenos Aires.","authors":"Carolina Gentile, Maria Valentina Ranno, Stephany Loraine Lucia Salcedo Camargo, Lucila Tajtelbaum, Juan Ignacio Simunovich Garnero, Charbel Viñolo Chaca, Paola De la Iglesia Niveyro","doi":"10.1159/000551168","DOIUrl":"10.1159/000551168","url":null,"abstract":"<p><strong>Introduction: </strong>Extrascleral extension (EOE) of uveal melanoma is a known negative prognostic factor, more frequently observed in medium to large tumors. Although EOE is typically limited in size, extensive cases present significant challenges in treatment planning, and the optimal management approach remains controversial. This study aimed to estimate the incidence of EOE in patients with uveal melanoma and analyze the prognosis of patients treated at the Italian Hospital of Buenos Aires from 2007 to June 2024.</p><p><strong>Methods: </strong>We conducted an observational, analytical, retrospective cohort study from 2007 to June 2024. Patients with EOE at diagnosis or during follow-up were identified. Epidemiological characteristics, tumor dimensions, timing of EOE, metastasis occurrence, and survival data were analyzed.</p><p><strong>Results: </strong>A total of 181 patients diagnosed with uveal melanoma were included, of whom twelve (6.62%) presented EOE, and 54.5% were male. The mean age was 64.41 years (SD 14.39). Six patients (50%) had EOE at diagnosis (average tumor thickness 9.51 mm, average diameter 17.7 mm), while six developed it during follow-up. The median time to event was 31.5 months (range: 8-120 months). Among these 12 patients, three developed metastases within the first year after diagnosis and treatment.</p><p><strong>Conclusions: </strong>EOE is a poor prognostic factor and tends to occur in larger tumors. It may be present at diagnosis or appear years later, reinforcing the need for long-term surveillance. Early identification is crucial to ensure appropriate treatment.</p>","PeriodicalId":19434,"journal":{"name":"Ocular Oncology and Pathology","volume":" ","pages":"128-136"},"PeriodicalIF":1.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13108970/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147777495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Uveal Melanoma: Changing Paradigms of Treatment.","authors":"Sophie Piperno-Neumann","doi":"10.1159/000549994","DOIUrl":"10.1159/000549994","url":null,"abstract":"<p><strong>Background: </strong>Despite effective management of the primary tumor, up to 50% of patients with uveal melanoma develop metastases, with poor outcomes.</p><p><strong>Summary: </strong>In 2022, tebentafusp became the first approved systemic therapy to improve overall survival in metastatic UM. Tebentafusp is an immune-modulating bispecific fusion protein restricted to HLA A02:01, using a T-cell receptor targeting glycoprotein 100, a melanocyte lineage-specific antigen expressed on UM cells, capable of recruiting and activating polyclonal CD3 T cells. Reduction in circulating tumor DNA is associated with improved survival across all response categories and may serve as a surrogate biomarker to guide treatment decisions. Tebentafusp's mechanism of action and safety profile support combination trials with regional or systemic therapies and its evaluation in the ATOM adjuvant study for high-risk UM patients. As half of the patients are HLA A02:01 negative, alternative strategies are under investigation, including the protein kinase C inhibitor darovasertib in the NADOM neoadjuvant/adjuvant trial and in combination with crizotinib in metastatic UM. DYP688, a first-in-class PMEL17-targeting antibody-drug conjugate that inhibits GNAQ/11 signaling, has shown promise in metastatic UM and other GNAQ/11-mutant melanomas.</p><p><strong>Key message: </strong>The landscape of UM treatment is rapidly evolving following the identification of new targets and pathways such as PKC or PRAME. Combination of liver-directed therapies with personalized systemic immunotherapies or targeted agents in the metastatic disease, as well as the early use of systemic therapies in the primary tumor setting will refine treatment strategies in UM and suggest improved outcomes in the near future.</p>","PeriodicalId":19434,"journal":{"name":"Ocular Oncology and Pathology","volume":" ","pages":"107-116"},"PeriodicalIF":1.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12962742/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147377306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Multimodal Imaging Features of Bilateral Diffuse Uveal Melanocytic Proliferation: A Systematic Review of 82 Patients.","authors":"Almila Sarıgül Sezenöz, Aslan Aykut, Buse Güneri Beşer, Sarinee Juntipwong, Bernadete Ayres, Hakan Demirci","doi":"10.1159/000550536","DOIUrl":"10.1159/000550536","url":null,"abstract":"<p><strong>Introduction: </strong>Bilateral diffuse uveal melanocytic proliferation (BDUMP) is a rare paraneoplastic syndrome characterized by proliferation of benign melanocytes throughout the uveal tract. Our purpose was to quantify the prevalence of multimodal imaging findings in BDUMP and identify features that most reliably characterize this rare paraneoplastic syndrome.</p><p><strong>Methods: </strong>We conducted a systematic review following PRISMA 2020 guidelines, searching PubMed/MEDLINE, Web of Science, and Embase through September 2025. We included case reports and series providing patient-level data on BDUMP with associated imaging. Prevalence rates were calculated using a documented denominator approach with 95% Wilson score confidence intervals.</p><p><strong>Results: </strong>Sixty-seven studies encompassing 82 patients were included. Median age was 67 years (range 35-88); 54.9% were female. Gynecologic (25.9%), gastrointestinal (22.2%), and lung (17.3%) cancers were most common. Optical coherence tomography revealed retinal pigment epithelium irregularities in 91.8% and subretinal fluid in 90.2% of patients, exceeding the prevalence of classical orange-red patches on fundus photography (82.6%). Fundus autofluorescence showed alternating hypo/hyperautofluorescence in 76.6%. Choroidal thickening was present in 88.9% on ultrasonography. Bacillary layer detachment was identified in 16.4% of cases.</p><p><strong>Conclusion: </strong>OCT-based structural abnormalities are more consistently present than Gass's classical funduscopic signs. These quantitative data may assist earlier recognition of BDUMP and suggest that updated diagnostic criteria should incorporate multimodal imaging findings.</p>","PeriodicalId":19434,"journal":{"name":"Ocular Oncology and Pathology","volume":" ","pages":"117-127"},"PeriodicalIF":1.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12987679/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147463714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Intractable Elevated Intraocular Pressure during Plaque Brachytherapy for Posterior Choroidal Tumors: A Case Report.","authors":"Mohamed Belmouhand, Jens Folke Kiilgaard, Carsten Faber","doi":"10.1159/000550817","DOIUrl":"10.1159/000550817","url":null,"abstract":"<p><strong>Introduction: </strong>Uncontrolled elevated intraocular pressure (IOP) during brachytherapy for posterior choroidal tumors is unreported. We present 2 patients who both experienced intractable elevated IOP during plaque brachytherapy.</p><p><strong>Case presentation: </strong>Both patients experienced persistent elevated IOP unresponsive to all pressure-lowering agents following surgery that included transvitreal retinochoroidal biopsy and ruthenium-106 plaque application for posterior choroidal tumors in the superior quadrants. During plaque placement in patient 1, a large, dilated vortex vein was observed in the area where the plaque was to be placed. After plaque removal in both patients, IOP normalized without the need for additional pressure-lowering therapy.</p><p><strong>Conclusion: </strong>We hypothesize that the clinical presentation in both patients was primarily attributable to two factors: first, pre-existing venous congestion and, second, the application of a plaque, which obstructed a superior vortex vein. This left the remaining vortex veins unable to compensate for the obstruction, leading to intractable IOP during plaque brachytherapy.</p>","PeriodicalId":19434,"journal":{"name":"Ocular Oncology and Pathology","volume":" ","pages":"103-106"},"PeriodicalIF":1.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13008412/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147513648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Novel Clinical Observations after Photodynamic Therapy in Choroidal Osteoma: A Three-Case Series.","authors":"Javier Elizalde, Santiago Abengoechea, Anna Bruix","doi":"10.1159/000550572","DOIUrl":"10.1159/000550572","url":null,"abstract":"<p><strong>Introduction: </strong>Choroidal osteoma is a benign intraocular tumor that often presents in the juxtapapillary or macular region of young adult females. Factors contributing to severe vision impairment include tumor growth to the fovea, isolated subretinal fluid (SRF), alterations of the retinal pigment epithelium, macular edema, or serosanguineous SRF related to the development of choroidal neovascularization. This paper evaluates the effectiveness of photodynamic therapy (PDT) in treating symptomatic SRF and preventing foveal involvement, providing valuable long-term data and highlighting some previously unreported minor complications related to the treatment.</p><p><strong>Case presentations: </strong>In case 1, a 23-year-old woman with a juxtapapillary choroidal osteoma and symptomatic SRF was treated with PDT. Two months later, the visual acuity improved from 20/50 to 20/20 with complete resolution of the fluid. In case 2, an asymptomatic 22-year-old woman with a juxtapapillary choroidal osteoma was treated with a single PDT session, and progressive tumor decalcification was observed. Visual field testing after the treatment revealed the development of two small deep scotomas inferior to the physiological blind spot, which were not perceived by the patient, while visual acuity has remained at 20/20 15 years after the treatment. In case 3, a 38-year-old woman with a paracentral scotoma related to a juxtafoveal choroidal osteoma was treated with a single PDT session to prevent potential complications. Twenty days after the treatment, a subretinal hemorrhage was observed between the posterior margin of the tumor and the fovea, and 2 months later it spontaneously disappeared. Tumor decalcification was noticed 4 months after the treatment, the visual acuity dropped to 20/30, and the paracentral scotoma increased. Since then, the functional parameters have remained stable.</p><p><strong>Conclusion: </strong>This study reinforces the established role of PDT in the management of choroidal osteoma, resolving SRF, promoting tumor decalcification and preventing central tumor extension after long-term follow-up. However, it also highlights the occurrence of a self-limited subretinal hemorrhage following the application of PDT and the development of permanent paracentral scotomas as a treatment-related effect.</p>","PeriodicalId":19434,"journal":{"name":"Ocular Oncology and Pathology","volume":" ","pages":"87-93"},"PeriodicalIF":1.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12959922/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147366075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Saloni Kapoor, Asad Javed, Nasreen A Syed, Erin M Shriver, Julius I Yevdash, Colin Kenny, Jennifer Menke, H Culver Boldt, Elaine Binkley
{"title":"Rectus Muscle Metastasis from Primary Uveal Melanoma: A Case Series and Literature Review.","authors":"Saloni Kapoor, Asad Javed, Nasreen A Syed, Erin M Shriver, Julius I Yevdash, Colin Kenny, Jennifer Menke, H Culver Boldt, Elaine Binkley","doi":"10.1159/000550593","DOIUrl":"10.1159/000550593","url":null,"abstract":"<p><strong>Introduction: </strong>We aim to describe 2 patients with metastatic uveal melanoma who developed metastases to the contralateral rectus muscles and review the literature on this rare presentation.</p><p><strong>Case presentations: </strong>Patient 1 was a woman in her 60s with a history of cirrhosis who presented with a medium-sized choroidal melanoma in the right eye that was treated with plaque brachytherapy. She underwent regular hepatic imaging for surveillance post-treatment. Two-and-a-half years later, she developed diplopia, and a left medial rectus muscle lesion was found on MRI imaging. Biopsy was consistent with metastatic uveal melanoma. Systemic therapy with tebentafusp was initiated. The lesion slowly progressed over 2 years. The patient passed away from complications from her cirrhosis. Patient 2 was a man in his 70s with a large choroidal melanoma in the left eye treated with enucleation. He had metastatic disease at the time of diagnosis that was treated with multiple systemic therapies. Metastases to the right superior and lateral rectus muscles were noted on MRI imaging and were initially observed. He developed painful proptosis and was found to have acute enlargement of the lesions. Treatment with 30 Gy external beam radiation to the right orbit was performed with good local response. He passed away from tumor progression.</p><p><strong>Conclusion: </strong>Metastasis to rectus muscles from uveal melanoma has historically been exceedingly rare. These cases highlight new challenges in treating symptomatic intraorbital metastasis as surgical outcomes and survival improve in patients due to advances in systemic therapy.</p>","PeriodicalId":19434,"journal":{"name":"Ocular Oncology and Pathology","volume":" ","pages":"94-102"},"PeriodicalIF":1.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12975273/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147434460","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lena Zimmermann, Luise Grajewski, Christiane Kneifel, Ilja F Ciernik, Lothar Krause
{"title":"Five-Year Treatment Outcomes with 0.19 µg Fluocinolone Acetonide in Radiation-Induced Maculopathy.","authors":"Lena Zimmermann, Luise Grajewski, Christiane Kneifel, Ilja F Ciernik, Lothar Krause","doi":"10.1159/000552282","DOIUrl":"10.1159/000552282","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic macular edema is a well-recognized complication of radiation-induced maculopathy (RM). Current treatment methods vary in efficacy and clinical benefit. The potential of fluocinolone acetonide (FAc) slow-release intravitreal implants (Iluvien® implant) remains unclear. We hypothesized that local continuous delivery of low-dose corticosteroids may improve RM symptoms.</p><p><strong>Methods: </strong>This study included 8 patients who presented with RM after <sup>106</sup>-Ru-plaque brachytherapy (<i>n</i> = 3), proton beam therapy (<i>n</i> = 2), or stereotactic radiation therapy (<i>n</i> = 3) with photons. All eyes were initially treated with triamcinolone injections but proved refractory to steroids. The Iluvien® implant was injected, and patients were followed to monitor clinical improvement.</p><p><strong>Results: </strong>After 5 years, visual acuity improved in 3 patients, remained stable in 2 patients, and decreased in 2 patients. One patient progressed to no light perception following treatment. One patient was lost to follow-up after 5 years. Central macular thickness was reduced in 5 patients, stable in 1 patient, and increased in 1 patient.</p><p><strong>Discussion: </strong>Slow-release FAc implants are a promising treatment option to improve the anatomical structure of the fovea and visual function. They may also reduce the frequency of intravitreal injections and the overall therapeutic burden.</p>","PeriodicalId":19434,"journal":{"name":"Ocular Oncology and Pathology","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13363278/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148437128","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Connor J Alder, Ashley Ahlbrand, Carolyn K McCourt, Erin G Sieck
{"title":"Rapidly Progressing Bilateral Cataracts during Mirvetuximab Soravtansine Therapy: A Case Series.","authors":"Connor J Alder, Ashley Ahlbrand, Carolyn K McCourt, Erin G Sieck","doi":"10.1159/000552640","DOIUrl":"10.1159/000552640","url":null,"abstract":"<p><strong>Introduction: </strong>Mirvetuximab soravtansine is an antibody-drug conjugate approved for the treatment of folate receptor alpha-expressing ovarian cancer and is associated with ocular adverse events. Patients treated with mirvetuximab soravtansine often develop moderate to severe keratopathy, requiring topical steroids. Recent studies suggest a higher incidence of cataract formation than initially reported. This case series describes the rapid development of visually significant cataracts in 3 patients receiving mirvetuximab therapy.</p><p><strong>Case presentations: </strong>Three female patients undergoing treatment with mirvetuximab soravtansine for platinum-resistant serous ovarian cancer experienced significant visual decline after 11, 18, and 19 treatment cycles, in 1 case progressing from 20/25 to counting fingers in both eyes within 10 weeks. All patients had baseline ophthalmic examinations and were treated with prophylactic topical corticosteroids to mitigate corneal complications. Despite standard management, each patient developed bilateral posterior subcapsular cataracts with substantial loss of visual acuity. Patients underwent sequential or same-day bilateral cataract extraction without complication. Postoperatively, all patients regained their baseline vision, and oncologic therapy was continued.</p><p><strong>Conclusion: </strong>Rapidly progressing posterior subcapsular cataracts may occur in patients receiving prolonged mirvetuximab soravtansine therapy and may reflect drug-related toxicity, steroid exposure, or a synergistic interaction. Given that these patients did not develop cataracts until later cycles, ophthalmologic monitoring may be warranted beyond the duration specified in current treatment protocols. Early recognition and cataract surgery can restore vision without requiring cessation of oncologic therapy.</p>","PeriodicalId":19434,"journal":{"name":"Ocular Oncology and Pathology","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13387748/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148549956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Fahad R Butt, Sidrat Rahman, Thanansayan Dhivagaran, Brendan K Tao, Mahraz Parvand, David Gou, Edsel B Ing
{"title":"Non-Publication of Interventional Studies for Uveal Melanoma.","authors":"Fahad R Butt, Sidrat Rahman, Thanansayan Dhivagaran, Brendan K Tao, Mahraz Parvand, David Gou, Edsel B Ing","doi":"10.1159/000552642","DOIUrl":"10.1159/000552642","url":null,"abstract":"<p><strong>Introduction: </strong>Evidence-based medicine relies on publicly available research findings, and the non-publication of studies may predispose to incomplete evidence on intervention efficacy or redundant funding for re-attempting unpublished studies. This study investigated non-publication rates among US-registered interventional studies for uveal melanoma.</p><p><strong>Methods: </strong>In April 2025, ClinicalTrials.gov was searched for interventional uveal melanoma studies. Interventional studies were included if completed at least 3 years prior to the database search, excluding completed trials awaiting results publication. Studies were labeled as having publicly available results if data were posted through ClinicalTrials.gov or in a journal publication. For published studies, we determined whether their primary study endpoint result was statistically significant. For all records, we collected study characteristics, including phase, sponsor, country of study, year of study initiation, enrollment, melanoma type, treatment type, and randomization status. The primary outcome was the overall rate of non-publication among all records. Second, we provided descriptive characteristics of included records and compared rates of non-publication between sublevels of primary endpoint significance status and study characteristics. Wherever applicable, the Fisher-exact, Wilcox rank-sum, and binomial exact tests analyzed these comparisons. Analysis was completed in RStudio (v2022.02 + 433).</p><p><strong>Results: </strong>From 102 records, we identified 98 trials (<i>N</i> = 4,669) for final inclusion. Overall, 38% of records did not have an identifiable online publication on any platform. Whether published or unpublished, 23% and 16% of trials were terminated, respectively, and the reasons for termination were heterogeneous. Trials with industry sponsorship were significantly more often published than those without industry sponsorship (<i>p</i> = 0.024). No significant association was found between publication status and study phase, enrollment size, study duration, or randomization status. Among the 60 studies published online, 64% had reported significant primary study endpoints. Given this, the calculated probability of publication to ClinicalTrials.gov or in a journal was 65% [95% CI: 51.60-76.87%; <i>p</i> = 0.03]. No significant association was found between significant positive primary outcome results and randomization status or sponsor type.</p><p><strong>Conclusion: </strong>About one-third of US-registered uveal melanoma interventional studies were not published online. Greater transparency of results or reasons for non-publication is needed.</p>","PeriodicalId":19434,"journal":{"name":"Ocular Oncology and Pathology","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13363280/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148437103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}