Bertelmann, Thomas

[["dc.bibliographiccitation.firstpage","271"],["dc.bibliographiccitation.issue","1"],["dc.bibliographiccitation.journal","Case reports in ophthalmology"],["dc.bibliographiccitation.lastpage","278"],["dc.bibliographiccitation.volume","8"],["dc.contributor.author","Bertelmann, Thomas"],["dc.contributor.author","Frank, Hans Ulrich"],["dc.contributor.author","Fuchs, Hendrik Ansgar"],["dc.contributor.author","Feltgen, Nicolas"],["dc.date.accessioned","2020-12-10T18:37:48Z"],["dc.date.available","2020-12-10T18:37:48Z"],["dc.date.issued","2017"],["dc.identifier.doi","10.1159/000475520"],["dc.identifier.eissn","1663-2699"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/77096"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-354"],["dc.title","Branch Retinal Vein Occlusion, Macular Ischemia, and Intravitreal Anti-VEGF Therapy"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.artnumber","7"],["dc.bibliographiccitation.issue","1"],["dc.bibliographiccitation.journal","BMC Ophthalmology"],["dc.bibliographiccitation.volume","17"],["dc.contributor.author","Ziemssen, F."],["dc.contributor.author","Feltgen, N."],["dc.contributor.author","Holz, FG."],["dc.contributor.author","Guthoff, R."],["dc.contributor.author","Ringwald, A."],["dc.contributor.author","Bertelmann, T."],["dc.contributor.author","Wiedon, A."],["dc.contributor.author","Korb, C."],["dc.date.accessioned","2019-07-09T11:43:05Z"],["dc.date.available","2019-07-09T11:43:05Z"],["dc.date.issued","2017"],["dc.description.abstract","Abstract Background While randomized controlled trials (RCTs) are based on strict inclusion/exclusion criteria, non-interventional studies (NISs) might provide additional information to guide management in patients more representative to the real-world setting. The aim of this study was to compare baseline characteristics of patients receiving intravitreal treatment in the NIS OCEAN with those from published RCTs. Methods The ongoing OCEAN study enrolled patients treated with ranibizumab for neovascular age-related macular degeneration (nAMD), diabetic macular oedema (DME) or branch/central retinal vein occlusion (B/CRVO). Baseline patient characteristics were compared by indication within the OCEAN cohort. Furthermore, the characteristics were set in reference to those of published RCTs in the same indications. Confidence intervals (CIs) were calculated and assessed for statistically significant differences as indicated by non-overlapping CIs. Results Patient characteristics in the NIS OCEAN were evaluated for 3,614 patients with nAMD, 1,211 with DME, 204 with BRVO and 121 with CRVO. Between these groups, significant differences in mean age, gender distributions, and mean baseline VA were seen, reflecting known differences between the indications. Compared to the patient characteristics of published RCTs (trials selected by literature search: nAMD: 13 RCTs, DME: 9, RVO: 5), the OCEAN patients’ mean age was significantly higher in every indication. The gender distributions across the trials were comparable, with only few differences between OCEAN and the RCTs. Regarding the mean baseline VA, notable differences were found in nAMD and in DME, with VA significantly higher in some RCTs and lower in others. Conclusions The described differences underline the complementarity of NISs and RCTs. OCEAN covers a broader spectrum and more variability of patients than do RCTs. As baseline values may have impact on the treatment response (ceiling effect), there is an ongoing need for research in all patient subgroups. Country-specific assessments of patient populations can better reflect the real-world situation. NISs can deliver insights that RCTs may not, as NISs can include non-typical patients, patients with comorbidities, a broader age spectrum and patients of various disease stages. Trial registration The NIS OCEAN was registered on www.clinicaltrials.gov (identifier: NCT02194803 )."],["dc.identifier.doi","10.1186/s12886-017-0401-y"],["dc.identifier.pmid","28103831"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/14161"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/58822"],["dc.language.iso","en"],["dc.notes.intern","Merged from goescholar"],["dc.publisher","BioMed Central"],["dc.rights","CC BY 4.0"],["dc.rights.uri","https://creativecommons.org/licenses/by/4.0"],["dc.title","Demographics of patients receiving Intravitreal anti-VEGF treatment in real-world practice: healthcare research data versus randomized controlled trials"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","604"],["dc.bibliographiccitation.issue","5"],["dc.bibliographiccitation.journal","Current Eye Research"],["dc.bibliographiccitation.lastpage","614"],["dc.bibliographiccitation.volume","45"],["dc.contributor.author","Pielen, Amelie"],["dc.contributor.author","Feltgen, Nicolas"],["dc.contributor.author","Hattenbach, Lars-Olof"],["dc.contributor.author","Hoerauf, Hans"],["dc.contributor.author","Bertelmann, Thomas"],["dc.contributor.author","Quiering, Claudia"],["dc.contributor.author","Vögeler, Jessica"],["dc.contributor.author","Priglinger, Siegfried"],["dc.contributor.author","Lang, Gabriele E."],["dc.contributor.author","Schmitz-Valckenberg, Steffen"],["dc.contributor.author","Wolf, Armin"],["dc.contributor.author","Rehak, Matus"],["dc.date.accessioned","2021-04-14T08:26:42Z"],["dc.date.available","2021-04-14T08:26:42Z"],["dc.date.issued","2019"],["dc.identifier.doi","10.1080/02713683.2019.1679839"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/82046"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-399"],["dc.relation.eissn","1460-2202"],["dc.relation.issn","0271-3683"],["dc.title","Ranibizumab Pro Re nata versus Dexamethasone in the Management of Ischemic Retinal Vein Occlusion: Post-hoc Analysis from the COMRADE Trials"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","e933"],["dc.bibliographiccitation.issue","8"],["dc.bibliographiccitation.journal","Acta Ophthalmologica"],["dc.bibliographiccitation.lastpage","e941"],["dc.bibliographiccitation.volume","96"],["dc.contributor.author","Feltgen, Nicolas"],["dc.contributor.author","Hattenbach, Lars-Olof"],["dc.contributor.author","Bertelmann, Thomas"],["dc.contributor.author","Callizo, Josep"],["dc.contributor.author","Rehak, Matus"],["dc.contributor.author","Wolf, Armin"],["dc.contributor.author","Berk, Hüsnü"],["dc.contributor.author","Eter, Nicole"],["dc.contributor.author","Lang, Gabriele E."],["dc.contributor.author","Pielen, Amelie"],["dc.contributor.author","Schmitz-Valckenberg, Steffen"],["dc.contributor.author","Quiering, Claudia"],["dc.contributor.author","Rose, Uwe"],["dc.contributor.author","Hoerauf, Hans"],["dc.date.accessioned","2020-12-10T18:26:52Z"],["dc.date.available","2020-12-10T18:26:52Z"],["dc.date.issued","2018"],["dc.identifier.doi","10.1111/aos.13770"],["dc.identifier.issn","1755-375X"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/76197"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-354"],["dc.title","Comparison of ranibizumab versus dexamethasone for macular oedema following retinal vein occlusion: 1-year results of the COMRADE extension study"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.artnumber","132"],["dc.bibliographiccitation.journal","Health and Quality of Life Outcomes"],["dc.bibliographiccitation.volume","14"],["dc.contributor.author","Bertelmann, Thomas"],["dc.contributor.author","Feltgen, Nicolas"],["dc.contributor.author","Scheffler, Martin"],["dc.contributor.author","Hufenbach, Ulrich"],["dc.contributor.author","Wiedon, Annette"],["dc.contributor.author","Wilhelm, Helmut"],["dc.contributor.author","Ziemssen, Focke"],["dc.date.accessioned","2018-11-07T10:08:27Z"],["dc.date.available","2018-11-07T10:08:27Z"],["dc.date.issued","2016"],["dc.description.abstract","Background: Vision-related quality of life (vrQoL) is advancing more and more into the focus of interest in ophthalmological clinical research. However, to date only little information is available about vrQoL from large non-interventional studies in terms of \"real-world evidence\". The purpose of this investigation was to describe baseline VFQ-25 visual function scores, to evaluate whether they differ from previous phase III clinical trials, to determine which contributing factors (e.g. indication, age, gender) affect VFQ-25 scores and to identify its impact on driving. Methods: The non-interventional OCEAN study (Observation of treatment patterns with LuCEntis and real life ophthalmic monitoring, including optional OCT in Approved iNdications) is the largest ophthalmic study conducted in Germany, to evaluate the real world situation of patients treated with ranibizumab (NCT02194803). The NEI-VFQ-25 questionnaire was conducted at baseline, months 4, 12 and 24. Descriptive statistics was used to analyse the baseline data. ANOVA was performed to evaluate the impact of various contributing factors on composite and selected subscale scores. Results: Overall, 4844 (84.1 %) of all 5760 OCEAN patients completed the VFQ-25 questionnaire at baseline. Thereof, 3414 treatment-naive patients were further analysed. Overall, the VFQ subscore general health was most affected by the ocular disease, followed by general vision. No major differences were detected in comparison to corresponding VFQ-25 scores of previous phase III clinical trials, except in DME patients, or with respect to possible contributing factors. A tendency towards a more decreased VFQ-25 composite score was observed for nAMD, for elderly patients >= 75 years of age, for female patients, for patients with low baseline visual acuity (VA; <50 letters) and for those with statutory health insurance. Indication, age, gender, baseline VA (all p <0.01) and the interaction of age and indication, as well as baseline VA and indication (p <0.01 each) had a significant impact on composite, general vision and distance vision scores (ANOVA). About 10 % of patients gave up driving due to eyesight issues. Conclusions: The knowledge of a patient's subjective disease burden is crucial to understanding anxieties and mental anguish. Additionally, the understanding of the impact of various contributing factors on the VFQ-25 scores and the extent to which they can be influenced help to optimize patient care. It demonstrates the need for medical and mental support by all medical staff, to encourage patients' compliance with a comprehensive anti-VEGF therapy, to increase BCVA and, consecutively, VFQ-25 scores."],["dc.description.sponsorship","Novartis Pharma GmbH, Germany"],["dc.identifier.doi","10.1186/s12955-016-0536-1"],["dc.identifier.isi","000384693800001"],["dc.identifier.pmid","27644469"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/13885"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/39464"],["dc.notes.intern","Merged from goescholar"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.publisher","Biomed Central Ltd"],["dc.relation.issn","1477-7525"],["dc.rights","CC BY 4.0"],["dc.rights.uri","https://creativecommons.org/licenses/by/4.0"],["dc.title","Vision-related quality of life in patients receiving intravitreal ranibizumab injections in routine clinical practice: baseline data from the German OCEAN study"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.status","published"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","1092"],["dc.bibliographiccitation.issue","8"],["dc.bibliographiccitation.journal","British Journal of Ophthalmology"],["dc.bibliographiccitation.lastpage","1097"],["dc.bibliographiccitation.volume","102"],["dc.contributor.author","Paul, Christoph"],["dc.contributor.author","Heun, Christine"],["dc.contributor.author","Müller, Hans-Helge"],["dc.contributor.author","Hoerauf, Hans"],["dc.contributor.author","Feltgen, Nicolas"],["dc.contributor.author","Wachtlin, Joachim"],["dc.contributor.author","Kaymak, Hakan"],["dc.contributor.author","Mennel, Stefan"],["dc.contributor.author","Koss, Michael Janusz"],["dc.contributor.author","Fauser, Sascha"],["dc.contributor.author","Maier, Mathias M"],["dc.contributor.author","Schumann, Ricarda G"],["dc.contributor.author","Mueller, Simone"],["dc.contributor.author","Chang, Petrus"],["dc.contributor.author","Schmitz-Valckenberg, Steffen"],["dc.contributor.author","Kazerounian, Sara"],["dc.contributor.author","Szurman, Peter"],["dc.contributor.author","Lommatzsch, Albrecht"],["dc.contributor.author","Bertelmann, Thomas"],["dc.date.accessioned","2020-12-10T18:37:12Z"],["dc.date.available","2020-12-10T18:37:12Z"],["dc.date.issued","2018"],["dc.identifier.doi","10.1136/bjophthalmol-2017-310874"],["dc.identifier.eissn","1468-2079"],["dc.identifier.issn","0007-1161"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/76873"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-354"],["dc.title","Calculating the individual probability of successful ocriplasmin treatment in eyes with VMT syndrome: a multivariable prediction model from the EXPORT study"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","2167"],["dc.bibliographiccitation.journal","Clinical Ophthalmology"],["dc.bibliographiccitation.lastpage","2179"],["dc.bibliographiccitation.volume","Volume 13"],["dc.contributor.author","Callizo, Josep"],["dc.contributor.author","Ziemssen, Focke"],["dc.contributor.author","Bertelmann, Thomas"],["dc.contributor.author","Feltgen, Nicolas"],["dc.contributor.author","Voegeler, Jessica"],["dc.contributor.author","Koch, Mirja"],["dc.contributor.author","Eter, Nicole"],["dc.contributor.author","Liakopoulos, Sandra"],["dc.contributor.author","Schmitz-Valckenberg, Steffen"],["dc.contributor.author","Spital, Georg"],["dc.date.accessioned","2020-12-10T18:43:01Z"],["dc.date.available","2020-12-10T18:43:01Z"],["dc.date.issued","2019"],["dc.identifier.doi","10.2147/OPTH.S209253"],["dc.identifier.eissn","1177-5483"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/78165"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-354"],["dc.relation.eissn","1177-5483"],["dc.title","Real-World Data: Ranibizumab Treatment For Retinal Vein Occlusion In The OCEAN Study"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.artnumber","24096"],["dc.bibliographiccitation.issue","1"],["dc.bibliographiccitation.journal","Scientific Reports"],["dc.bibliographiccitation.volume","11"],["dc.contributor.author","Bertelmann, Thomas"],["dc.contributor.author","Berndzen, Lars"],["dc.contributor.author","Raber, Thomas"],["dc.contributor.author","Pfeiffer, Sebastian"],["dc.contributor.author","Leha, Andreas"],["dc.contributor.author","Paul, Christoph"],["dc.contributor.author","Feltgen, Nicolas"],["dc.contributor.author","Bemme, Sebastian"],["dc.date.accessioned","2022-01-11T14:08:03Z"],["dc.date.available","2022-01-11T14:08:03Z"],["dc.date.issued","2021"],["dc.description.abstract","The primary objective was to create and establish a new formula that predicts the individual probability of macular hole closure for eyes with full thickness macular holes (FTMH) accompanied by vitreomacular traction (VMT) which received enzymatic vitreolysis using intravitreally administered ocriplasmin. The secondary objective was to evaluate the forecast reliability of a previously published formula for VMT resolution in VMT-only eyes (Odds IVO-Success  = e Intercept  × OR years  × OR ln(µm) ; Probability IVO-Success  = Odds IVO-Success /(Odds IVO-Success  + 1)) on VMT resolution using the current dataset of eyes with FTMH accompanied by VMT. Retrospective analysis of the OASIS, ORBIT, and INJECT-studies. Patients with FTMH and VMT with complete information (n = 213) were included. The effect of gender, age, FTMH diameter, lens status and the presence of epiretinal membranes (ERM) on FTMH closure was assessed using separate univariate logistic regression analyses. With regard to VMT release separate univariate regression analyses were carried out and results were compared with formerly published data of VMT resolution in eyes with VMT only. Overall, 126 eyes (63%) experienced VMT resolution within 28 days. Younger age (p < 0.0001) and VMT diameter (p = 0.041) had a significant impact on VMT release. Overall, 81 eyes (38%) treated with ocriplasmin showed FTMH closure within 28 days. Univariate analysis of the different predictors analyzed revealed that FTMH diameter < 250 µm had a significant impact on treatment success (p = 0.0495). It was not possible to calculate and establish a new multivariate formula that can predict the individual FTMH closure probability for eyes with FTMHs and VMT. However, the results of VMT release prediction in eyes with FTMHs accompanied by VMT matched the prediction of VMT release in eyes with VMT only when using the previously published formula. All in all, predictors for calculating the individual probability of VMT resolution on the one hand and FTMH closure on the other hand are different suggesting diverse pathophysiological mechanisms."],["dc.description.sponsorship","Open-Access-Publikationsfonds 2022"],["dc.identifier.doi","10.1038/s41598-021-03509-z"],["dc.identifier.pii","3509"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/97924"],["dc.language.iso","en"],["dc.notes.intern","DOI-Import GROB-507"],["dc.relation.eissn","2045-2322"],["dc.rights","CC BY 4.0"],["dc.title","Predicting the individual probability of macular hole closure following intravitreal ocriplasmin injections for vitreomacular traction release using baseline characteristics"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.subtype","original_ja"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","923"],["dc.bibliographiccitation.issue","5"],["dc.bibliographiccitation.journal","Graefe s Archive for Clinical and Experimental Ophthalmology"],["dc.bibliographiccitation.lastpage","934"],["dc.bibliographiccitation.volume","255"],["dc.contributor.author","Feltgen, Nicolas"],["dc.contributor.author","Bertelmann, Thomas"],["dc.contributor.author","Bretag, Mirko"],["dc.contributor.author","Pfeiffer, Sebastian"],["dc.contributor.author","Hilgers, Reinhard"],["dc.contributor.author","Callizo, Josep"],["dc.contributor.author","Goldammer, Lena"],["dc.contributor.author","Bemme, Sebastian"],["dc.contributor.author","Hoerauf, Hans"],["dc.date.accessioned","2018-11-07T10:24:17Z"],["dc.date.available","2018-11-07T10:24:17Z"],["dc.date.issued","2017"],["dc.description.abstract","Purpose To evaluate prospectively the efficacy and safety of a fixed bimonthly ranibizumab treatment regimen (RABIMO) in eyes with neovascular age-related macular degeneration (nAMD) and to compare these results with a pro re nata (PRN) treatment scheme. Methods This was a 12-month, phase IV, single center, randomised, non-inferiority study. Following three initial monthly injections, patients were randomised to receive either ranibizumab bimonthly (RABIMO group) or ranibizumab PRN (PRN group) (n = 20 each). Main outcome measures were best-corrected visual acuity (BCVA), central retinal thickness (CRT), number of injections, and adverse events (AEs). Results BCVA [median (interquartile range, IQR)] increased significantly in both groups after 12 months [RABIMO group +8.5 (14); PRN group +6.5 (16) ETDRS letters] when compared to baseline (p < 0.0001; p = 0.0085). At month 12, the RABIMO treatment regimen was non-inferior to the PRN scheme (Delta BCVA = 3.5 ETDRS letters; p < 0.0001). CRT was significantly reduced in both groups after the 12-month study period (p < 0.0001 each), with no significant difference between groups (p = 0.6772). Number of overall injections [median (IQR)] was 8 (0) in the RABIMO versus 4 (5) in the PRN group (p = 0.0037). Three patients in the RABIMO group received one additional unscheduled injection. We observed no significant differences between groups in the number of patients with reported SAEs/AEs (RABIMO group n = 6/15; PRN group n = 7/13) (p = 0.7357/p = 0.4902). Conclusions We found no evidence of significant functional or anatomical differences between the RABIMO and PRN treatment regimens. However, the RABIMO group's number of injections was twice as high as the PRN group's (protocol-driven). In light of potential side effects, the fixed bimonthly treatment regimen might not be advisable for routine clinical care, but it might be a worthwhile treatment option if monthly monitoring is not possible. Eudra-CT number: 2009-017324-11."],["dc.description.sponsorship","Novartis Pharma GmbH, Germany"],["dc.identifier.doi","10.1007/s00417-017-3589-x"],["dc.identifier.isi","000401436500008"],["dc.identifier.pmid","28102456"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/42627"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","PUB_WoS_Import"],["dc.publisher","Springer"],["dc.relation.issn","1435-702X"],["dc.relation.issn","0721-832X"],["dc.title","Efficacy and safety of a fixed bimonthly ranibizumab treatment regimen in eyes with neovascular age-related macular degeneration: results from the RABIMO trial"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.status","published"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","913"],["dc.bibliographiccitation.issue","5"],["dc.bibliographiccitation.journal","Graefe's Archive for Clinical and Experimental Ophthalmology"],["dc.bibliographiccitation.lastpage","920"],["dc.bibliographiccitation.volume","257"],["dc.contributor.author","Callizo, Josep"],["dc.contributor.author","Atili, Abed"],["dc.contributor.author","Striebe, Nina Antonia"],["dc.contributor.author","Bemme, Sebastian"],["dc.contributor.author","Feltgen, Nicolas"],["dc.contributor.author","Hoerauf, Hans"],["dc.contributor.author","Bertelmann, Thomas"],["dc.date.accessioned","2020-12-10T14:10:34Z"],["dc.date.available","2020-12-10T14:10:34Z"],["dc.date.issued","2019"],["dc.identifier.doi","10.1007/s00417-018-04223-9"],["dc.identifier.eissn","1435-702X"],["dc.identifier.issn","0721-832X"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/70802"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-354"],["dc.title","Bevacizumab versus bevacizumab and macular grid photocoagulation for macular edema in eyes with non-ischemic branch retinal vein occlusion: results from a prospective randomized study"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]