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Photocoagulation or sham laser in addition to conventional anti-VEGF therapy in macular edema associated with TelCaps due to diabetic macular edema or retinal vein occlusion (TalaDME): a study protocol for a multicentric, French, two-group, non-commercial, active-control, observer-masked, non-inferiority, randomized controlled clinical trial

dc.rights.licenseopenen_US
dc.contributor.authorDUPAS, Benedicte
dc.contributor.authorCASTRO-FARIAS, Daniela
dc.contributor.authorGIRMENS, Jean-Francois
dc.contributor.authorEGINAY, Ali
dc.contributor.authorCOUTURIER, Aude
dc.contributor.authorVILLEROY, Frederic
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorDELYFER, Marie-Noelle
dc.contributor.authorCREUZOT-GARCHER, Catherine
dc.contributor.authorGIOCANTI-AUREGAN, Audrey
dc.contributor.authorBERAL, Laurence
dc.contributor.authorARNDT, Carl
dc.contributor.authorMESNARD, Charles
dc.contributor.authorVICAUT, Eric
dc.contributor.authorCHAUMET-RIFFAUD, Philippe
dc.contributor.authorDURAND-ZALESKI, Isabelle
dc.contributor.authorPAQUES, Michel
dc.date.accessioned2024-08-22T12:20:30Z
dc.date.available2024-08-22T12:20:30Z
dc.date.issued2024-04-22
dc.identifier.issn1745-6215en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/201258
dc.description.abstractEnBackground Macular edema (ME) results from hyperpermeability of retinal vessels, leading to chronic extravasation of plasma components into the retina and hence potentially severe visual acuity loss. Current standard of care consists in using intravitreal injections (IVI), which results in a significant medical and economic burden. During diabetic retinopathy (DR) or retinal vein occlusion (RVO), it has recently been shown that focal vascular anomalies (capillary macro-aneurysms, also termed TelCaps) for telangiectatic capillaries may play a central role in the onset, early recurrence, and/or persistence of ME. Since targeted photocoagulation of TelCaps may improve vision, identification, and photocoagulation of TelCaps, it may represent a way to improve management of ME.Objective The Targeted Laser in (Diabetic) Macular Edema (TalaDME) study aims to evaluate whether ICG-guided targeted laser (IGTL), in association with standard of care by IVI, allows reducing the number of injections during the first year of treatment compared with IVI only, while remaining non-inferior for visual acuity.Methods TalaDME is a French, multicentric, two-arms, randomized, sham laser-controlled, double-masked trial evaluating the effect of photocoagulation of TelCaps combined to IVI in patients with ME associated with TelCaps. Patients with vision loss related to center involved ME secondary to RVO or DR and presenting TelCaps are eligible. Two hundred and seventy eyes of 270 patients are randomized in a 1:1 ratio to standard care, i.e., IVI of anti-VEGF solely (control group) or combined with IGTL therapy (experimental group). Stratification is done on the cause of ME (i.e., RVO versus diabetes). Anti-VEGF IVI are administered to both groups monthly for 3 months (loading dose) and then with a pro re nata regimen with a monthly follow-up for 12 months. The primary endpoint will be the number of IVI and the change in visual acuity from baseline to 12 months. Secondary endpoints will be the changes in central macular thickness, impact on quality of life, cost of treatment, and incremental cost-utility ratio in each groups.Key safety Rare but severe AE linked to the use of IVI and laser, and previously described, are expected. In the sham group, rescue laser photocoagulation may be administered by the unmasked investigator if deemed necessary at month 3.Discussion The best management of ME associated with TelCaps is debated, and there have been no randomized study designed to answer this question. Given the fact that TelCaps may affect 30 to 60% of patients with chronic ME due to DR or RVO, a large number of patients could benefit from a specific management of TelCaps. TalaDME aims to establish the clinical and medico-economic benefits of additional targeted laser. The results of TalaDME may raise new recommendations for managing ME and impact healthcare costs.Trial registration EudraCT: 2018-A00800-55/ NCT03751501. Registration date: Nov. 23, 2018.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enDiabetic retinopathy
dc.subject.enLaser
dc.subject.enMacular edema
dc.subject.enPhotocoagulation
dc.subject.enRetinal vein occlusion
dc.subject.enTelangiectatic capillaries (TelCaps)
dc.title.enPhotocoagulation or sham laser in addition to conventional anti-VEGF therapy in macular edema associated with TelCaps due to diabetic macular edema or retinal vein occlusion (TalaDME): a study protocol for a multicentric, French, two-group, non-commercial, active-control, observer-masked, non-inferiority, randomized controlled clinical trial
dc.title.alternativeTrialsen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1186/s13063-024-07994-1en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed38649937en_US
bordeaux.journalTrialsen_US
bordeaux.page273en_US
bordeaux.volume25en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue1en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamLEHA_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exportfalse
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Trials&rft.date=2024-04-22&rft.volume=25&rft.issue=1&rft.spage=273&rft.epage=273&rft.eissn=1745-6215&rft.issn=1745-6215&rft.au=DUPAS,%20Benedicte&CASTRO-FARIAS,%20Daniela&GIRMENS,%20Jean-Francois&EGINAY,%20Ali&COUTURIER,%20Aude&rft.genre=article


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