ESTUDIO DE FASE III, MULTICÉNTRICO, PROSPECTIVO, ALEATORIZADO, CON DOBLE ENMASCARAMIENTO, CONTROLADO CON UN COMPARADOR ACTIVO Y DE DOS BRAZOS DE TRATAMIENTO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE KSI-301 INTRAVÍTREO EN COMPARACIÓN CON AFLIBERCEPT INTRAVÍTREO EN PARTICIPANTES NAÏVE CON DETERIORO VISUAL POR EDEMA MACULAR SECUNDARIO A OCLUSIÓN VENOSA RETINIANA (OVR).

Dades bàsiques

Protocol:
KS301P103
EURDRACT:
2020-001061-37
NCT:
Centre:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Any inici:
2021
Any de finalització:
2023
ENSAYO CLÍNICO

Documents

  • No hi ha documents

Participants

Grups d'Investigació

Finançadors - Promotors

KODIAK SCIENCES INC.

Resultats de l'Assaig Clínic


"Venous cavernous malformation in the infraorbital canal with unusual presentation".

Solaz-Ruiz, M G; (...); Espana-Gregori, E

Article. 10.1016/j.oftale.2025.01.009. 2025


[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence

Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda

Editorial Material. 10.1016/j.farma.2024.08.009. 2024

  • Open Access.

[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Andrés JLP, Solsona MDE

Article. 10.1016/j.farma.2023.10.004. 2024

  • Open Access.

[Translated article] New challenges in advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2024.05.001. 2024

  • Open Access.

[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.

Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.12.007. 2025


[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.

Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.09.006. 2024

  • Open Access.

A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain

Zozaya, Neboa; (...); Hidalgo-Vega, Alvaro

Article. 10.33393/grhta.2022.2333. 2022

  • Open Access.

A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.

Zozaya, Neboa; (...); Verde, Luis

Article. 10.1017/S0266462322000459. 2022

  • Open Access.

Acute calcareous corneal degeneration in a patient with chronic graft-versus-host disease.

Ruiz, Marta Gema Solaz; (...); Gregori, Enrique Espana

Review. 10.22336/rjo.2024.10. 2024

  • Open Access.

Analysis of chemical contamination by hazardous drugs with BD HD Check(R) system in a tertiary hospital

Valero García S; (...); Poveda Andrés JL

Article. 10.1177/10781552211038518. 2021


Anterior segment optical coherence tomography in post-operative capsular block syndrome.

Placinta-Tat IA, Vila-Arteaga J, Marí-Cotino JF

Article. 10.1016/j.oftal.2021.01.001. 2021


Antireconverin antibodies in ocular chronic graft versus host disease: A new cause of nonparaneoplasic autoimmune retinopathy

Aguilar Gonzalez, Marina; (...); Espana Gregori, Enrique

Article. 10.1177/11206721221123779. 2022


Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).

Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ

Letter. 10.1111/jdv.19432. 2023

  • Open Access.

Association between Tomographic Characteristics of Pterygium and Preoperative Anterior and Posterior Topography Measured by Anterior Segment Optical Coherence Tomography

Aguilar-Gonzalez, Marina; (...); Peris-Martinez, Cristina

Article. 10.3390/life14101245. 2024

  • Open Access.

Baricitinib against severe COVID-19: effectiveness and safety in hospitalised pretreated patients.

Iglesias Gómez R; (...); Poveda Andrés JL

Article. 10.1136/ejhpharm-2021-002741. 2021

  • Open Access.

Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.

Fernandez Rivera C; (...); Hernandez D

Article. 10.1111/ctr.14550. 2022

  • Open Access.

Clinical benefits of a Bayesian model for plasma-derived factor VIII/VWF after one year of pharmacokinetic-guided prophylaxis in severe/moderate hemophilia A patients

Megias-Vericat, JE; (...); Poveda, JL

Article. 10.1016/j.thromres.2021.07.009. 2021


Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano JB; (...); Soto-Ortega I

Article. 10.1016/j.farma.2023.01.003. 2023

  • Open Access.

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada

Article. 10.1016/j.farma.2023.04.002. 2023


COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN

Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.

Meeting Abstract. 2024


Costs of the management of hemophilia A with inhibitors in Spain

Bonanad, S; (...); Gonzalez-Dominguez, A

Article. 10.33393/grhta.2021.2234. 2021

  • Open Access.

COVID Obesity: A One-Year Narrative Review

Ovalle, Diana L. Palacios; (...); Soriano, Jose M.

Review. 10.3390/nu13062060. 2021

  • Open Access.

Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.

Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL

Editorial Material. 10.1016/j.farma.2024.08.001. 2024

  • Open Access.

Challenges in Diabetic Macular Edema Management: An Expert Consensus Report

Udaondo P; (...); Ruiz-Moreno JM

Article. 10.2147/OPTH.S320948. 2021

  • Open Access.

Changes in nutritional status, body composition and associated symptomatology in hospitalized patients undergoing bone marrow transplantation: prospective longitudinal study

Cabanas-Alite, L; (...); Pinana, LL

Article. 10.14306/renhyd.25.2.1098. 2021

  • Open Access.

Design and rationale for a real-world prospective, multicenter registry of myocardial revascularization failure and secondary revascularization: The REVASEC study.

Salinas P; (...); Escaned J

Article. 10.1016/j.carrev.2021.11.015. 2021


Design and Validation of an Expanded Disability Status Scale Model in Multiple Sclerosis.

Barreiro-Gonzalez, Antonio; (...); Casanova, Bonaventura

Article. 10.1159/000519772. 2022


Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.

Abad, Maria Reyes; (...); Gil, Alicia

Article. 10.33393/grhta.2024.3041. 2024

  • Open Access.

Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis

Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther

Article. 10.1002/jvc2.275. 2024

  • Open Access.

Does hyaluronidase injected in periocular area change skin ultrastructure?: Standardized in vitro analysis

Aguilar-González M; (...); Pérez-López M

Article. 10.1111/jocd.15014. 2022


Economic burden of age-related macular degeneration in routine clinical practice: the RAMDEBURS study

Ruiz-Moreno, JM; (...); Udaondo, P

Article. 10.1007/s10792-021-01906-x. 2021

  • Open Access.

Effectiveness of Caplacizumab Nanobody in Acquired Thrombotic Thrombocytopenic Purpura Refractory to Conventional Treatment

Palanques-Pastor T; (...); Poveda Andrés JL

Article. 10.1159/000517813. 2021


Fetal exposure to tofacitinib during the first trimester: A healthy newborn case report

Fernandez-Sanchez, M; (...); Poveda-Andres, JL

Article. 10.1002/bdr2.1942. 2021


Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.

Plaza J; (...); Moret-Tatay I

Article. 10.3390/ijms25073717. 2024

  • Open Access.

Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis

Poveda Andres, Jose Luis

Editorial Material. 2022


Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study

Solana-Altabella, Antonio; (...); Martinez-Cuadron, David

Article. 10.3390/cancers14081921. 2022

  • Open Access.

High incidence of pulmonary thromboembolism in hospitalized SARS-CoV-2 infected patients despite thrombo-prophylaxis.

El-Qutob D; (...); Carrera-Hueso FJ

Article. 10.1016/j.hrtlng.2022.02.003. 2022

  • Open Access.

Hospital pharmacy initiatives for improving the management of patients with congenital coagulopathies

Bruno Montoro-Ronsano, Jose; (...); Alberto Vella, Vincenzo

Article. 10.7399/fh.11729. 2022


Hospitalization budget impact during the COVID-19 pandemic in Spain.

Carrera-Hueso, F. J.; (...); Crespo-Palomo, C.

Article. 10.1186/s13561-021-00340-0. 2021

  • Open Access.

How can artificial intelligence optimize value-based contracting?

Poveda, Jose Luis; (...); Medrano, Ignacio H.

Letter. 10.1186/s40545-022-00475-3. 2022

  • Open Access.

Impact of Different Clinical Baseline Characteristics on Intravitreal Dexamethasone Implant Ozurdex ® Outcomes.

Udaondo, Patricia; (...); Garcia-Delpech, Salvador

Article. 10.2147/OPTH.S336865. 2021

  • Open Access.

Influence of Intravitreal Therapy on Choroidal Thickness in Patients with Diabetic Macular Edema.

Udaondo Mirete P; (...); Espana-Gregori, Enrique

Article. 10.3390/jcm12010348. 2023

  • Open Access.

Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.

Pozo-Rosich P; (...); Irimia P

Article. 10.1186/s10194-024-01747-w. 2024

  • Open Access.

Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.

Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula

Article. 10.3390/antibiotics13080706. 2024

  • Open Access.

Management of flexible cavovarus foot in patients with Charcot-Marie-Tooth disease: midterm results.

Megías-Vericat JE; (...); Poveda-Andrés JL

Article. 2021

  • Open Access.

Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.

Vázquez Polo A; (...); Vázquez Costa JF

Article. 10.20960/nh.03946. 2022

  • Open Access.

Matching-Adjusted Indirect Comparison of Efficacy and Consumption of rVIII-SingleChain Versus Two Recombinant FVIII Products Used for Prophylactic Treatment of Adults/Adolescents with Severe Haemophilia A

Bonanad, S; (...); Santos, S

Article. 10.1007/s12325-021-01853-0. 2021

  • Open Access.

Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Article. 10.3390/cancers14030596. 2022

  • Open Access.

Multimodal imaging in Susac syndrome with classic clinical triad presentation.

Rahhal-Ortuño M; (...); Andreu-Fenoll M

Case Reports. 10.4103/tjo.tjo_9_20. 2021

  • Open Access.

Multi-Omic Approaches to Breast Cancer Metabolic Phenotyping: Applications in Diagnosis, Prognosis, and the Development of Novel Treatments

Gomez-Cebrian, N; (...); Pineda-Lucena, A

Review. 10.3390/cancers13184544. 2021

  • Open Access.

National Survey of the SEFH-2019: portfolio of services, healthcare activity, teaching and research in Hospital Pharmacy Services in Spain (vol 45, pg 32, 2021)

Perez-Encinas, Montserrat; (...); Angel Calleja-Hernandez, Miguel

Correction. 10.7399/fh.11740. 2021

  • Open Access.

National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies

Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis

Meeting Abstract. 10.1182/blood-2022-169938. 2022

  • Open Access.

Neurotrophic Keratopathy Treated with Topical Recombinant Human Nerve Growth Factor (Cenegermin): Case Series Study with Long-Term Follow-Up.

Garcia-Delpech, Salvador; (...); Garcia-Teillard, Damian

Article. 10.1159/000525923. 2022

  • Open Access.

New challenges of advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2023.11.008. 2024

  • Open Access.

Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus

Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis

Article. 10.1097/MD.0000000000032208. 2022

  • Open Access.

ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.

Poveda JL; (...); Badia X

Article. 10.1186/s13023-022-02610-4. 2023

  • Open Access.

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Review. 10.3390/biology12091159. 2023

  • Open Access.

OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT

Flores-Moreno, S.; (...); Gil, A.

Meeting Abstract. 2024


Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol (vol 8, 372, 2020)

Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta

Correction. 10.3389/fped.2021.834454. 2022

  • Open Access.

Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project

Morillo-Verdugo, R; (...); Diaz-Olmo, J

Article. 10.7399/fh.11719. 2021


Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project.

Morillo-Verdugo R; (...); Díaz-Olmo J

Article. 2021

  • Open Access.

Peripapillary capillary network in dominant optic atrophy linked to OPA1 gene

Rahhal-Ortuno, Miriam; (...); Espana-Gregori, Enrique

Article. 10.1177/11206721211044846. 2021


Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.

Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis

Article. 10.3390/ijms26041760. 2025

  • Open Access.

Pharmacometabolomics by NMR in Oncology: A Systematic Review.

Gómez-Cebrián N; (...); Pineda-Lucena A

Article. 10.3390/ph14101015. 2021

  • Open Access.

Pharmacotherapeutic management of advanced therapy medicinal products

Luis Poveda-Andres, Jose; (...); Valero-Garcia, Silvia

Article. 10.7399/fh.13036. 2022


Posterior Capsular Opacification and Glistening in Hydrophobic Monofocal Biaspheric Intraocular Lens Two Years After Implantation: A Case Control Study

Hervas-Ontiveros, Ana; (...); Cervino, Alejandro

Article. 10.1155/joph/3520219. 2024

  • Open Access.

Posterior scleral perforation due to endogenous endophthalmitis in a pregnant with selective IgA deficiency.

Aguilar-González M; (...); Espana-Gregori, Enrique

Article. 10.22336/rjo.2022.19. 2022

  • Open Access.

Preparation and administration of insulin infusions in neonatology: A national survey.

Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta

Article. 10.1016/j.anpede.2020.06.015. 2021

  • Open Access.

Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Poveda Andrés JL, Edo Solsona MD

Article. 10.1016/j.farma.2023.06.0131130. 2024

  • Open Access.

Prospective Study: Utility of Anterior Segment Optical Coherence Tomography to Identify Predictive Factors of Recurrence in Pterygium Surgery.

Aguilar-Gonzalez, Marina; (...); Peris-Martinez, Cristina

Article. 10.3390/jcm13164769. 2024

  • Open Access.

Purtscher-like retinopathy following carotid angioplasty and stenting in the treatment of severe carotid stenosis.

Solaz-Ruiz, M G; (...); Espana-Gregori, E

Article. 10.1177/11206721231204632. 2023


Rapid-onset voriconazole-induced cicatricial ectropion.

Pérez-López M; (...); Espana-Gregori, E

Article. 10.1016/j.jfo.2021.06.029. 2022


Rate and associations of inner retinal thinning in eyes with retinal vein occlusion and regressed macular oedema.

Cicinelli, Maria Vittoria; (...); Bandello, Francesco

Article. 10.1038/s41433-023-02647-0. 2023


Resolution of Angiographic Macular Leakage with Faricimab Versus Aflibercept in Patients with Diabetic Macular Edema in YOSEMITE/RHINE.

Goldberg, Roger A; (...); Sivaprasad, Sobha

Article. 10.1016/j.oret.2024.11.015. 2024

  • Open Access.

SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization

Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis

Article. 10.1111/jcpt.13703. 2022

  • Open Access.

Straatsma Syndrome and cataract: case report and review of the literature.

Blanca, Casado-Pelaez; (...); Enrique, Espana-Gregori

Review. 10.22336/rjo.2023.67. 2023


Systematic Review of Pharmacogenetics of ABC and SLC Transporter Genes in Acute Myeloid Leukemia

Megías-Vericat JE; (...); Montesinos P

Review. 10.3390/pharmaceutics14040878. 2022

  • Open Access.

Systemic lupus erythematosus purtscher like retinopathy: Optical coherence tomography angiography assessment implications.

Garcia-Soler E; (...); Salom-Alonso D

Article. 10.1177/11206721231171705. 2023

  • Open Access.

The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity

Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar

Article. 10.1007/s00431-022-04628-z. 2022


The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.

Gil-Nagel A; (...); Gil A

Article. 10.1016/j.yebeh.2022.108711. 2022

  • Open Access.

The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Badia, Xavier; (...); Valles, Joan-Antoni

Article. 10.1186/s13023-024-03324-5. 2024

  • Open Access.

Toxicity to intravitreal melphalan in a patient with retinoblastoma.

Solaz-Ruiz, Marta Gema; (...); Espana-Gregori, Enrique

Case Reports. 10.22336/rjo.2023.49. 2023


Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.

Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis

Article. 10.1136/ejhpharm-2024-004184. 2024


Update on Current and Future Management for Diabetic Maculopathy.

Udaondo, Patricia; (...); Chakravarthy, Usha

Article. 10.1007/s40123-022-00460-8. 2022

  • Open Access.

VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA

Poveda, J. L.; (...); Lizan, L.

Meeting Abstract. 2023


Vitrectomized vs non-vitrectomized eyes in DEX implant treatment for DMO-Is there any difference? the VITDEX study.

Iglicki, Matias; (...); Zur, Dinah

Article. 10.1038/s41433-022-01931-9. 2022


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