- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01986907
Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye (TWEYES)
A 12 Months, Prospective, Multicenter, Open-label, Single Arm Interventional Study Assessing the Safety and Tolerability of 0.5 mg Ranibizumab in Mono/Bilateral Wet AMD Patients in Eyes With (Best-Corrected Distance Visual Acuity) BCVA Below 2/10 and/or Second Affected Eye
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Borgomanero, Italia, 28021
- Novartis Investigative Site
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Galliate, Italia, 28066
- Novartis Investigative Site
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Napoli, Italia, 80131
- Novartis Investigative Site
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Napoli, Italia, 80132
- Novartis Investigative Site
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Napoli, Italia, 80138
- Novartis Investigative Site
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Pozzuoli, Italia, 80078
- Novartis Investigative Site
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AL
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Alessandria, AL, Italia, 15100
- Novartis Investigative Site
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Casale Monferrato, AL, Italia, 15033
- Novartis Investigative Site
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AN
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Ancona, AN, Italia, 60126
- Novartis Investigative Site
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BA
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Acquaviva delle Fonti, BA, Italia, 70021
- Novartis Investigative Site
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Putignano, BA, Italia, 70017
- Novartis Investigative Site
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Terlizzi, BA, Italia, 70038
- Novartis Investigative Site
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BG
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Bergamo, BG, Italia, 24127
- Novartis Investigative Site
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BL
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Belluno, BL, Italia, 32100
- Novartis Investigative Site
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BO
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Bologna, BO, Italia, 40138
- Novartis Investigative Site
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BS
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Brescia, BS, Italia, 25123
- Novartis Investigative Site
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Desenzano del Garda, BS, Italia, 25015
- Novartis Investigative Site
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BZ
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Bolzano, BZ, Italia, 39100
- Novartis Investigative Site
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CA
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Cagliari, CA, Italia, 09124
- Novartis Investigative Site
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CB
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Larino, CB, Italia
- Novartis Investigative Site
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CE
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Caserta, CE, Italia, 81100
- Novartis Investigative Site
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CH
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Chieti, CH, Italia, 66100
- Novartis Investigative Site
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CN
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Ceva, CN, Italia, 12073
- Novartis Investigative Site
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Cuneo, CN, Italia, 12100
- Novartis Investigative Site
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CO
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Como, CO, Italia, 22100
- Novartis Investigative Site
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San Feramo Della Battaglia, CO, Italia, 22020
- Novartis Investigative Site
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CT
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Acireale, CT, Italia, 95024
- Novartis Investigative Site
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Catania, CT, Italia, 95124
- Novartis Investigative Site
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Catania, CT, Italia, 95123
- Novartis Investigative Site
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CZ
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Catanzaro, CZ, Italia, 88100
- Novartis Investigative Site
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FC
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Forlì, FC, Italia, 47100
- Novartis Investigative Site
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FE
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Cona, FE, Italia, 44100
- Novartis Investigative Site
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FG
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Foggia, FG, Italia, 71100
- Novartis Investigative Site
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San Giovanni Rotondo, FG, Italia, 71013
- Novartis Investigative Site
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GE
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Genova, GE, Italia, 16132
- Novartis Investigative Site
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Genova, GE, Italia, 16153
- Novartis Investigative Site
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Rapallo, GE, Italia, 16035
- Novartis Investigative Site
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KR
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Crotone, KR, Italia, 88074
- Novartis Investigative Site
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LE
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Tricase, LE, Italia, 73039
- Novartis Investigative Site
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LT
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Terracina, LT, Italia, 04019
- Novartis Investigative Site
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ME
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Messina, ME, Italia, 98125
- Novartis Investigative Site
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Milazzo, ME, Italia, 98057
- Novartis Investigative Site
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MI
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Cinisello Balsamo, MI, Italia, 20092
- Novartis Investigative Site
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Legnano, MI, Italia, 20025
- Novartis Investigative Site
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Milano, MI, Italia, 20132
- Novartis Investigative Site
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Milano, MI, Italia, 20122
- Novartis Investigative Site
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Milano, MI, Italia, 20123
- Novartis Investigative Site
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Milano, MI, Italia, 20100
- Novartis Investigative Site
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Milano, MI, Italia, 20142
- Novartis Investigative Site
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Rozzano, MI, Italia, 20089
- Novartis Investigative Site
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Vizzolo Predabissi, MI, Italia, 20070
- Novartis Investigative Site
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NU
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Nuoro, NU, Italia, 08100
- Novartis Investigative Site
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PA
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Palermo, PA, Italia, 90127
- Novartis Investigative Site
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Palermo, PA, Italia, 90146
- Novartis Investigative Site
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PC
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Piacenza, PC, Italia, 29100
- Novartis Investigative Site
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PD
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Camposampiero, PD, Italia, 35012
- Novartis Investigative Site
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Monselice, PD, Italia, 35043
- Novartis Investigative Site
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Padova, PD, Italia, 35128
- Novartis Investigative Site
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Padova, PD, Italia, 35100
- Novartis Investigative Site
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PE
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Pescara, PE, Italia, 65124
- Novartis Investigative Site
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PG
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Citta' di Castello, PG, Italia, 06012
- Novartis Investigative Site
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Foligno, PG, Italia, 06034
- Novartis Investigative Site
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Perugia, PG, Italia, 06100
- Novartis Investigative Site
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PN
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Pordenone, PN, Italia, 33170
- Novartis Investigative Site
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PR
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Parma, PR, Italia, 43100
- Novartis Investigative Site
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PV
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Pavia, PV, Italia, 27100
- Novartis Investigative Site
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RC
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Reggio Calabria, RC, Italia, 89124
- Novartis Investigative Site
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RE
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Correggio, RE, Italia, 42015
- Novartis Investigative Site
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Reggio Emilia, RE, Italia, 42123
- Novartis Investigative Site
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RM
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Civitavecchia, RM, Italia, 00053
- Novartis Investigative Site
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Roma, RM, Italia, 00168
- Novartis Investigative Site
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Roma, RM, Italia, 00161
- Novartis Investigative Site
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Roma, RM, Italia, 00133
- Novartis Investigative Site
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Roma, RM, Italia, 00184
- Novartis Investigative Site
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Roma, RM, Italia, 00189
- Novartis Investigative Site
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Roma, RM, Italia, 00186
- Novartis Investigative Site
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RN
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Riccione, RN, Italia, 47838
- Novartis Investigative Site
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SA
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Eboli, SA, Italia, 84025
- Novartis Investigative Site
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Salerno, SA, Italia, 84131
- Novartis Investigative Site
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SO
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Sondrio, SO, Italia, 23100
- Novartis Investigative Site
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SP
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Sarzana, SP, Italia, 19038
- Novartis Investigative Site
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SS
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Sassari, SS, Italia, 07100
- Novartis Investigative Site
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SV
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Savona, SV, Italia, 17100
- Novartis Investigative Site
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TA
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Taranto, TA, Italia, 74100
- Novartis Investigative Site
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TE
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Teramo, TE, Italia, 64100
- Novartis Investigative Site
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TO
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Torino, TO, Italia, 10122
- Novartis Investigative Site
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Torino, TO, Italia, 10153
- Novartis Investigative Site
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Torino, TO, Italia, 10152
- Novartis Investigative Site
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TR
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Terni, TR, Italia, 05100
- Novartis Investigative Site
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TS
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Trieste, TS, Italia, 34129
- Novartis Investigative Site
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TV
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Conegliano, TV, Italia, 31015
- Novartis Investigative Site
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Treviso, TV, Italia, 31100
- Novartis Investigative Site
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UD
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Udine, UD, Italia, 33100
- Novartis Investigative Site
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VA
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Busto Arsizio, VA, Italia, 21052
- Novartis Investigative Site
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Somma Lombardo, VA, Italia, 21019
- Novartis Investigative Site
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Varese, VA, Italia, 21100
- Novartis Investigative Site
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VI
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Santorso, VI, Italia, 36014
- Novartis Investigative Site
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Vicenza, VI, Italia, 36100
- Novartis Investigative Site
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VR
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Legnago, VR, Italia, 37045
- Novartis Investigative Site
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Negrar, VR, Italia, 37024
- Novartis Investigative Site
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Verona, VR, Italia, 37126
- Novartis Investigative Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria
Male or female patients aged 50 years or above Willing and capable to provide informed written consent Eye(s) eligible for ranibizumab treatment, with a BCVA below 2/10 due to wet AMD and/or Second eye eligible for ranibizumab treatment, with first eye treated (currently or previously) with ranibizumab, whichever BCVA. In bilateral wAMD patients, the second eye can be included only if the first eye has been treated at least 14 days before with ranibizumab
Exclusion Criteria:
Active intraocular inflammation (grade trace or above) in either eye Any ocular or periocular active infection (current or suspected), e.g. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis, in either eye Risk factors for retinal pigment epithelial tear (including pigment epithelial retinal detachment) Ocular disorders that may confound interpretation of results compromise visual acuity or require medical or surgical intervention during the study period including cataract, retinal vascular occlusion, retinal detachment or macular hole Uncontrolled glaucoma in either eye (IOP ≥ 30 mmHg on medication or according to investigator's judgment) History of vitrectomy in the study eye History of stroke or transient ischemic attack Systemic treatment with any VEGF inhibitor in the 90 days prior to study enrollment Ocular treatment of the study eye with any anti-angiogenic drugs within 1 month prior to study enrollment Any intraocular surgery in the study eye within 28 days prior to enrollment Women of childbearing potential UNLESS using effective contraception during treatment Pregnant or lactating women Simultaneous participation in a study that includes administration of any investigational drug Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Inability to comply with study procedures.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Ranibizumab
Administered as an Intravitreal injection
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All patients will receive ranibizumab 0.5 mg/0.05 ml according to approved label: treatment is given monthly until maximum VA is achieved (i.e.
stable VA for three consecutive monthly assessments performed while on ranibizumab treatment).
Thereafter according to approved label, patients should be monitored monthly for visual acuity and treatment is to be resumed when monitoring indicates loss of visual acuity due to disease activity.
Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants With Systemic Drug-related Adverse Events
Periodo de tiempo: Baseline to Month 12
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Monitoring and recording all adverse events, including serious adverse events.
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Baseline to Month 12
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Number of Eyes With Ocular Drug-related Adverse Events
Periodo de tiempo: Baseline to Month 12
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Monitoring and recording all adverse events, including serious adverse events.
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Baseline to Month 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Overall Number of Ranibizumab Injections
Periodo de tiempo: Baseline to month 12
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Baseline to month 12
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Time Interval Between Injections in Bilateral Disease
Periodo de tiempo: Baseline to month 12
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Mean number of days between two consecutive injections per eye
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Baseline to month 12
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Mean Number of Injections Per Patient
Periodo de tiempo: Baseline to month 12
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Number of injections per patient
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Baseline to month 12
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CRFB002AIT02
- 2013-003333-15 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre ranibizumab
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University of Campania "Luigi Vanvitelli"Terminado
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University of Illinois at ChicagoGenentech, Inc.RetiradoGlaucoma | Glaucoma neovascular | Glaucoma de nueva aparición | Glaucoma Neovascular de Nuevo Inicio
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Especialistas en Retina Medica y Quirurgica Grupo...Centro de Retina Medica y Quirurgica S.C.TerminadoEdema macular diabéticoArgentina, México
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Lupin Ltd.ReclutamientoDegeneración macular relacionada con la edad neovascularIndia
-
Hawaii Pacific HealthGenentech, Inc.TerminadoVasculopatía coroidea polipoidea | PCVEstados Unidos
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New England Retina AssociatesGenentech, Inc.TerminadoMelanoma coroideoEstados Unidos
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Samsung Bioepis Co., Ltd.TerminadoLa degeneración macular relacionada con la edadCorea, república de, Estados Unidos, India, Alemania, Hungría, Reino Unido, Chequia, Polonia, Federación Rusa
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Instituto de Olhos de GoianiaTerminadoEnfermedades de la retina
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NovartisTerminadoLa degeneración macular relacionada con la edadSuiza
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Vista KlinikTerminadoLa degeneración macular relacionada con la edad | Neovascularización coroideaSuiza