Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus (RETAIN)

10 de septiembre de 2014 actualizado por: Novartis Pharmaceuticals

A 2 Year Randomized, Single-masked, Multicenter, Controlled Phase IIIb Trial Assessing the Efficacy and Safety of 0.5 mg Ranibizumab in Two "Treat and Extend" Treatment Algorithms vs. 0.5 mg Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus

The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

373

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Bélgica
      • Gent, Bélgica, 9000
        • Novartis Investigative Site
      • Kortrijk, Bélgica, 8500
        • Novartis Investigative Site
      • Leuven, Bélgica, 3000
        • Novartis Investigative Site
  • España
      • Las Palmas de Gran Canaria, España, 35016
        • Novartis Investigative Site
      • Madrid, España, 28040
        • Novartis Investigative Site
    • Andalucia
      • Málaga, Andalucia, España, 29010
        • Novartis Investigative Site
    • Castilla y Leon
      • Valladolid, Castilla y Leon, España, 47011
        • Novartis Investigative Site
    • Cataluña
      • L'Hospitalet de Llobregat, Cataluña, España, 08907
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, España, 03016
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, España, 46015
        • Novartis Investigative Site
    • Galicia
      • Santiago de Compostela, Galicia, España, 15705
        • Novartis Investigative Site
  • Francia
      • Bordeaux, Francia, 33 000
        • Novartis Investigative Site
      • Dijon, Francia, 21034
        • Novartis Investigative Site
      • Lille, Francia, 59 037
        • Novartis Investigative Site
      • Limoges Cedex, Francia, 87042
        • Novartis Investigative Site
      • Lyon, Francia, 69003
        • Novartis Investigative Site
      • Nantes Cedex 1, Francia, 44093
        • Novartis Investigative Site
      • Nice, Francia, 6 000
        • Novartis Investigative Site
      • Paris, Francia, 75015
        • Novartis Investigative Site
      • Paris cedex 10, Francia, 75475
        • Novartis Investigative Site
  • Grecia
      • Athens, Grecia, 152 31
        • Novartis Investigative Site
      • Thessaloniki, Grecia, 546 36
        • Novartis Investigative Site
    • Crete
      • Heraklion Crete, Crete, Grecia, GR-71110
        • Novartis Investigative Site
  • Hungría
      • Budapest, Hungría, 1083
        • Novartis Investigative Site
      • Budapest, Hungría, 1133
        • Novartis Investigative Site
      • Debrecen, Hungría, 4012
        • Novartis Investigative Site
      • Gyor, Hungría, 9024
        • Novartis Investigative Site
  • Irlanda
      • Dublin, Irlanda
        • Novartis Investigative Site
      • Dublin 7, Irlanda
        • Novartis Investigative Site
      • Kilkenny, Irlanda
        • Novartis Investigative Site
      • Limerick, Irlanda
        • Novartis Investigative Site
  • Italia
    • FI
      • Firenze, FI, Italia, 50134
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italia, 20132
        • Novartis Investigative Site
      • Milano, MI, Italia, 20122
        • Novartis Investigative Site
      • Milano, MI, Italia, 20157
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italia, 00133
        • Novartis Investigative Site
      • Roma, RM, Italia, 00198
        • Novartis Investigative Site
  • Países Bajos
      • Amsterdam, Países Bajos, 1081 HV
        • Novartis Investigative Site
      • Amsterdam, Países Bajos, 1105 AZ
        • Novartis Investigative Site
      • Leiden 2333 ZA, Países Bajos, 2333
        • Novartis Investigative Site
      • Nijmegen, Países Bajos, 6525 EX
        • Novartis Investigative Site
      • Rotterdam, Países Bajos, 3011 BH
        • Novartis Investigative Site
  • Polonia
      • Bielsko-Biala, Polonia, 43-300
        • Novartis Investigative Site
      • Lublin, Polonia, 20-954
        • Novartis Investigative Site
      • Warszawa, Polonia, 00-416
        • Novartis Investigative Site
      • Wroclaw, Polonia, 50-367
        • Novartis Investigative Site
  • Portugal
      • Coimbra, Portugal, 3000-354
        • Novartis Investigative Site
      • Lisboa, Portugal, 1150-199
        • Novartis Investigative Site
      • Porto, Portugal, 4099-001
        • Novartis Investigative Site
  • Reino Unido
      • Aberdeen, Reino Unido, AB25 2ZN
        • Novartis Investigative Site
      • Bristol, Reino Unido, BS1 2LX
        • Novartis Investigative Site
      • Leeds, Reino Unido, LS9 7TF
        • Novartis Investigative Site
      • Manchester, Reino Unido, M13 9WL
        • Novartis Investigative Site
      • Newcastle Upon Tyne, Reino Unido, NE1 4LP
        • Novartis Investigative Site
      • Sheffield, Reino Unido, S10 2JF
        • Novartis Investigative Site
      • Southampton, Reino Unido, SO16 6YD
        • Novartis Investigative Site
      • Sunderland, Reino Unido, SR2 9HP
        • Novartis Investigative Site
      • Wolverhampton, Reino Unido, WV10 0QP
        • Novartis Investigative Site
    • Surrey
      • Frimley, Surrey, Reino Unido, GU16 7UJ
        • Novartis Investigative Site
  • República Checa
      • Hradec Kralove, República Checa, 505 05
        • Novartis Investigative Site
      • Olomouc, República Checa, 775 20
        • Novartis Investigative Site
      • Plzen, República Checa, 301 00
        • Novartis Investigative Site
      • Prague 2, República Checa, 128 08
        • Novartis Investigative Site
      • Praha 6, República Checa, 169 02
        • Novartis Investigative Site
  • Suiza
      • Bern, Suiza, 3010
        • Novartis Investigative Site
      • Bern, Suiza, 3012
        • Novartis Investigative Site
      • Binningen, Suiza, 4102
        • Novartis Investigative Site
      • Zürich, Suiza, 8063
        • Novartis Investigative Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Patient

  • Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes Association or World Health Organization [WHO] guidelines) with glycosylated hemoglobin (HbA1c) ≤ 12.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes. Treatment for diabetes must have been stable for at least 3 month.

Ocular

  • Patients with visual impairment due to DME in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected by the investigator as the study eye.
  • BCVA ≥ 39 and ≤78 letters in the study eye and, inclusively, using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160) at screening.
  • Concomitant conditions in the study eye are only permitted if, in the opinion of the investigator, they do not prevent improvement of visual acuity on study treatment.

Exclusion Criteria:

Patient Compliance/ Administrative

  • Pregnant or nursing (lactating) women.

Ocular medical history

  • Active intraocular inflammation (grade trace or above) in either eye at enrollment.
  • Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye at the time of enrollment.
  • History of uveitis in either eye at any time.
  • Structural damage within 0.5 disc diameter of the center of the macular in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema.
  • Uncontrolled glaucoma in either eye at screening.

Prior Ocular treatments

  • Panretinal laser photocoagulation in the study eye within 6 months prior to randomization.
  • Focal/grid laser photocoagulation in the study eye within 3 months prior to randomization.
  • Treatment with anti-angiogenic drugs in either eye.

Systemic conditions or treatments

  • History of stroke within 6 months prior to enrollment.
  • Renal failure requiring dialysis.
  • Untreated diabetes mellitus.
  • Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg.

Other protocol-defined inclusion/exclusion criteria may apply

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: TE Ranibizumab 0.5 mg and Laser
On Day 1, all patients received an intravitreal injection with 0.5 mg ranibizumab and subsequently entered Phase A which comprised of monthly injections. Laser therapy was applied at Day 1. It could then be re-administered according to ETDRS criteria at any visit with 0.5 mg ranibizumab treatment if deemed necessary by the Treating Investigator with a minimal treatment interval between laser treatments of 3 months. Laser therapy was administered ≥ 30 minutes prior to the ranibizumab injection.
Droga: Ranibizumab
Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.
Experimental: TE Ranibizumab 0.5 mg alone
Patients received ranibizumab intravitreal injection therapy only.
Droga: Ranibizumab
Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.
Comparador activo: PRN Ranibizumab 0.5 mg
Patients received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Droga: Ranibizumab
Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
Periodo de tiempo: Baseline to Month 12
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Baseline to Month 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24
Periodo de tiempo: Baseline to Month 24
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Baseline to Month 24
Visual Acuity of the Study Eye: Change From Baseline at Month 12
Periodo de tiempo: Baseline and Month 12
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Baseline and Month 12
Visual Acuity of the Study Eye: Change From Baseline at Month 24
Periodo de tiempo: Baseline and Month 24
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Baseline and Month 24
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12
Periodo de tiempo: Baseline, Month 12
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Baseline, Month 12
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24
Periodo de tiempo: Baseline, 24 month
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Baseline, 24 month
Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12
Periodo de tiempo: Baseline, Month 12
High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
Baseline, Month 12
Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24
Periodo de tiempo: Baseline and 24 month
High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
Baseline and 24 month
Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24
Periodo de tiempo: Baseline, Month 12 and Month 24
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and symptoms on general health. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. Each response was recoded per the scoring rules outlined in the National Eye Institute (NEI) VFQ-25 Scoring Algorithm. Under this scoring algorithm , the recoded values range between 0 and 100 and a high score means a better functioning
Baseline, Month 12 and Month 24
EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24
Periodo de tiempo: Baseline, Month 12 and Month 24
The Euro Quality of Life Questionnaire (EQ-5D) is an indirect utility questionnaire. It is a standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1= "no problems", 2="some problems" and 3="extreme problems" . A composite health index was then defined by combining the levels for each dimension. Overall, 243 health states are possible. For each health state, the EuroQol group has assigned a utility value typically between 0 and 1 with lower scores representing a higher level of dysfunction
Baseline, Month 12 and Month 24

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2010

Finalización primaria (Actual)

1 de abril de 2013

Finalización del estudio (Actual)

1 de abril de 2013

Fechas de registro del estudio

Enviado por primera vez

27 de julio de 2010

Primero enviado que cumplió con los criterios de control de calidad

27 de julio de 2010

Publicado por primera vez (Estimar)

29 de julio de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

15 de septiembre de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

10 de septiembre de 2014

Última verificación

1 de septiembre de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CRFB002D2304
  • 2010-019795-74 (Número EudraCT)

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 Edema macular diabético

Ensayos clínicos sobre Ranibizumab

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Thailand

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir