- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01617148
Wet Macular Degeneration Study to Compare Ranibizumab or Bevacizumab to Aflibercept
A Single Arm, Investigator Initiated Study of the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Injection in Subjects With Exudative Age-related Macular Degeneration Previously Treated With Ranibizumab or Bevacizumab (ASSESS Study)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cole Eye Institute, Cleveland Clinic
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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
A subject must meet the following criteria to be eligible for inclusion in the study:
- Signed Informed Consent.
- Men and women ≥ 50 years of age.
- Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by historical optical coherence tomographies (OCTs) and angiograms in the study eye.
- CNV must be at least 50% of total lesion size by either previous or current angiogram.
- ETDRS best-corrected visual acuity of: 20/25 to 20/320 (letter score of 73 to 25) in the study eye.
- Willing, committed, and able to return for all clinic visits and complete all study related procedures.
- At least one injection of Ranibizumab or Bevacizumab within 3 months of enrollment for active exudative AMD.
Active need for anti- vascular endothelial growth factor (anti-VEGF) therapy at study entry based on the following criteria:
- Presence of fluid by either optical coherence tomography (OCT) or clinical examination (further defined as intraretinal, cystoid, subretinal, worsening pigment epithelial detachment)
- Presence of new hemorrhage on clinical examination
Exclusion Criteria
A subject who meets any of the following criteria will be excluded from the study:
- Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins.
- Prior systemic anti-VEGF therapy, investigational or FDA/Health Canada approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study.
- Presence of retinal pigment epithelial tears or rips involving the macula in the study
- History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
- Presence of other causes of CNV, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye.
- History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.
- Prior vitrectomy in the study eye.
- History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
- Any history of macular hole of stage 2 and above in the study eye.
- Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as it's unlikely to interfere with the injection.
- Prior trabeculectomy or other filtration surgery in the study eye.
- Uncontrolled glaucoma at baseline evaluation (defined as intraocular pressure ≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
- Active intraocular inflammation in either eye.
- Active ocular or periocular infection in either eye.
- Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.
- Any history of uveitis in either eye.
- Active scleritis or episcleritis in either eye.
- Presence or history of scleromalacia in either eye.
- Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye.
- Previous therapeutic radiation in the region of the study eye.
- History of corneal transplant or corneal dystrophy in the study eye.
- Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of safety, or fundus photography.
- Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 52 week study period.
- Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
- Participation as a subject in any clinical study within the 12 weeks prior to Day 1.
- Any systemic with an investigational agent in the past 3 months prior to Day 1.
- The use of long acting intraocular steroids or photodynamic therapy in the 6 months prior to day 1.
- Any history of allergy to povidone iodine.
- Pregnant or breast-feeding women
Women of childbearing potential* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
- *Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- 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: Treatment with Aflibercept
Subjects were given 2 mg (0.05 mL) of intravitreal aflibercept injection administered every month for the first 3 months, followed by 2 mg (0.05 mL) once every 2 months as per the drug label for the next 9 months.
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Patients received 2 mg (0.05 mL) of intravitreal aflibercept injection administered monthly for the first 3 months, followed by 2 mg (0.05 mL) once every 2 months as per the drug label for the next 9 months.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Central Subfield Thickness From Baseline at 12 Months
Periodo de tiempo: baseline and 12 months
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The mean absolute change from baseline central subfield thickness at 12 months as measured by SDOCT
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baseline and 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Best-corrected Visual Acuity From Baseline at 12 Months
Periodo de tiempo: Baseline and 12 months
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The mean absolute change from baseline in best-corrected visual acuity score at 12 months as measured by Eletronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) protocol.
There were no sub scales used.
These are common methods for ophthalmology studies to report their findings.
The scale provided is the Electronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) best corrected visual acuity scale.
Values that are higher are considered better and values that are lower are considered worse.
Minimum E-ETDRS was 24 E-ETDRS letters and maximum E-ETDRS was 80 E-ETDRS letters.
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Baseline and 12 months
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Change in Macular Volume From Baseline at 12 Months.
Periodo de tiempo: baseline and 12 months
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Mean absolute change from baseline in macular volume at 12 months.
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baseline and 12 months
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Change in Cube Average Thickness From Baseline at 12 Months
Periodo de tiempo: baseline and 12 months
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Mean absolute change in cube average thickness as measured by SDOCT from baseline at 12 months.
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baseline and 12 months
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Percentage of Patients Who Gained Greater Than 15 Letters of Vision From Baseline at 12 Months.
Periodo de tiempo: baseline and 12 months
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The percentage of patients who gained greater than 15 letters of vision from baseline to 12 months.
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baseline and 12 months
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Percentage of Patients Who Lost Greater Than 15 Letters of Vision From Baseline at 12 Months
Periodo de tiempo: baseline and 12 months
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The percentage of patients who lost greater than 15 letters of vision from baseline at 12 months.
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baseline and 12 months
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Percentage of Subjects Who Were 20/40 or Better at Month 12.
Periodo de tiempo: month 12
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Percentage of subjects who had vision acuity of 20/40 or better at month 12.
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month 12
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Percentage of Subjects Who Were 20/200 or Worse at Month 12.
Periodo de tiempo: month 12
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Percentage of subjects who had visual acuity of 20/200 or worse at month 12.
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month 12
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rishi P Singh, MD, The Cleveland Clinic
Publicaciones y enlaces útiles
Publicaciones Generales
- Singh RP, Srivastava SK, Ehlers JP, Silva FQ, Bedi R, Schachat AP, Kaiser PK. A single-arm, investigator-initiated study of the efficacy, safety, and tolerability of intravitreal aflibercept injection in subjects with exudative age-related macular degeneration previously treated with ranibizumab or bevacizumab (ASSESS study): 12-month analysis. Clin Ophthalmol. 2015 Sep 22;9:1759-66. doi: 10.2147/OPTH.S87043. eCollection 2015. Erratum In: Clin Ophthalmol. 2017 Feb 07;11:303.
- Singh RP, Srivastava S, Ehlers JP, Bedi R, Schachat AP, Kaiser PK. A single-arm, investigator-initiated study of the efficacy, safety and tolerability of intravitreal aflibercept injection in subjects with exudative age-related macular degeneration, previously treated with ranibizumab or bevacizumab: 6-month interim analysis. Br J Ophthalmol. 2014 Jun;98 Suppl 1(Suppl 1):i22-27. doi: 10.1136/bjophthalmol-2013-304798.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
- Enfermedades de los ojos
- Degeneración retinal
- Enfermedades de la retina
- Degeneración macular
- Degeneración macular húmeda
- Efectos fisiológicos de las drogas
- Agentes antineoplásicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Aflibercept
Otros números de identificación del estudio
- VGFTe-AMD-1211
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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 Degeneración macular exudativa
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AiViva BioPharma, Inc.ReclutamientoEdema macular diabético | Degeneración macular relacionada con la edad neovascularEstados Unidos
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Hoffmann-La RocheTerminadoEdema macular diabético | Degeneración macular relacionada con la edad neovascularEstados Unidos
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EyeBiotech Ltd.ReclutamientoEdema macular diabético (EMD) | Degeneración macular relacionada con la edad neovascular (NVAMD)Estados Unidos, Argentina, Puerto Rico, Reino Unido
Ensayos clínicos sobre Aflibercept
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Regeneron PharmaceuticalsSanofiTerminadoTumores sólidosEstados Unidos, Canadá
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CR-CSSS Champlain-Charles-Le MoyneSanofi; Regeneron Pharmaceuticals; Quebec Clinical Research Organization in CancerTerminadoCáncer colorrectal metastásicoCanadá
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Indonesia UniversityBayerTerminadoRetinopatía diabética | Edema macular diabético | Edema macular clínicamente significativoIndonesia
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Samsung Bioepis Co., Ltd.TerminadoDegeneración macular relacionada con la edad neovascularChequia, Estonia, Hungría, Corea, república de, Letonia, Polonia, Estados Unidos, Croacia, Japón, Federación Rusa
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Alvotech Swiss AGActivo, no reclutandoAMD neovascular (húmeda)Eslovaquia, Chequia, Georgia, Japón, Letonia
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Bioeq GmbHTerminadoDegeneración macular relacionada con la edad neovascularBulgaria, Italia, Polonia, Federación Rusa, Hungría, Ucrania, Japón, Israel, Chequia
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SanofiRegeneron PharmaceuticalsTerminadoNeoplasias | Cáncer de ovarioEstados Unidos, Francia, Canadá, Australia, Alemania, Italia, Países Bajos, Portugal, España, Suecia, Suiza
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SanofiRegeneron PharmaceuticalsTerminadoNeoplasias OváricasEstados Unidos, Italia, Suecia
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SanofiRegeneron PharmaceuticalsTerminadoNeoplasias De Pulmón | Enfermedades PulmonaresEstados Unidos, Francia, Canadá
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Instituto de Olhos de GoianiaTerminadoEnfermedades de la retina