- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01988246
Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery (PROMISE)
12 de mayo de 2020 actualizado por: Rishi Singh
To determine the safety and efficacy of intravitreal Aflibercept (Eylea) injection in patients with diabetic retinopathy in the prevention of macular edema following cataract surgery.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Diabetic retinopathy patients who are at risk of developing macular edema (defined as ≥ 30 % increase from pre-operative baseline in central subfield macular thickness) within 90 days following cataract surgery.
Diabetic patients are defined as those who have either Type 1 or Type 2 diabetes.
The patients must have either mild, moderate, or severe non proliferative retinopathy or treated proliferative retinopathy.
Patients must be 18 years of age and older, of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens into the lens capsule.
Tipo de estudio
Intervencionista
Inscripción (Actual)
30
Fase
- Fase 2
- Fase 1
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
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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
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:
A patient must meet the following criteria to be eligible for inclusion in the study:
- Must be 18 years of age and older, of any race and either sex, who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens into the lens capsule
- History of Type I or Type II diabetes
- NPDR: non-proliferative diabetic retinopathy (mild, moderate, or severe) or inactive proliferative disease in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale
- Willing and able to comply with clinic visits and study-related procedures
- Patients must be able to understand and sign an informed consent that has been approved by an Institutional Review Board (IRB)
- Central subfield macular thickness ≤ 320 μm in the study eye prior to cataract surgery as determined by SD-OCT and confirmed by the reading center
- Absence of clinically significant macular edema (CSME) in the study eye as detected by clinical exam
- Patients must have visual acuity of 20/20-20/200
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from the study:
- Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by reading center or investigator
- Current or previous ocular disease in the study eye that in the opinion of the investigator may confound assessment of the macula, the retina, or central vision other that diabetic retinopathy
- Active proliferative diabetic retinopathy in the study eye
- Planned multiple procedures for study eye during the cataract/IOL implantation surgery (e.g., trabeculectomy, corneal transplant)
- Patients who have received corneal transplants in the study eye
- Patients with current or history of chronic or recurrent ocular infections or inflammation in the study eye
- Patients with a visually nonfunctional fellow eye based upon the assessment by the investigator
- Patients who are immunocompromised (e.g., patients receiving chemotherapy irradiation therapy, patients with AIDS, leukemia, or cachexia) or patients receiving dialysis
- Use of medications known to affect the macula, including hydroxychloroquinine (Plaquenil) and phenothiozines (e.g., thioridazine [Mellaril], chloropromazine [Thorazine]) or supplemental niacin ≥3 grams/day
- Use of systemic steroids, NSAIDS (non-steroidal anti-inflammatory drugs), anti-VEGF agents within 7 days prior to surgery (through study exit). Daily doses of aspirin, up to 325 mg, will be permitted.
- Use of topical ocular NSAIDS and steroids, in the study eye, within 7 days prior to surgery
- Treatment with intraocular or periocular steroids in the study eye within 3 months prior to surgery
- Focal photocoagulation for the treatment of diabetic macular edema in the study eye within 6 months of the pre-operative baseline visit (Note: peripheral retina treatment for retinal tear or lattice degeneration is permitted)
- Intravitreal anti-VEGF (vascular endothelial growth factor) treatment in the study eye within 6 months of the pre-operative baseline visit
- Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication.
- Use of a topical ophthalmic prostaglandin (e.g., TRAVATAN, XALATAN) within 4 days of surgery through study exit
- Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could require either medical or surgical intervention during the 90 day study period.
- Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient 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.
- Pregnant or breast-feeding women -
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador falso: Sham Injection
Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery.
The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration.
This will be administered post cataract excision by the Prinicipal Investigator.
The patient will be masked as to which Arm they are assigned.
|
Sham injection.
No actual injection.
No medication is used.
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Comparador activo: Intravitreal Aflibercept Injection
Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery.
This will be administered post cataract excision by the Principal Investigator.
The patient will be masked as to which Arm they are assigned.
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Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants With Ocular and Non-Ocular Adverse Events
Periodo de tiempo: Day 90
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Number of participants with ocular and non-ocular adverse events (AEs) in both treatment arms.
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Day 90
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score
Periodo de tiempo: Day 90
|
Change from baseline in best-corrected visual acuity (BCVA) score and BCVA score at Day 90 as measured by ETDRS (early treatment diabetic retinopathy study) 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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Day 90
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline in Retinal Thickness
Periodo de tiempo: Day 90
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The change in macular edema as measured by SD-OCT (spectral domain ocular coherence tomography)at 90 days
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Day 90
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rishi Singh, M.D., Cole Eye Institute, Cleveland Clinic
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 diciembre de 2013
Finalización primaria (Actual)
25 de abril de 2018
Finalización del estudio (Actual)
14 de enero de 2020
Fechas de registro del estudio
Enviado por primera vez
30 de octubre de 2013
Primero enviado que cumplió con los criterios de control de calidad
13 de noviembre de 2013
Publicado por primera vez (Estimar)
20 de noviembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de mayo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
12 de mayo de 2020
Última verificación
1 de mayo de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades de los ojos
- Enfermedades del sistema endocrino
- Angiopatías diabéticas
- Complicaciones de la diabetes
- Diabetes mellitus
- Degeneración retinal
- Degeneración macular
- Enfermedades del cristalino
- Enfermedades de la retina
- Retinopatía diabética
- Edema macular
- Catarata
- 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
- PROMISE Trial
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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. .
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