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

Biobanco de Uveítis/Enfermedad Inflamatoria Intraocular (iBank)

3 de noviembre de 2026 actualizado por: National Eye Institute (NEI)

Background:

Uveitis is a serious eye disease that can cause vision loss. Treatment sometimes causes serious side effects or does not work. Researchers want to learn more about uveitis and why some people develop it.

Objective:

To learn clinical and genetic factors that may make people develop uveitis and influence how they respond to treatment.

Eligibility:

People ages 8 and older who have uveitis, scleritis, inflammatory eye disease, or a disease related to eye inflammation

INCLUSION CRITERIA FOR COVID-19 COHORT:

Participants with COVID-19 will be eligible if they:

  1. Have a diagnosis of COVID-19 confirmed by a nasaopharyngeal swab (or another confirmative test) within less than or equal to 3 days prior, with symptoms of any severity.
  2. Are able to give verbal consent.
  3. Are 16 years of age or older.

EXCLUSION CRITERIA FOR COVID-19 COHORT:

Participants with COVID-19 will not be eligible if they:

  1. Use regular prescription eye drops on the day of sampling.
  2. Current use of antiviral medications.

Design:

Participants will be screened with:

Medical history

Physical exam

Eye exam

Participation lasts up to 10 years. The clinic visit schedule varies depending on participants eye disease:

Baseline visit with annual follow-ups

Baseline visit, visits at months 3 and 6, and annual follow-ups

Another schedule set by the researcher

Depending on participants eye disease, tests during each visit could include:

Fluorescein angiography or indocyanine green angiography: Dye is injected through a needle in the arm

and flows through the blood vessels in the eye. A camera takes pictures of the eye.

Electroretinography: Participants sit in the dark with their eyes patched.

After 30 minutes, numbing drops and contact lenses are put in the eyes. Then, the retina is stimulated with flashing lights.

Perimetry: Participants look into a bowl or lens and press a button when they see a light.

Conjunctival or corneal biopsy, or skin biopsy: A small piece of tissue is removed.

Anterior chamber tap: A needle enters the eye to remove fluid.

Blood and urine tests

Saliva, stool, hair, or tear samples

Cotton swab of the inside of the cheek.

During the study, participants may need immunosuppressive treatment, such as drugs or injections in or around the eyes depending on their disease.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Uveitis refers to a large group of intraocular inflammatory diseases that can cause devastating visual loss in adults and children. This study establishes a clinical database and biospecimen repository for the identification of novel factors relevant to the pathogenesis, progression, and response to treatment of a wide spectrum of uveitic conditions.

Objectives: This study provides for standardized collection of longitudinal clinical data and for serial collection, processing, and storage of a variety of biospecimens. The clinical data set and biospecimen repository will be used to identify novel genetic factors, biomarkers, and experimental models associated with pathogenesis, progression, and response to treatment for various ocular and systemic conditions where inflammation of the uveal tract is present.

Study Population: The study plans to accrue 550 participants with uveitis or related diseases. This will not be restricted by anatomical location or etiology with the inclusion of both idiopathic cases, infectious uveitis, scleritis and those cases linked to a disease known to be associated with an increased risk of intraocular inflammation (e.g., sarcoidosis, Beh(SqrRoot) (Beta)et's disease and multiple sclerosis (MS) and lymphoma). In addition, 100 participants without intraocular inflammatory disease will be enrolled as controls.

Design: This is a prospective observational study of participants with intraocular inflammatory diseases incorporating: 1. A standardized follow-up and testing schedule with standard-of-care management of eye diseases; and/or 2. Collection of biospecimens for research purposes for which sampling does not incur more than minimal risk to participants. Outcome Measures: Outcome measures include the interaction of key parameters of disease phenotype (such as visual acuity and ocular imaging features) with genetic variants and other biomarkers identified from biospecimens and the characterization of new experimental models of eye health and disease.

Tipo de estudio

De observación

Inscripción (Actual)

343

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

  • Estados Unidos
    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20892
        • National Institutes of Health Clinical Center

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

8 años a 100 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

The study plans to accrue 550 participants with uveitis or related diseases. This will not be restricted by anatomical location or etiology with the inclusion of both idiopathic cases, infectious uveitis, scleritis and those cases linked to a disease known to be associated with an increased risk of intraocular inflammation (e.g., sarcoidosis, Beh(SqrRoot)(Beta)et's disease, multiple sclerosis (MS) and lymphoma). In addition, 100 participants without intraocular inflammatory disease will be enrolled as controls.

Descripción

  • INCLUSION CRITERIA (NOT APPLICABLE TO COVID COHORT):

Participants will be eligible if they:

  1. Have a diagnosis of uveitis, scleritis or a disease known to be associated with intraocular inflammation, (e.g., sarcoidosis, Behcet's disease, MS and lymphoma) OR could serve as an unaffected control.

  2. Are eight years of age or older if an affected participant.

  3. Are 18 years of age or older if serving as an unaffected control.

  4. For participants 18 years of age and older:

    • Are willing to give informed consent that includes collection and study of at least one peripheral blood sample.

EXCLUSION CRITERIA (NOT APPLICABLE TO COVID COHORT):

Participants will not be eligible if they:

  1. Are unable to understand and sign the informed consent form.

  2. Are unable or unwilling to give informed consent that includes use of medical records and clinical samples for current and future research related to vision and diseases affecting the eyes.

  3. Have a systemic disease that compromises the ability to provide adequate ophthalmologic examination or treatment as determined by the investigator.

  4. For participants with uveitis:

    • Have inactive anterior uveitis or quiescent infectious uveitis not requiring such regimented and intensive standardized testing as determined by the Investigator.
    • Have end stage or chronic quiescent changes in the setting of an established infectious etiology, such as an old ocular toxoplasma scar (participants with active intraocular inflammation due to infection will be recruited).

The eligibility requirements for this protocol are intended to be broadly inclusive, but those individuals screened at the NEI and found to be ineligible may be evaluated under the NEI Screening Protocol for potential participation in other studies.

INCLUSION CRITERIA FOR COVID-19 COHORT:

Participants with COVID-19 will be eligible if they:

  1. Have a diagnosis of COVID-19 confirmed by a nasopharyngeal swab (or another confirmative test) within less than or equal to 3 days prior, with symptoms of any severity.
  2. Are able to give verbal consent.
  3. Are 16 years of age or older.

EXCLUSION CRITERIA FOR COVID-19 COHORT:

Participants with COVID-19 will not be eligible if they:

  1. Use regular prescription eye drops on the day of sampling.
  2. Current use of antiviral medications.

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

  • Modelos observacionales: COHORT
  • Perspectivas temporales: PROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte
Anterior Uveitis

Participants with AU at entry
Intermediate Uveitis

Participants with IU at entry
Other

Participants not fitting above criteria
Posterior/Pan Uveitis

Participants with non-infectious posterior or pan-uveitis

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The clinical data and samples from this study will be used to test for interaction of key parameters of phenotype with genetic variants and other biomarkers identified from biospecimens.
Periodo de tiempo: 7 years

The intent is to collect data on a variety of phenotypic pararmeters and to store biospecimens in a manner that permits a broad array of potnential testing and experimentation in the future.
7 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Secondary outcomes will include the number and severity of systemic and ocular adverse events among participants who use systemic immunosuppression.
Periodo de tiempo: 7 years

Events include but are not limited to structural ocular complications, hospitalizations, osteoporosis, renal and hepatic side effects, infections and myelosuppression from conventional immunosuppressives and biologics
7 years

Colaboradores e Investigadores

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

Patrocinador

National Eye Institute (NEI)

Investigadores

  • Investigador principal: Emily Y Chew, M.D., National Eye Institute (NEI)

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

Enlaces Útiles

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 (Actual)

26 de julio de 2016

Finalización primaria (Actual)

4 de mayo de 2023

Finalización del estudio (Actual)

4 de mayo de 2023

Fechas de registro del estudio

Enviado por primera vez

13 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

13 de enero de 2016

Publicado por primera vez (Estimado)

14 de enero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

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

3 de noviembre de 2026

Última verificación

2 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 160046
  • 16-EI-0046

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Suscribir