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ブドウ膜炎/眼内炎症性疾患バイオバンク (iBank)

2026年11月3日 更新者：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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

343

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Maryland
      • Bethesda、Maryland、アメリカ、20892
        • National Institutes of Health Clinical Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

8年～100年 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

  • 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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：COHORT
  • 時間の展望：PROSPECTIVE

コホートと介入

グループ/コホート
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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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.
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Secondary outcomes will include the number and severity of systemic and ocular adverse events among participants who use systemic immunosuppression.
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

National Eye Institute (NEI)

捜査官

  • 主任研究者：Emily Y Chew, M.D.、National Eye Institute (NEI)

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年7月26日

一次修了 (実際)

2023年5月4日

研究の完了 (実際)

2023年5月4日

試験登録日

最初に提出

2016年1月13日

QC基準を満たした最初の提出物

2016年1月13日

最初の投稿 (推定)

2016年1月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月4日

QC基準を満たした最後の更新が送信されました

2026年11月3日

最終確認日

2026年11月2日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 160046
  • 16-EI-0046

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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