National Eye Institute Biorepository for Retinal Diseases
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Ocular, Diabetes |
| Therapuetic Areas: | Endocrinology, Ophthalmology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/13/2019 |
| Start Date: | December 1, 2011 |
| Contact: | Faith Chen |
| Email: | chenfa@nei.nih.gov |
| Phone: | (301) 402-1369 |
NEI Intramural Biorepository for Retinal Diseases
Background:
- To understand diseases of the retina and the eye, information is needed about people with
and without such diseases. Researchers want to study these people and follow them over time.
They also want to study body tissues and blood to understand the nature of eye disease.
Studying genes, cells, and tissues may help them understand why some people get eye problems
and others do not, or why some people respond to treatment while others do not. Researchers
want to collect physical samples and personal data to develop a National Eye Institute
database.
Objectives:
- To collect health information and blood and tissue samples from people with and without eye
diseases, to be used in research studies.
Eligibility:
- Individuals of any age with different types of eye disease.
- Healthy volunteers with no history of eye disease.
Design:
- Participants may be recruited from National Eye Institute studies or may be referred
from other sources.
- Participants will be screened with a physical exam and medical history. They will also
have a full eye exam. Questions will be asked about family medical history, especially
about eye disease.
- Blood samples will be collected. Other samples, such as saliva, tears, hair, stool, and
urine, may be collected as needed. Adult participants may also provide a skin sample.
- Tissue or fluid from eye collected as part of eye care or treatment may also be added to
the database.
- No treatment will be provided as part of this study.
- To understand diseases of the retina and the eye, information is needed about people with
and without such diseases. Researchers want to study these people and follow them over time.
They also want to study body tissues and blood to understand the nature of eye disease.
Studying genes, cells, and tissues may help them understand why some people get eye problems
and others do not, or why some people respond to treatment while others do not. Researchers
want to collect physical samples and personal data to develop a National Eye Institute
database.
Objectives:
- To collect health information and blood and tissue samples from people with and without eye
diseases, to be used in research studies.
Eligibility:
- Individuals of any age with different types of eye disease.
- Healthy volunteers with no history of eye disease.
Design:
- Participants may be recruited from National Eye Institute studies or may be referred
from other sources.
- Participants will be screened with a physical exam and medical history. They will also
have a full eye exam. Questions will be asked about family medical history, especially
about eye disease.
- Blood samples will be collected. Other samples, such as saliva, tears, hair, stool, and
urine, may be collected as needed. Adult participants may also provide a skin sample.
- Tissue or fluid from eye collected as part of eye care or treatment may also be added to
the database.
- No treatment will be provided as part of this study.
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
variety of retinal conditions, particularly age-related macular degeneration and diabetic
retinopathy, and their associated systemic correlates of disease.
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 conditions of the retina and their associated systemic correlates of
disease.
Study Population: We plan to accrue 500 participants with age-related macular degeneration
(AMD), 300 participants with diabetic retinopathy, up to 1,000 participants with other
retinal diseases, and 500 participants without any retinal disease.
Design: This is a prospective observational study of multiple retinal diseases and suitable
controls incorporating:
1. Standard of care management of eye diseases with a standardized follow-up and testing
schedule; and
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 phenotype
(such as visual acuity and retinal features on ocular imaging) with genetic variants and
other biomarkers identified from biospecimens, and the characterization of new experimental
models of eye health and disease.
of novel factors relevant to the pathogenesis, progression, and response to treatment of a
variety of retinal conditions, particularly age-related macular degeneration and diabetic
retinopathy, and their associated systemic correlates of disease.
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 conditions of the retina and their associated systemic correlates of
disease.
Study Population: We plan to accrue 500 participants with age-related macular degeneration
(AMD), 300 participants with diabetic retinopathy, up to 1,000 participants with other
retinal diseases, and 500 participants without any retinal disease.
Design: This is a prospective observational study of multiple retinal diseases and suitable
controls incorporating:
1. Standard of care management of eye diseases with a standardized follow-up and testing
schedule; and
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 phenotype
(such as visual acuity and retinal features on ocular imaging) with genetic variants and
other biomarkers identified from biospecimens, and the characterization of new experimental
models of eye health and disease.
- INCLUSION CRITERIA:
Participants will be eligible if they:
1. Have the ability to understand and sign an informed consent or have a parent/legal
guardian to do so if they are minor children.
2. Manifest diagnosed or undiagnosed retinal disease or could serve as an unaffected
control suitable for comparison to participants with various retinal disease,
particularly AMD and diabetic retinopathy (taking into account matching factors such
as age and past ocular history).
EXCLUSION CRITERIA:
Participants will not be eligible if they:
1. Are unable or unwilling to give informed consent that includes collection and study of
at least one peripheral blood sample.
2. Are unable or unwilling to give informed consent that includes use of NIH medical
records and clinical samples for research related to vision and diseases affecting the
eyes.
3. Are unable or unwilling to be managed as clinically indicated.
4. Have a systemic disease that compromises the ability to provide adequate
ophthalmologic examination or treatment.
The eligibility requirements for this protocol are intended to be broadly inclusive, but
those individuals found to be ineligible may be evaluated under the NEI Screening Protocol
(08-EI-0102) for potential participation in other studies. Adults unable to understand and
sign an informed consent are excluded from this study because they are frequently unable to
cooperate with evaluation and testing in the manner standardized for other adult
participants.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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