Screening for Studies on Retinovascular Diseases
Primary Purpose
Diabetic Retinopathy, Macular Degeneration, Pathologic Neovascularization
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Diabetic Retinopathy focused on measuring Diabetic Retinopathy, Age-Related Macular Degeneration, Neovascularization, Macular Degeneration, Retinal Disease, Diabetes
Eligibility Criteria
INCLUSION/EXCLUSION CRITERIA Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. In addition to those diagnoses currently under study, subjects with unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study. All studies of retinovascular diseases require the subject to have minimum age of 18 years in both men and women.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001733
First Posted
November 3, 1999
Last Updated
June 30, 2017
Sponsor
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT00001733
Brief Title
Screening for Studies on Retinovascular Diseases
Official Title
Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Retinovascular Diseases
Study Type
Observational
2. Study Status
Record Verification Date
July 2, 2008
Overall Recruitment Status
Completed
Study Start Date
March 6, 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2, 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Eye Institute (NEI)
4. Oversight
5. Study Description
Brief Summary
This screening protocol is designed to help recruit patients for National Eye Institute (NEI) studies of the retina, such as diabetic retinopathy and macular degeneration. Patients must meet the specific criteria of a research study, and this protocol serves as a first step for admitting patients to a retinal disease study.
Candidates will undergo a medical history and comprehensive eye examination. The eye examination includes dilation of the pupils to fully examine the retina. In some studies, photographs of the eye are required. This is done using fluorescein angiography. In this procedure, a dye called sodium fluorescein is injected into the blood stream through a vein. After the dye reaches the blood vessels of the eye, photographs are taken of the retina. Other diagnostic procedures may include physical examination, questionnaires, routine laboratory tests and other standard or specialized tests, as needed.
When the screening is completed, patients will be informed of their options to participate in a study. Patients who are ineligible for a current study will be informed of alternative treatments or options. No treatment is offered under this protocol.
Detailed Description
This protocol is designed for the screening of patients with presumed retinovascular diseases. It serves as a first step for individuals who may be eligible and wish to participate in National Eye Institute clinical research studies of retinovascular diseases.
Each individual will be thoroughly evaluated during the screening process to determine if they are suitable candidates for inclusion in any of the National Eye Institute ongoing studies. The screening evaluation will include past and current medical histories and an appropriate physical examination, namely a comprehensive eye exam. Other routine diagnostic procedures and tests may also be completed in order to help determine a subject's eligibility. These tests and procedures are of minimal risk and will be described in more detail in section III: "Study Procedures." Once the screening process is completed and their eligibility is assessed, the subjects will be informed of their options to participate in one or more of the current clinical research studies. If no appropriate protocol is identified, recommendations for other treatment options may be given to the individual, their primary doctor, or referring physician.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Macular Degeneration, Pathologic Neovascularization, Retinal Disease
Keywords
Diabetic Retinopathy, Age-Related Macular Degeneration, Neovascularization, Macular Degeneration, Retinal Disease, Diabetes
7. Study Design
Enrollment
2000 (false)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION/EXCLUSION CRITERIA
Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened.
In addition to those diagnoses currently under study, subjects with unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study.
All studies of retinovascular diseases require the subject to have minimum age of 18 years in both men and women.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
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Screening for Studies on Retinovascular Diseases
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