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Screening for Studies on Retinovascular Diseases

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001733
First Posted: November 4, 1999
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition
Diabetic Retinopathy Macular Degeneration Pathologic Neovascularization Retinal Disease

Study Type: Observational
Official Title: Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Retinovascular Diseases

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 2000
Study Start Date: March 6, 1998
Estimated Study Completion Date: July 2, 2008
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001733


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
  More Information

ClinicalTrials.gov Identifier: NCT00001733     History of Changes
Other Study ID Numbers: 980076
98-EI-0076
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: July 2, 2017
Last Verified: July 2, 2008

Keywords provided by National Institutes of Health Clinical Center (CC):
Diabetic Retinopathy
Age-Related Macular Degeneration
Neovascularization
Macular Degeneration
Retinal Disease
Diabetes

Additional relevant MeSH terms:
Macular Degeneration
Retinal Diseases
Diabetic Retinopathy
Neovascularization, Pathologic
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Metaplasia
Pathologic Processes