NCT00001733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
8.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2008

Completed
Last Updated

July 2, 2017

Status Verified

July 2, 2008

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Diabetic RetinopathyMacular DegenerationPathologic NeovascularizationRetinal Disease

Keywords

Diabetic RetinopathyAge-Related Macular DegenerationNeovascularizationMacular DegenerationRetinal DiseaseDiabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • All studies of retinovascular diseases require the subject to have minimum age of 18 years in both men and women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Diabetic RetinopathyMacular DegenerationNeovascularization, PathologicRetinal DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Eye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsEndocrine System DiseasesRetinal DegenerationMetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

March 6, 1998

Study Completion

July 2, 2008

Last Updated

July 2, 2017

Record last verified: 2008-07-02

Locations

US(1)