Vascular Endothelial Growth Factor (VEGF) in Uveitis
Primary Purpose
Macular Edema, Cystoid, Uveitis
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Macular Edema, Cystoid focused on measuring Intermediate Uveitis, Pars Planitis, Retinal Vasculature, Uveitis, Vascular Permeability, Vitreous
Eligibility Criteria
For Uveitis Patients: Evidence on ocular examination in the past or presently of intraocular inflammation, with cells and haze in the vitreous for the intermediate and posterior uveitis patients. In order to demonstrate the presence or absence of macular edema, a fluorescein angiogram will be attempted on all patients. However, if the patient is unable or not willing to undergo the test, then if two observers from the LI can substantiate independently that there is or is not evidence of cystoid edema, the patient may be included.
Sites / Locations
- National Eye Institute (NEI)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001738
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT00001738
Brief Title
Vascular Endothelial Growth Factor (VEGF) in Uveitis
Official Title
A Pilot Study to Demonstrate the Presence of Vascular Endothelial Growth Factor (VEGF) in Uveitic Cystoid Macular Edema
Study Type
Observational
2. Study Status
Record Verification Date
August 1999
Overall Recruitment Status
Completed
Study Start Date
August 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Eye Institute (NEI)
4. Oversight
5. Study Description
Brief Summary
This study will look for the presence in blood of a substance called vascular endothelial growth factor (VEGF) in patients with uveitis (eye inflammation). It will also look for this substance in eye fluid samples taken from patients with uveitis who are undergoing eye surgery.
Some patients with uveitis experience some vision loss during an inflammatory attack because of swelling (edema) in a particular area of the retina called the macula, which is involved in visual acuity. It may be that VEGF is involved in the development of macular edema.
Patients with uveitis who participate in this study will have about 10 cc (2 teaspoons) of blood drawn to be examined for VEGF. They will also undergo a procedure called fluorescein angiography to look at the blood vessels of the eye. 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.
In addition, patients with uveitis who are undergoing eye surgery will have a tissue specimen (either aqueous fluid or vitreous gel) collected for examination for the presence of VEGF.
Detailed Description
Increased intraocular and systemic levels of the angiogenic factor vascular endothelial growth factor (VEGF) is associated with new vessel growth in the eye, such as diabetic retinopathy. Recent work using immunopathologic techniques have shown that VEGF is upregulated in both experimentally induced uveitis and in uveitic eyes as well, with no evidence of neovascularization. This pilot study will evaluate the level of VEGF in the blood of uveitic patients with and without macular edema. This level will be determined also in the ocular fluid of those patients that are undergoing ocular surgery. These levels will be compared with age and sex matched controls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Cystoid, Uveitis
Keywords
Intermediate Uveitis, Pars Planitis, Retinal Vasculature, Uveitis, Vascular Permeability, Vitreous
7. Study Design
Enrollment
60 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For Uveitis Patients:
Evidence on ocular examination in the past or presently of intraocular inflammation, with cells and haze in the vitreous for the intermediate and posterior uveitis patients.
In order to demonstrate the presence or absence of macular edema, a fluorescein angiogram will be attempted on all patients. However, if the patient is unable or not willing to undergo the test, then if two observers from the LI can substantiate independently that there is or is not evidence of cystoid edema, the patient may be included.
Facility Information:
Facility Name
National Eye Institute (NEI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
1748544
Citation
Nussenblatt RB. Proctor Lecture. Experimental autoimmune uveitis: mechanisms of disease and clinical therapeutic indications. Invest Ophthalmol Vis Sci. 1991 Dec;32(13):3131-41. No abstract available.
Results Reference
background
PubMed Identifier
3684231
Citation
Nussenblatt RB, Kaufman SC, Palestine AG, Davis MD, Ferris FL 3rd. Macular thickening and visual acuity. Measurement in patients with cystoid macular edema. Ophthalmology. 1987 Sep;94(9):1134-9. doi: 10.1016/s0161-6420(87)33314-7.
Results Reference
background
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Vascular Endothelial Growth Factor (VEGF) in Uveitis
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