Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021645
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-07-26
Brief Title:
Vitamin E to Treat Uveitis-Associated Macular Edema
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Randomized Masked Study to Evaluate the Use of Vitamin E in the Treatment of Uveitis-Associated Macular Edema
Status:
COMPLETED
Status Verified Date:
2004-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate whether vitamin E can help treat swelling of the macular area of the retina the back part of the eye associated with uveitis inflammatory eye disease The macula is responsible for sharp vision swelling in this area is one cause of vision loss in uveitis patients Macular swelling is also associated with eye problems related to diabetes In these patients the swelling is thought to be caused by a substance called vascular endothelial growth factor or VEGF High doses of vitamin E have been used to treat these eye problems in diabetics This study is a first step to find out if vitamin E will help reduce the retinal swelling in uveitis which may also be caused by VEGF
Patients 9 years of age and older with macular edema associated with uveitis may be eligible for this study Candidates will be screened with the following tests and procedures
Medical history and physical examination This includes measurement of vital signs blood pressure pulse temperature and breathing rate and examination of the head and neck heart lungs abdomen arms and legs
Eye examination This includes measurement of visual acuity using a vision chart measurement of eye pressure and examination of the pupils and eye movements The pupils will be dilated with drops to permit examination of the back of the eye
Fluorescein angiography This test uses a yellow dye fluorescein to take photos of the retina The fluorescein is injected into an arm vein and travels to the blood vessels in the eye The camera flashes a blue light into the eye and takes pictures of the retina The pictures show if the dye has leaked from the blood vessels into the retina
Stereoscopic color fundus photography These are photographs of the back of the eye taken after the pupils have been dilated with drops
Optical coherence tomography This test measures the macular swelling It is used to determine if the swelling is getting worse better or staying the same
Blood tests About a tablespoon of blood is drawn to measure inflammation and cell counts and side effects of treatment
Pregnancy test All women of child-bearing potential are tested for pregnancy
Participants will be randomly assigned to daily treatment with oral high-dose vitamin E 1600 units or placebo a pill with no active ingredient for 4 months They will be examined at 2 months and 4 months with the same tests performed for screening and will return for a final clinic visit 1 month after treatment has ended
Patients 9 years of age and older with macular edema associated with uveitis may be eligible for this study Candidates will be screened with the following tests and procedures
Medical history and physical examination This includes measurement of vital signs blood pressure pulse temperature and breathing rate and examination of the head and neck heart lungs abdomen arms and legs
Eye examination This includes measurement of visual acuity using a vision chart measurement of eye pressure and examination of the pupils and eye movements The pupils will be dilated with drops to permit examination of the back of the eye
Fluorescein angiography This test uses a yellow dye fluorescein to take photos of the retina The fluorescein is injected into an arm vein and travels to the blood vessels in the eye The camera flashes a blue light into the eye and takes pictures of the retina The pictures show if the dye has leaked from the blood vessels into the retina
Stereoscopic color fundus photography These are photographs of the back of the eye taken after the pupils have been dilated with drops
Optical coherence tomography This test measures the macular swelling It is used to determine if the swelling is getting worse better or staying the same
Blood tests About a tablespoon of blood is drawn to measure inflammation and cell counts and side effects of treatment
Pregnancy test All women of child-bearing potential are tested for pregnancy
Participants will be randomly assigned to daily treatment with oral high-dose vitamin E 1600 units or placebo a pill with no active ingredient for 4 months They will be examined at 2 months and 4 months with the same tests performed for screening and will return for a final clinic visit 1 month after treatment has ended
Detailed Description:
We plan to test the efficacy of alpha-tocopherol vitamin E a potent inhibitor of the protein kinase C pathway in vascular endothelial growth factor VEGF induced vascular permeability for the treatment of uveitis-associated macular edema This will be performed using a double-masked randomized study in which uveitis patients with macular edema will receive either alpha-tocopherol or placebo This study should be considered a pilot study that will provide information on design and outcome measurement for the development of a larger definitive future study Patients will receive 1600IUday of Vitamin E or placebo for 4 months The primary outcome will be a visual acuity increase of 10 letters or more from baseline to month 4 Secondary outcomes are total area of leakage and macular height as determined by fluorescein angiography changes in CME as measured by stereoscopic color photographs optical coherence tomography OCT the need for periocular injections or additional systemic immunomodulatory medications and the NEI VFQ summary score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-EI-0214 | None | None | None |