Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-28 @ 1:21 PM
Study NCT ID:
NCT00831350
Status:
COMPLETED
Last Update Posted:
2017-10-30
First Post:
2009-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posterior Vitreous Detachment (PVD) Assessment During Dual Retinal Vein Occlusion (RVO) Lucentis Evaluations
Sponsor:
Barnes Retina Institute
Organization:
Study Overview
Official Title:
Posterior Vitreous Detachment (PVD) Assessment During Dual RVO Lucentis Evaluations (PADDLE Study)
Status:
COMPLETED
Status Verified Date:
2017-10
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:
PADDLE
Brief Summary:
This is a study of subjects with retinal vein occlusion (RVO) specifically looking at the difference in outcomes between patients with posterior vitreous detachment (PVD) and those without PVD. Posterior vitreous detachment is a condition where the gel-like substance that occupies the space between the retina and the lens of the eye liquefies and separates from the retina. 20 subjects from Barnes Retina Institute will be enrolled in this study. Based on a pre-treatment ultrasound (a test utilizing high-frequency sound waves to look at the inside of the eye), high resolution OCT (a noninvasive procedure called optical coherence tomography to check the thickness of your retina) and clinical exam, subjects will be assigned to one of 2 groups at baseline: Group 1 will be those with PVD and Group 2 will be those without PVD. Then subjects will receive monthly intravitreal (inside the eye) injections of Ranibizumab.
Detailed Description:
Several retinovascular diseases have been shown to be VEGF dependent including retinal vein occlusion, wet age-related macular degeneration, and diabetic retinopathy. The role of the vitreous or composition of the vitreous cavity has been examined in diabetic retinopathy on many occasions in the past and clinically it has been felt that a posterior vitreous separation leads a quieting and involution of diabetic retinopathy, both proliferative as well as pre-proliferative retinopathy. This clinical observation has never had any basic science data to support it. However, it has recently been shown that in cat eyes with posterior vitreous separation the vitreous cavity has a much lower VEGF concentration than in cat eyes with an attached posterior vitreous. This may be due to the fact that flow of oxygen from the retinal vasculature is increased by PVD. Vitreous oxygen levels are inversely associated with vitreous VEGF levels. As oxygen tension increases, VEGF levels will decline. This suggests if higher amounts of VEGF are present in the eye without PVD perhaps a powerful anti-VEGF drug, such as ranibizumab, may be of greater benefit to treat VEGF dependent retinovascular disease. To try and answer this question clinically, we have suggested that an analysis of the vitreous status in treatment naive eyes with retinal vein occlusion beginning ranibizumab therapy be undertaken to see if eyes without a posterior vitreous separation would achieve greater improvement in vision and a return to more normal retinal physiology compared to eyes with a posterior vitreous separation. No study has assessed PVDs in RVO patients receiving potential treatment.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 09-0049 | None | None | View |