Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347698
Status:
WITHDRAWN
Last Update Posted:
2024-05-30
First Post:
2006-06-30
Brief Title:
Intravitreal Bevacizumab vs Photocoagulation for Proliferative Diabetic Retinopathy
Sponsor:
Asociación para Evitar la Ceguera en México
Organization:
Asociación para Evitar la Ceguera en México
Study Overview
Official Title:
Intravitreal Bevacizumab vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy A One-year Prospective Contralateral Eye Study
Status:
WITHDRAWN
Status Verified Date:
2024-05
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Undefined
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the safety and efficacy of 25 mg of intravitreal bevacizumab in one eye versus panretinal photocoagulation in the contralateral eye for the treatment of patients with untreated symmetric proliferative diabetic retinopathy
Detailed Description:
The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation However it is a treatment that results in significant discomfort to the patient causes reduction of visual acuity and visual field impairment Intravitreal bevacizumab is a novel treatment that reduces intraocular VEGF concentration and therefore inhibits neovascular proliferation without causing significant disconfort to the patient nor affecting visual acuity or visual fields although with other risks associated with intravitreal injection Making a comparison between both treatments in different patients is difficult because there are other variables that influence the progression of the disease such as glycemic control or renal insufficiency Therefore this study is designed using both treatments in the same patient intravitreal bevacizumab in one eye compared to panretinal photocoagulation in the contralateral eye and evaluating visual acuity visual fields fluorescein angiography optic coherence tomography of the macula and patient discomfort in a one-year follow-up
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