Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088283
Status:
COMPLETED
Last Update Posted:
2007-01-19
First Post:
2004-07-23
Brief Title:
Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion CRVO
Sponsor:
Eyetech Pharmaceuticals
Organization:
Eyetech Pharmaceuticals
Study Overview
Official Title:
A Phase II Randomized Dose-Ranging Double-Masked Multi-Center Trial in Parallel Groups Determining Safety Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 Weeks in Patients With Recent Vision Loss Due to Macular Edema Secondary to CRVO
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Eyetech Pharmaceuticals Inc and Pfizer Inc are studying an investigational drug MacugenTM for the possible treatment of CRVO An investigational drug is one that has not been approved by the US Food and Drug Administration FDA This investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye
The purpose of this study is to compare the safety and efficacy of a Macugen injection to a pretend injection In addition the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood called pharmacokinetics or PK
This study will involve approximately 90 people People who decide to participate will have an equal chance 1 in 3 to receive one of three study injections two of which are Macugen and one of which is a pretend injection
The purpose of this study is to compare the safety and efficacy of a Macugen injection to a pretend injection In addition the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood called pharmacokinetics or PK
This study will involve approximately 90 people People who decide to participate will have an equal chance 1 in 3 to receive one of three study injections two of which are Macugen and one of which is a pretend injection
Detailed Description:
This study will consist of 3 phases a screening phase which will last up to two weeks a confirmation phase which will last one day and a randomization phase the patient will be assigned by chance to a study group in this phase which will last approximately 52 weeks
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