Ignite Creation Date:
2024-05-06 @ 8:51 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02834559
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2016-07-12
Brief Title:
Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment
Sponsor:
Universitätsklinikum Köln
Organization:
Universitätsklinikum Köln
Study Overview
Official Title:
Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment
Status:
COMPLETED
Status Verified Date:
2022-04
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:
PRIVENT
Brief Summary:
This study investigates the effectiveness of a simple treatment to prevent proliferative vitreoretinopathy PVR
Intraoperative intravitreal 5-fluorouracil 5-FU and low molecular weight heparin LMWH is used as a prophylactic therapy in high-risk patients with primary rhegmatogenous retinal detachment RRD Our major motivation is to reduce the incidence of PVR in the group that receives the trial drug
Intraoperative intravitreal 5-fluorouracil 5-FU and low molecular weight heparin LMWH is used as a prophylactic therapy in high-risk patients with primary rhegmatogenous retinal detachment RRD Our major motivation is to reduce the incidence of PVR in the group that receives the trial drug
Detailed Description:
Proliferative vitreoretinopathy PVR is a common cause for postoperative failure after vitreoretinal surgery for primary RRD There is no standard-therapy to prevent PVR Several attempts using chemotherapeutic agents have been undertaken to prevent this proliferation-process but none of these was introduced into routine clinical practice
Until recently it has been challenging to identify patients with high risk for postoperative PVR formation This is especially important because in this trial treatment with the trial drug will be restricted to patients at high risk for PVR only
Patients are assigned to the following treatment arms 11
A Intraoperative adjuvant application of 5-fluorouracil 5-FU and low molecular weight heparin LMWH via intraocular infusion during routine pars plana vitrectomy PPV in high-risk patients for proliferative vitreoretinopathy PVR with primary rhegmatogenous retinal detachment RRD
Versus
B Routinely used intraocular infusion with balanced salt solution BSS during routine PPV
Until recently it has been challenging to identify patients with high risk for postoperative PVR formation This is especially important because in this trial treatment with the trial drug will be restricted to patients at high risk for PVR only
Patients are assigned to the following treatment arms 11
A Intraoperative adjuvant application of 5-fluorouracil 5-FU and low molecular weight heparin LMWH via intraocular infusion during routine pars plana vitrectomy PPV in high-risk patients for proliferative vitreoretinopathy PVR with primary rhegmatogenous retinal detachment RRD
Versus
B Routinely used intraocular infusion with balanced salt solution BSS during routine PPV
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 |
|---|---|---|---|
| 2015-004731-12 | EUDRACT_NUMBER | None | None |