Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04580147
Status:
UNKNOWN
Last Update Posted:
2022-05-03
First Post:
2020-09-16
Brief Title:
Intravitreal Aflibercept for the Prevention of Proliferative Vitreoretinopathy Following Retinal Detachment Repair
Sponsor:
M Ali Khan MD
Organization:
Wills Eye
Study Overview
Official Title:
A Multi-Center Randomized Sham-Controlled Phase II Trial Evaluating Intravitreal Aflibercept for the Prevention of Proliferative Vitreoretinopathy Following Macula Off Rhegmatogenous Retinal Detachment Repair The PREVENT-PVR Trial
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
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:
PREVENT-PVR
Brief Summary:
The primary objective of the study is to determine if serial intravitreal aflibercept injections IAI improve the single surgery anatomic success rate following surgical repair of primary macula involving rhegmatogenous retinal detachment RRD deemed at high risk for proliferative vitreoretinopathy PVR Preclinical work has revealed that competitive inhibition of platelet derived growth factor PDGF by vascular endothelial growth factor VEGF potentiates a pathologic sustained activation of PDGF receptors that is critical to the progression of experimental PVR VEGF blockade would mitigate this pathologic activation
Detailed Description:
The objective of this study is to determine if serial intravitreal aflibercept injections IAI improve single surgery anatomic success rate and reduce development of clinically apparent proliferative vitreoretinopathy PVR following surgical repair of primary macula involving rhegmatogenous retinal detachment RRD
This will be a randomized clinical trial with participant enrollment lasting 120 days 150 eyes will be randomized 11 to intervention serial IAI versus sham control standard of care Adult eyes with macula involving primary RRD deemed at high risk for PVR development as determined by pre-specified clinical features are eligible for enrollment
The study Aflibercept group will receive intravitreal aflibercept injection 2mg005mL at the conclusion of RRD repair surgery at post-operative day 30 plusminus 7 days and at post-operative day 60 plusminus 7 days Patients enrolled in the control group will undergo a sham procedure at post-operative day 30 plusminus 7 days and at post-operative day 60 plusminus 7 days
The primary outcome will be single surgery anatomic success retinal re-attachment rate Additional outcomes will include systemic and ocular safety of IAI in setting of RRD epiretinal membrane formation presence of grade C PVR or worse post-operative complication profile OCT-measured central macular thickness change from baseline in visual acuity Snellen wearing habitual correction
All eyes will undergo pars plana vitrectomy with or without scleral buckling and gas tamponade Post-operative exams slit lamp biomicroscopy and indirect ophthalmoscopy will include the following time-points Day 30 Day 60 Day 90 Day 120 All time points will have a window of plusminus 7 days except the Day 120 visit which will be a window of plusminus 14 days
This will be a randomized clinical trial with participant enrollment lasting 120 days 150 eyes will be randomized 11 to intervention serial IAI versus sham control standard of care Adult eyes with macula involving primary RRD deemed at high risk for PVR development as determined by pre-specified clinical features are eligible for enrollment
The study Aflibercept group will receive intravitreal aflibercept injection 2mg005mL at the conclusion of RRD repair surgery at post-operative day 30 plusminus 7 days and at post-operative day 60 plusminus 7 days Patients enrolled in the control group will undergo a sham procedure at post-operative day 30 plusminus 7 days and at post-operative day 60 plusminus 7 days
The primary outcome will be single surgery anatomic success retinal re-attachment rate Additional outcomes will include systemic and ocular safety of IAI in setting of RRD epiretinal membrane formation presence of grade C PVR or worse post-operative complication profile OCT-measured central macular thickness change from baseline in visual acuity Snellen wearing habitual correction
All eyes will undergo pars plana vitrectomy with or without scleral buckling and gas tamponade Post-operative exams slit lamp biomicroscopy and indirect ophthalmoscopy will include the following time-points Day 30 Day 60 Day 90 Day 120 All time points will have a window of plusminus 7 days except the Day 120 visit which will be a window of plusminus 14 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None