Proliferative Vitreoretinopathy Clinical Trial
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)
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.
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 1:1 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 (2mg/0.05mL) at the conclusion of RRD repair surgery, at post-operative day 30 (plus/minus 7 days), and at post-operative day 60 (plus/minus 7 days). Patients enrolled in the control group will undergo a sham procedure at post-operative day 30 (plus/minus 7 days) and at post-operative day 60 (plus/minus 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 plus/minus 7 days, except the Day 120 visit which will be a window of plus/minus 14 days. ;
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