Intravitreal Infliximab for the Treatment of Proliferative Vitreoretinopathy (FIXER): A Randomized Controlled Phase 2 Trial

Abstract

To study the safety and efficacy of intravitreal infliximab administered at the conclusion of pars plana vitrectomy (PPV) in the treatment of proliferative vitreoretinopathy (PVR) associated with rhegmatogenous retinal detachment (RRD). Randomized controlled phase 2 clinical trial. Patients with primary RRD and Grade C PVR, according to the updated Retina Society Classification. Sixty-six Patients were randomized in a 1:1 ratio to undergo PPV and silicone oil (SO) injection with or without intravitreal injection of 1 mg/0.05 mL of infliximab in the air-filled globe before SO injection at PPV conclusion. Surgeons were masked to treatment allocation until PPV conclusion. The primary outcome measure was anatomic success (defined as complete retinal reattachment without a tamponade at 6 months post SO removal). Secondary outcome measures were final best corrected visual acuity (BCVA), single operation success rate (SOSR), rate of recurrent detachment, central macular thickness (CMT) by macular optical coherence tomography (OCT), macular function by multifocal electroretinogram and macular vascular density (VD) by OCT angiography. 60 eyes of 60 patients, 30 eyes in each group, completed the study. At baseline, there were no differences regarding age, gender, history of trauma, lens status, duration of RRD, BCVA, intraocular pressure (IOP), intra-ocular inflammation (IOI), detachment extent in clock hours, number/size of breaks, presence of vitreous hemorrhage, axial length, or grade/extent of PVR between both groups. For the outcome measures, 30 eyes in the infliximab group achieved anatomic success vs 29 eyes in the control group. The SOSR was higher in the infliximab group (26) vs the control (23), but this was not statistically significant (p = 0.317). Final BCVA was better in the infliximab group (mean logMAR (SD) = 0.96 (0.4), Snellen equivalent ≈ 20/180) vs the control (1.14 (0.4), Snellen equivalent ≈ 20/280) (p = 0.044). There were no differences regarding IOP, IOI, time of SO removal, macular function, CMT, or VD. PPV with SO tamponade with or without intravitreal infliximab is effective in treating PVR-associated RRD. Infliximab may be associated with modest improvement in final visual outcomes but not anatomical outcomes.