CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Intravitreal infliximab +1 moredrug
Likely dose
Intravitreal infliximab 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04891991
NCT04891991Phase 2Completed

Treatment of Proliferative Vitreoretinopathy With Intravitreal Infliximab

Cairo University·interventional·Posted May 19, 2021·Updated Jan 19, 2024

In Brief

A Phase 2 clinical trial evaluating Intravitreal infliximab and Pars plana vitrectomy for Rhegmatogenous Retinal Detachment and 2 related conditions. Completed, enrolled 66 participants across 1 site.

Detailed Summary

Proliferative vitreoretinopathy (PVR) is the most common cause for failure of rhegmatogenous retinal detachment repair and is characterized by the growth and contraction of cellular membranes within the vitreous cavity on both sides of the retinal surface as well as intraretinal fibrosis. Multiple therapeutic agents have been tried as an adjunctive to retinal detachment surgery for PVR with no consistent efficacy. Tumor necrosis factor-α (TNF-α), which is a prominent inflammatory cytokine, is secreted in response to trauma, infection, and inflammation. It is a key mediator of ocular inflammation and its interactions with the retinal pigment epithelium (RPE) cell contribute to the initiation of PVR. This may occur through the action of TNF-α on the RPE cells inducing changes in cellular morphologies that lead to the formation of fibroblastic cells. Infliximab (Remicade; Janssen Biotech, Horsham, PA, USA) is a mouse-human chimeric antibody that neutralizes the biological activity of TNF-α by high-affinity binding to the soluble and transmembrane forms of TNF-α, therefore preventing the effective binding of TNF-α with its receptors. Infliximab is used in the treatment of various ocular and systemic inflammatory conditions. Furthermore, intravitreal infliximab has been used for the treatment of various ocular diseases and has proven to be generally safe for the short term in inflammatory ocular conditions. A recent study showed that intravitreal infliximab can inhibit the development of PVR and reduce levels of cytokines in an experimental dispase-induced PVR model. The purpose of this randomized controlled trial is to evaluate the efficacy of intravitreal infliximab injection as an adjunct to pars plana vitrectomy in the treatment of PVR associated with primary rhegmatogenous retinal detachment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedMay 19, 2021
Enrollment StartNov 26, 2021
Primary CompletionNov 10, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.1 years ago

Interventions

Intravitreal infliximabdrug

1 mg/0.05 mL of infliximab will be injected intravitreally at the end of pars plana vitrectomy.

Pars plana vitrectomyprocedure

Standard pars plana vitrectomy