Intravitreal Infliximab for Proliferative Vitreoretinopathy

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.

Conditions

• Rhegmatogenous Retinal Detachment
• Proliferative Vitreoretinopathy
• Retinal Detachment

Interventions

DRUG

Intravitreal infliximab

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

PROCEDURE

Pars plana vitrectomy

Standard pars plana vitrectomy

Sponsors & Collaborators

• Cairo University

  lead OTHER

Principal Investigators

• Ayman G Elnahry, MD, PhD · Cairo University

• Hany S Hamza, MD, PhD · Cairo University

• Ahmed M Younes, MD, MSc · Cairo University

• Ahmed A Abdel-Kader, MD, PhD · Cairo University

• Ahmed M Abdelbaki, MD, PhD · Cairo University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-26

Primary Completion

2023-11-10

Completion

2023-11-10

FDA Drug

Yes

Countries

• Egypt

Study Locations