Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04891991
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2021-05-10
Brief Title:
Intravitreal Infliximab for Proliferative Vitreoretinopathy
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Treatment of Proliferative Vitreoretinopathy With Intravitreal Infliximab
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
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:
FIXER
Brief 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
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
Detailed Description:
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
The incidence of PVR in all cases of retinal detachment is estimated to be 5- 10 The incidence of PVR has largely remained unchanged in prospective studies despite the evolution of vitreoretinal techniques over the past 25 years including valved trocars and smaller gauge instrumentation
Numerous risk factors for the development of PVR have been identified Almost all risk factors for PVR are associated with intravitreal dispersion of retinal pigment epithelial cells or breakdown of the blood-ocular barrier Following a retinal break the retinal pigment epithelial RPE cells are exposed to the vitreous cavity to react to growth factors and cytokines in the vitreous resulting in a forward feedback to secret more growth factors and cytokines to further stimulate cellular responses
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 RPE cells contribute to the initiation of PVR This is because TNF-α was found to act on the RPE cells consequently inducing changes in cellular morphologies leading to the formation of fibroblastic cells Additionally if TNF-α is combined with other growth factors a strong synergistic effect can be induced to form epithelial-mesenchymal transition EMT-associated fibrotic focus
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
The incidence of PVR in all cases of retinal detachment is estimated to be 5- 10 The incidence of PVR has largely remained unchanged in prospective studies despite the evolution of vitreoretinal techniques over the past 25 years including valved trocars and smaller gauge instrumentation
Numerous risk factors for the development of PVR have been identified Almost all risk factors for PVR are associated with intravitreal dispersion of retinal pigment epithelial cells or breakdown of the blood-ocular barrier Following a retinal break the retinal pigment epithelial RPE cells are exposed to the vitreous cavity to react to growth factors and cytokines in the vitreous resulting in a forward feedback to secret more growth factors and cytokines to further stimulate cellular responses
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 RPE cells contribute to the initiation of PVR This is because TNF-α was found to act on the RPE cells consequently inducing changes in cellular morphologies leading to the formation of fibroblastic cells Additionally if TNF-α is combined with other growth factors a strong synergistic effect can be induced to form epithelial-mesenchymal transition EMT-associated fibrotic focus
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 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?:
True
Is an FDA AA801 Violation?:
None