Advertisement

Topics

Comparison of Interval Variation and Dosage in Preoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy

2015-10-28 14:38:22 | BioPortfolio

Summary

Proliferative diabetic retinopathy patients requiring pars plana vitrectomy receiving preoperative 0.625 mg intravitreal bevacizumab 3-10 days prior to vitrectomy will have similar surgery times and similar intra-operative and postoperative complications to subjects who receive preoperative 1.25 mg intravitreal bevacizumab at both 3-5 days, and 6-10 days prior to vitrectomy.

Description

Severe vision loss in patients with proliferative diabetic retinopathy (PDR) frequently results from complications related to neovascularization and fibrovascular proliferation. Patients with PDR are typically considered candidates for pars plana vitrectomy (PPV) when non-clearing vitreous hemorrhaging, tractional retinal detachment (TRD) development or extensive fibrovascular proliferation occur. Visual prognosis is guarded in patients undergoing PPV with these advanced presentations of PDR because of the high rate of both intra-operative and postoperative complications. Intra-operative bleeding may result in poor visualization during PPV that increases total surgery time and ultimately leads to surgical failure, while recurrent/persistent postoperative vitreous hemorrhage may occur as high as 75% and hinder visual rehabilitation and monitoring of further disease progression.

Preoperative administration of bevacizumab (Avastin; Genentech, Inc, South San Francisco, California, USA), a full-length recombinant humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF), has been reported in prospective clinical trials to decrease the overall surgery time, lower the rate of intra-operative complications, and reduce the occurrence of postoperative hemorrhaging in PDR patients with active neovascularization and/or extensive fibrovascular proliferation undergoing PPV. Furthermore, two meta-analysis studies examining published randomized controlled trials support the use of intravitreal bevacizumab (IVB) as a preoperative adjunct. Although IVB is widely used as a preoperative adjunct in patients with PDR undergoing PPV, little clinical data is available regarding the optimal timing of preoperative IVB administration or the most effective dose. In this randomized prospective study, we attempt to elucidate the most appropriate interval and dose for the administration of preoperative IVB in patients with PDR undergoing PPV for non-clearing vitreous hemorrhaging, TRD or extensive fibrovascular proliferation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Conditions

Proliferative Diabetic Retinopathy, Pars Plana Vitrectomy, Intravitreal Bevacizumab

Intervention

Intravitreal bevacizumab

Location

Hospital La Carlota
Montemorelos
Nuevo Leon
Mexico

Status

Recruiting

Source

Panhandle Eye Group, LLP

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-10-28T14:38:22-0400

Clinical Trials [2559 Associated Clinical Trials listed on BioPortfolio]

Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)

The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with an...

Intravitreal Injection of Ranibizumab Versus Sham Before Vitrectomy in Patients With Proliferative Diabetic Retinopathy

Certain percent of the eyes with proliferative diabetic retinopathymay require pars plana vitrectomy (PPV) due to vitreous haemorrhage, proliferative membrane, and tractional retinal detac...

Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage

Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. There have been efforts to lower the incidence of postoperative vitreous...

Severe Proliferative Diabetic Retinopathy

The purpose of this study is to examine and compare, prospectively, best corrected visual acuity (BCVA) outcomes and complications of a cohort of patients with Proliferative Diabetic Retin...

Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

Recently, intravitreal bevacizumab (Avastin) injection has gained popularity as a potential treatment of intraocular neovascularization (CNV) associated with age related macular degenerati...

PubMed Articles [2499 Associated PubMed Articles listed on BioPortfolio]

Preoperative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy: Prospective Randomized Clinical Trial of the Pan-American Collaborative Retina Study (PACORES) Group.

To assess the effectiveness and safety of an intravitreal injection of 1.25 mg of bevacizumab (IVB) as a preoperative adjunct to small-gauge pars plana vitrectomy (PPV) compared to PPV alone in eyes w...

Pars plana vitrectomy.

Pars plana vitrectomy (PPV) allows the treatment of a multitude of vitreoretinal disorders involving the vitreous, the retina or the choroid. There is a multitude of possible surgical sequences: peeli...

Treatment of Macular Edema after Pars Plana Vitrectomy for Idiopathic Epiretinal Membrane Using Intravitreal Dexamethasone Implant: Long-Term Outcomes.

The aim of this study was to investigate the efficacy and safety of intravitreal dexamethasone implant for the treatment of macular edema after pars plana vitrectomy (PPV) for epiretinal membrane (ERM...

Intravitreal neurodegenerative and inflammatory mediators in proliferative diabetic retinopathy.

To compare the intravitreal concentrations of cellular mediators involved in neurodegeneration, inflammation, and angiogenesis in patients with proliferative diabetic retinopathy and other vitreoretin...

Conbercept and Ranibizumab Pretreatments in Vitrectomy with Silicone Oil Infusion for Severe Diabetic Retinopathy.

We compared the efficacies of intravitreal ranibizumab (IVR) and intravitreal conbercept (IVC) as the adjuvant pretreatments for vitrectomy with silicone oil infusion for tractional retinal detachment...

Medical and Biotech [MESH] Definitions

Removal of the whole or part of the vitreous body in treating endophthalmitis, diabetic retinopathy, retinal detachment, intraocular foreign bodies, and some types of glaucoma.

Form of granulomatous uveitis occurring in the region of the pars plana. This disorder is a common condition with no detectable focal pathology. It causes fibrovascular proliferation at the inferior ora serrata.

Inflammation of the pars plana, ciliary body, and adjacent structures.

A drug used to reduce hemorrhage in diabetic retinopathy.

Disease of the RETINA as a complication of DIABETES MELLITUS. It is characterized by the progressive microvascular complications, such as ANEURYSM, interretinal EDEMA, and intraocular PATHOLOGIC NEOVASCULARIZATION.

More From BioPortfolio on "Comparison of Interval Variation and Dosage in Preoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Diabetes
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...


Searches Linking to this Trial