Advertisement

Topics

Use of Pan-Vascular Endothelial Growth Factor Receptor (Pan-VEGF) Blockade for the Treatment of Retinopathy of Prematurity (ROP) (Compassionate Use BLOCK-ROP)

2014-08-27 03:23:18 | BioPortfolio

Summary

The purpose of this study is to provide access to intravitreal injection of Avastin in high-risk infants who do not otherwise qualify for study NCT00702819, an investigational multi-site study examining Avastin use for retinopathy of prematurity.

Description

Retinopathy of Prematurity (ROP) is a leading cause of blindness in children in developed countries around the world, and an increasing cause of blindness in developing countries. The retina lines the inside of the eye. It functions as "film" within the camera which is the eye. When an infant is born prematurely, the vascular network necessary to nourish the retina has not fully developed. As a consequence, in some infants abnormal vessels proliferate instead of the normal ones - a condition known as ROP. The abnormal vessels carry scar tissue along with them, and may lead to retinal detachment and blindness if the eye is not treated. The Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) Study demonstrated that ablation of the peripheral avascular retina reduced the risk of poor structural and visual outcome due to retinal distortion or detachment in ROP (1980's). The ablated retina is not functional and is not amenable to regeneration. Peripheral retinal ablation is not universally effective in fostering regression of ROP. This is particularly true for an aggressive form of ROP (aggressive posterior ROP, or APROP) which typically afflicts profoundly premature and infirm neonates. In this subset of infants, progression of ROP to bilateral retinal detachment and blindness occurs despite timely and complete peripheral retinal laser ablation.

The development of ROP is largely dependent on vascular endothelial growth factor (VEGF). When an infant is born prematurely the relatively hyperoxic environment the baby is introduced to shuts down the production of VEGF. Retinal maturation is delayed. Subsequently, at a time when intraocular VEGF levels would normally be declining late in the third trimester of pregnancy, abnormally high levels of VEGF are seen due to large areas of avascular retina and associated tissue hypoxia. The availability of FDA-approved drugs for anti-VEGF treatment renders it possible to treat such eyes off-label. Available drugs include pegaptanib sodium (Macugen) for partial blockage of VEGF-A, or drugs such as ranibizumab (Lucentis) and bevacizumab (Avastin), which cause complete blockage of VEGF-A. As VEGF is required in the developing retina for normal angiogenesis, our goal is not to penetrate tissue, but to block the excessive levels of VEGF trapped within the overlying vitreous which is responsible for the abnormal vasculature in ROP.

For purposes of this study we have chosen bevacizumab (Avastin), which will: a) attain complete blockage (vs. Macugen) of intravitreal VEGF-A, and; b) which is limited in its ability to penetrate tissues because it is a full antibody (vs. Lucentis, an antibody fragment specifically designed for better tissue penetration), and is more likely to restore VEGF homeostasis within the developing retina.

There is a nearly identical multi-site trial (NCT00702819) currently recruiting, which Childrens Hospital Los Angeles is a part of. However, that study has limiting enrollment criteria; this compassionate-use study was created to provide access to bevacizumab (Avastin) for high-risk infants who do not qualify for study NCT00702819.

Study Design

N/A

Conditions

Retinopathy of Prematurity

Intervention

Bevacizumab (Avastin)

Location

Childrens Hospital Los Angeles
Los Angeles
California
United States
90027

Status

Temporarily not available

Source

Children's Hospital Los Angeles

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:23:18-0400

Clinical Trials [1417 Associated Clinical Trials listed on BioPortfolio]

Bevacizumab Eliminates the Angiogenic Threat of Retinopathy of Prematurity

This study will determine whether injections into the vitreous of an anti-vascular endothelial growth factor (VEGF) will reduce the incidence of blindness by suppressing the neovascular ph...

Refractive Error and Biometry in Retinopathy of Prematurity

The investigators compared long-term refractive and biometric outcomes in children with retinopathy of prematurity who received two different anti-vascular endothelial growth factor agents...

Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

Purpose:Retinopathy of prematurity (ROP) continues tobe a major cause of blindness in children. Although ablation of the retina with laser or cryotherapy reduces the incidence of blindness...

A Phase II Safety and Tolerability Study of Bevacizumab When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain

Our hypothesis is that this study design, in which bevacizumab is added to one of six single agent chemotherapies with proven activity in metastatic breast cancer, will result in regressio...

Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.

The retinopathy of prematurity (ROP) is a public health problem, the main causes of ROP are prematurity, use of oxygen, malnutrition and oxidative stress. Vitamin E was used beforehand how...

PubMed Articles [501 Associated PubMed Articles listed on BioPortfolio]

Short-term intraocular pressure changes after intravitreal injection of bevacizumab for retinopathy of prematurity.

To evaluate the short-term changes in intraocular pressure (IOP) after intravitreal injection of bevacizumab (IVB) in premature infants with retinopathy of prematurity (ROP).

Bilateral Vitreous Hemorrhage Following Bilateral Intravitreal Injections of Bevacizumab in an Infant With Retinopathy of Prematurity.

Since the publication of BEAT-ROP in 2011, intravitreal bevacizumab (IVB) has become increasingly common for the treatment of posterior type 1 retinopathy of prematurity (ROP). However, long-term data...

Neurodevelopmental Outcomes Following Intravitreal Bevacizumab Therapy for Retinopathy of Prematurity: a prospective, case-control study.

To evaluate the neurodevelopmental and ocular developmental outcomes in premature children who have undergone intravitreal bevacizumab injection (IVB) for treatment of type 1 retinopathy of prematurit...

Retrospective Validation of the Postnatal Growth and Retinopathy of Prematurity (G-ROP) Criteria in a Japanese Cohort.

We aimed to externally validate the performance of new screening criteria for retinopathy of prematurity (ROP) developed in the Postnatal Growth and Retinopathy of Prematurity (G-ROP) study among a Ja...

AVAiLABLE NIS - AVASTIN® in lung cancer treatment in routine oncology practice in Germany.

Bevacizumab (Avastin®), a recombinant humanized monoclonal antibody, in combination with platinum-doublet chemotherapy has become a routine treatment for advanced non-small-cell lung cancer (NSCLC). ...

Medical and Biotech [MESH] Definitions

A bilateral retinopathy occurring in premature infants treated with excessively high concentrations of oxygen, characterized by vascular dilatation, proliferation, and tortuosity, edema, and retinal detachment, with ultimate conversion of the retina into a fibrous mass that can be seen as a dense retrolental membrane. Usually growth of the eye is arrested and may result in microophthalmia, and blindness may occur. (Dorland, 27th ed)

An anti-VEGF recombinant monoclonal antibody consisting of humanized murine antibody. It inhibits VEGF receptors and prevents the proliferation of blood vessels.

Monitoring of fetal heart frequency before birth in order to assess impending prematurity in relation to the pattern or intensity of antepartum UTERINE CONTRACTION.

Degenerative changes to the RETINA due to HYPERTENSION.

A drug used to reduce hemorrhage in diabetic retinopathy.

More From BioPortfolio on "Use of Pan-Vascular Endothelial Growth Factor Receptor (Pan-VEGF) Blockade for the Treatment of Retinopathy of Prematurity (ROP) (Compassionate Use BLOCK-ROP)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Blood
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...


Searches Linking to this Trial