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Bevacizumab Eliminates the Angiogenic Threat of Retinopathy of Prematurity

2014-08-27 03:32:43 | BioPortfolio

Summary

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 phase of retinopathy of prematurity (ROP) compared to a control group receiving conventional laser therapy. The purpose of this study is to determine the safety and efficacy of intravitreal bevacizumab in the treatment of ROP.

Description

This phase 2 study will assess the anti-neovascularization activity of intravitreal bevacizumab, as determined by regression of neovascular vessels of retinopathy of prematurity (ROP), in neonates with acute stage 3 ROP in zone I or posterior zone II with plus disease. This study will enroll confirmed cases of vision threatening ROP (between ETROP and CRYO-ROP) which have definite plus disease. This will be done because of the controversy regarding determining plus disease and the increasing concern that many infants are being treated whose ROP would spontaneously regress. Bevacizumab will be administered intravitreally using 0.625 mg (0.025 ml) injections into each eye. There is no intent to give additional doses unless there is a recurrence of vision threatening stage 3 ROP with plus disease since the disease is self limited by completion of vascularization. Clinical response and any evidence of ocular toxicities will be documented both pre- and post-injection by RetCam retinal images and by fluorescein angiography when possible (structural documentation) and at 6 and 12 months of age by electroretinograms and by visual evoked potentials when possible (functional documentation). Any evidence of systemic toxicities will be documented by appropriate clinical and laboratory tests.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Retinopathy of Prematurity

Intervention

Bevacizumab, Conventional Laser for ROP

Location

Huntington Memorial Hospital
Pasadena
California
United States
91109

Status

Recruiting

Source

The University of Texas Health Science Center, Houston

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:43-0400

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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)

A technique utilizing a laser coupled to a catheter which is used in the dilatation of occluded blood vessels. This includes laser thermal angioplasty where the laser energy heats up a metal tip, and direct laser angioplasty where the laser energy directly ablates the occlusion. One form of the latter approach uses an EXCIMER LASER which creates microscopically precise cuts without thermal injury. When laser angioplasty is performed in combination with balloon angioplasty it is called laser-assisted balloon angioplasty (ANGIOPLASTY, BALLOON, LASER-ASSISTED).

Techniques using laser energy in combination with a balloon catheter to perform angioplasty. These procedures can take several forms including: 1, laser fiber delivering the energy while the inflated balloon centers the fiber and occludes the blood flow; 2, balloon angioplasty immediately following laser angioplasty; or 3, laser energy transmitted through angioplasty balloons that contain an internal fiber.

Treatment using irradiation with LASER light of low power intensity so that the effects are not due to heat, as in LASER THERAPY. These non-thermal effects are thought to be mediated by a photochemical reaction that alters CELL MEMBRANE PERMEABILITY, leading to increased mRNA synthesis and CELL PROLIFERATION. Low-level laser therapy has been used for a wide variety of conditions, but most frequently for wound healing and pain control.

A light microscopic technique in which only a small spot is illuminated and observed at a time. An image is constructed through point-by-point scanning of the field in this manner. Light sources may be conventional or laser, and fluorescence or transmitted observations are possible.

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