Clinical Trial: Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP)

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP)

Brief Summary: The purpose of this study is to determine whether a single intravitreal (into the gel of the eye) injection of Avastin 0.625mg or 0.75mg is equivalent (non-inferior) to treatment with standard of care laser in infants with Type I pre-threshold retinopathy of prematurity (ROP) diagnosed at 30-36 weeks gestational age.

Detailed Summary:

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 grow 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 multi-center 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 amendable 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 sick neonates. In this subset of infants, progression of ROP to retinal detachments in both eyes and even blindness may occur despite timely and complete peripheral retinal laser ablation.

RATIONALE:

The development of ROP is largely dependant on vascular endothelial growth factor (VEGF). When an infant is born prematurely, the relatively hyperoxic environment that the baby is introduced to shuts down the production of VEGF. Retinal maturation is thus delayed. Subsequently, at a time w
Sponsor: Vision Research Foundation

Current Primary Outcome: To demonstrate non-inferiority of Anti-VEGF treatment to standard-of-care laser [ Time Frame: With patient #58, 116 and 174 (within 3 months after each patient being enrolled) ]

It is the intent of this clinical study to develop alternative therapy (a single bevacizumab injection) to standard therapy (laser ablation) and to show that bevacizumab is as safe and efficacious as laser.


Original Primary Outcome: Same as current

Current Secondary Outcome: Decreased laser ablation and improved vascular maturity [ Time Frame: With patient #58, 116 & 174 (within 3 months after each patient being enrolled) ]

These 2 end-points will be monitored by evidence of persistent disease and presence/absence of progression to retinal detachment. If either or both of these objectives are not met, it is indicative of failure of treatment.


Original Secondary Outcome: Same as current

Information By: Vision Research Foundation

Dates:
Date Received: October 26, 2010
Date Started: June 2012
Date Completion: July 2018
Last Updated: October 16, 2013
Last Verified: October 2013