Emory Eye Center will participate in a Phase I research study to establish a safety profile for an anti-VEGF (vascular endothelial growth factor) drug, Avastin (Bevacizumab), for premature babies with retinopathy of prematurity (ROP).
Babies with aggressive posterior ROP who have failed appropriate laser treatment and demonstrate persistent, worsening or recurrent vascular activity can be enrolled. Babies must be at least 30 weeks postmenstrual age (PMA) and no greater than 36 weeks PMA.
Postmenstrual age is the time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (chronological age). Postmenstrual age is usually described in number of weeks and is most frequently applied during the perinatal period beginning after the day of birth.
One eye will be randomly selected for anti-VEGF treatment and the fellow eye will serve as the control eye [one that does not receive treatment]. The anti-VEGF drug Avastin will be given as a one-time intravitreal injection. The target enrollment is 22 infants from 11 sites with no more than three infants from any one site.
Emory Eye Center will participate with 10 other sites across the U.S. G. Baker Hubbard III, MD, associate professor of ophthalmology, and director, clinical retina service of Emory Eye Center, will serve as Emory's physician investigator for the PAN-VEGF Blockade for the Treatment of ROP (Block-ROP).
"Bevacizumab is an exciting new drug that may benefit infants with ROP, and we are pleased to be able to systematically study the drug with other clinical investigators around the country," says Hubbard. "Safety is our number one concern, however, because we already have an effective treatment for most cases of ROP in laser photocoagulation. That is why, in this first phase of the study, we are investigating the effects of the drug only in the most severe cases that have already failed laser."
Retinopathy of prematurity (ROP) is a leading cause of childhood blindness in the U.S. and the developed world. The condition typically affects children born at less than 32 weeks gestation and weighing less than 1500 grams at birth. Many cases are mild and improve without specific treatment as the child grows and develops. Some cases, however, are severe and result in retinal scarring, retinal detachment, and blindness.
For severe cases, laser treatment can reduce scar tissue formation, reduce retinal detachment risk and reduce the chance of blindness. Despite being the most effective treatment available, however, laser treatment has significant disadvantages and better treatment options are needed. In addition, for the most aggressive form of ROP - aggressive posterior ROP (APROP), laser is often not effective.
The Block-ROP Trial aims to evaluate intravitreal injection of Avastin in infants with ROP. There will be two phases in this study -- Phase I will be to establish a safety profile (Block-ROP, Group 1) and Phase II will be to demonstrate/confirm efficacy of Avastin in reducing incidence of retinal detachment (Group 2).
The phase 1, BLOCK-ROP study currently is enrolling patients at the Emory Eye Center/ Children's Healthcare of Atlanta.
About Emory Eye Center
The Department of Ophthalmology and Emory Eye Center have a mission to conduct pioneering research into blinding eye diseases, to educate and train eye professionals, and to provide excellent patient care. The Department includes 23 ophthalmologists, seven optometrists, nine basic scientists, 11 post-doctoral fellows, and nine researchers in other Emory departments who hold joint appointments in the Department of Ophthalmology. Ophthalmology research is supported by $6 million in NIH funding. The Department has remained in the top rankings by U.S. News & World Report for the 11 years the magazine has held a ranking for Ophthalmology. For more information visit http://eyecenter.emory.edu