News Releases

October 23, 2008

Emory Eye Center to Participate in a Clinical Research Study to Investigate a Promising New Treatment for Retinopathy of Prematurity

Media contact:
Joy Bell, 404-778-3711

(ATLANTA) Emory Eye Center along with 10 other sites across the country 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. The babies must be at least 30 weeks post-menstrual age (PMA) and no greater than 36 weeks PMA. One eye will be randomly selected for anti-VEGF treatment and the fellow eye will serve as the control eye. 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 3 infants from any one site.

G. Baker Hubbard III, MD, associate professor of Ophthalmology, and director, Clinical Retina Service at 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 Dr. 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 United States 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 is currently ready to enroll patients at the Emory Eye Center/Children’s Healthcare of Atlanta.


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