Archives: Clinical Studies

BEAT ROP Trial: Bevacizumab (Avastin) vs Laser in ROP

Avastin (bevacizumab)BEAT ROP trial compares the effect of anti-VEGF drug Bevacizumab (Avastin) vs Laser in ROP. The full form of BEAT is Bevacizumab Eliminates the Angiogenic Threat of Retinopathy of Prematurity (BEAT-ROP).

This is a prospective, controlled, randomized, stratified, multicenter trial to assess intravitreal bevacizumab monotherapy for zone I or zone II posterior stage 3 with plus disease retinopathy of prematurity. Infants were randomly assigned to receive intravitreal bevacizumab (0.625 mg in 0.025 ml of solution) or conventional laser therapy, bilaterally. The primary ocular outcome was recurrence of retinopathy of prematurity in one or both eyes requiring retreatment before 54 weeks’ postmenstrual age.

They concluded that Intravitreal bevacizumab monotherapy, as compared with conventional laser therapy, in infants with stage 3+ retinopathy of prematurity showed a significant benefit for zone I but not zone II disease. Development of peripheral retinal vessels continued after treatment with intravitreal bevacizumab, but conventional laser therapy led to permanent destruction of the peripheral retina.

But the trial was too small to assess safety and the safety issues regarding Avastin in ROP still persist.

HOPE Study: High Oxygen Percentage in ROP

Retinopathy of prematurity outcome in infants with prethreshold retinopathy of prematurity and oxygen saturation >94% in room air: the high oxygen percentage in retinopathy of prematurity study aimed to determine the rate of progression from prethreshold to threshold retinopathy of prematurity (ROP) in infants excluded from Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP) because their median arterial oxygen saturation by pulse oximetry (SpO2) values were >94% in room air at the time of prethreshold diagnosis and to compare them with infants who were enrolled in STOP-ROP and had median SpO2 < or =94% in room air.

They concluded that the mechanisms that result in better ROP outcome for HOPE-ROP versus STOP-ROP are not fully understood. It seems that an infant's SpO2 value at the time of prethreshold diagnosis is a prognostic indicator for which infants may progress to severe ROP. When other known prognostic indicators are factored in, the SpO2 is of borderline significance.

Source: McGregor ML, Bremer DL, Cole C, McClead RE, Phelps DL, Fellows RR, Oden N; HOPE-ROP Multicenter Group. High Oxygen Percentage in Retinopathy of Prematurity study. Retinopathy of prematurity outcome in infants with prethreshold retinopathy of prematurity and oxygen saturation >94% in room air: the high oxygen percentage in retinopathy of prematurity study. Pediatrics. 2002 Sep;110(3):540-4.

STOP Trial: Supplemental Oxygen for ROP Treatment

Supplemental oxygen for the treatment of prethreshold retinopathy of prematurity (STOP) trial was done to determine whether, in preterm or low birth weight infants with prethreshold ROP, targeting higher as compared to normal transcutaneous oxygen levels or pulse oximetry levels when using supplemental oxygen reduces the progression of ROP to threshold disease and improves visual outcome without any adverse effects.

The results of this STOP trial do not show a statistically significant reduction in the rate of progression to threshold ROP with supplemental oxygen treatment, but reveal increased adverse pulmonary sequelae with higher oxygen targeting in this group of preterm infants.

Source: Lloyd J, Askie L, Smith J, Tarnow-Mordi W. Supplemental oxygen for the treatment of prethreshold retinopathy of prematurity. Cochrane Database Syst Rev. 2003;(2):CD003482. Review.

ETROP Trial: Early Treatment for ROP

The Early Treatment for Retinopathy of Prematurity (ETROP) study, funded by the National Eye Institute, has shown that early treatment of high-risk prethreshold retinopathy of prematurity (ROP) improves retinal and visual outcomes at 9 months corrected age. These favorable study results have yielded new guidelines for treatment of infants with ROP. See Type I ROP and Type 2 ROP.

Good WV; Early Treatment for Retinopathy of Prematurity Cooperative Group. Final results of the Early Treatment for Retinopathy of Prematurity (ETROP) randomized trial. Trans Am Ophthalmol Soc. 2004;102:233-48; discussion 248-50.