Median Time to ROP Regression Faster with Ranibizumab Compared to Laser

James D. Reynolds, MD

A post-hoc analysis of the RAINBOW trial revealed intravitreal ranibizumab induced faster retinopathy of prematurity (ROP) regression in the treatment of infants compared to laser therapy.

The data show intravitreal 0.2 or 0.1 mg ranibizumab induced a faster regression of plus disease, stage 3 ROP, and AP-ROP compared to laser.

“Raniziumab was associated with fewer additional treatments for incomplete disease regression but more for disease reactivation,” wrote study author James D. Reynolds, MD, UBMD Ophthalmology at the Ross Eye Institute, on behalf of the RAINBOW Investigator Group.

Reynolds and colleagues aimed to study the time course of ROP regression and reactivation after intravitreal ranibizumab or laser in the Ranibizumab versus laser therapy for the treatment of very low birthweight infants with ROP (RAINBOW) trial.

This analysis included a total of 225 infants, or 448 eyes. They were randomized to ranibizumab 0.2 mg (n = 74, 148 eyes), ranibizumab 0.1 mg (n = 77, 152 eyes), and laser (n = 74, 148 eyes).

Investigators measured features of disease regression using time-to-event analysis per eye, corrected for within-subject association. Moreover, analyses of disease reactivation and additional treatments were descriptive.

The main study outcomes were median time to regression of plus disease, stage 3 ROP, aggressive posterior-ROP to 24-week follow-up and disease reactivation and first additional treatment to 2-year follow-up.

Data show the median times to regression after ranibizumab 0.2 mg versus laser were as follows:

• Plus disease, 4 vs 16 days (P <.001)
• Stage 3 ROP, 8 vs 16 days (P = .004)
• AP-ROP, 7.3 vs 22 days (P = .03)

Moreover, the findings for ranibizumab 0,1 mg were similar to patients with 0.2 mg, with a median of 4, 9, and 8 days, respectively. Investigators reported additional treatments were given in 34 (25%) of 138 eyes after laser and 40 (27%) of 146 and 42 (28%) of 152 eyes after 0.2 mg and 0.1 mg ranibizumab, respectively.

They further observed that incomplete disease regression requiring additional treatment occurred in 30 (22%) of 138 eyes after laser, after a median interval of 15 days. This was compared with 11 (8%) of 146 and 9 (6%) of 152 after 0.2 mg and 0.1 mg ranibizumab after a median interval of 21 and 13 days, respectively.

Moreover, ROP reactivation requiring additional treatment occurred in 3 (2%) of 138 eyes after laser after a median interval of 43 days. In comparison, ROP reactivation occurred in 22 (15%) of 146 and 26 (17%) of 152 after 0.2 and 0.1 mg ranibizumab after a median interval of 53.5 and 54.5 days, respectively.

The study, “Time Course of Retinopathy of Prematurity Regression and Reactivation After Treatment with Ranibizumab or Laser in the RAINBOW Trial,” was published in Ophthalmology Retina.