Low-dose ranibizumab in the treatment of AROP [aggressive retinopathy of prematurity]

Design: Hospital-based randomized clinical trial (academic trial). Purpose: Efficacy of two Ranibizumab doses (0.125 mg/0.25 mg) in the treatment of aggressive retinopathy of prematurity (AROP). Method: Seventy-four babies were randomized for low dose [LD] and conventional dose [CD] of intravitreal Ranibizumab for ZONE-1 AROP and ZONE-2 posterior AROP, and followed up over 6 months. Results: Thirty-six AROP were allotted in LD [1 lost to F/U] and 35 in CD [1 lost to F/U and one died]. LD applied to 21 infant’s B/E and 15 infant’s S/E [total 57 eyes]. CD was given to 19 infants in B/E and 16 infants in S/E [total 54 eyes]. Both ZONE-1 AROP and ZONE-2 posterior AROP are present in the above two groups. In the CD, 50% of infants had recurrence of AROP, whereas the figure is only 28.07% in infants who were instilled with low-dose Ranibizumab. The rate of complete vascularization is significantly higher in the LD group, i.e., 56.14% in comparison to the CD group, where only 18.51% had complete vascularization. The rate of incomplete vascularization is also 1.6 times higher in the CD than in the LD group. Clinical Impact: Although the current consensus in India for treating AROP is a combination of LD or CD dose of anti-VEGF (vascular endothelial growth factor) with laser, LD anti-VEGF alone has proven more promising in terms of both complete vascularization and reduced recurrence rates. It is also cost-effective with a favorable risk-to-benefit ratio.