Evaluating Treatment Outcomes of Intravitreal Aflibercept in Retinopathy of Prematurity
Abstract
AbstractObjective: To evaluate the anatomical treatment outcomes of intravitreal aflibercept in infants with severe Stage 3 ROP.
Methods: This prospective cohort study was conducted at Tertiary care Eye Hospital from August 1, 2025, to January 31, 2026. Sixteen infants (32 eyes) with gestational age <34 weeks and birth weight <2000 g who had treatment-requiring Stage 3 ROP received intravitreal aflibercept [0.4 mg/0.01 mL]. Outcomes were assessed at 1–2 weeks, 4–6 weeks, and 3 months. Continuous variables were summarized as mean ± SD and categorical variables as frequencies and percentages. Descriptive statistics were used; exploratory comparisons were performed due to small sample size. Because of the small sample and low number of unfavorable outcomes, regression analyses were considered exploratory.
Results: At 3 months, complete regression was achieved in 26 eyes (81.3%), partial regression in 4 eyes (12.5%), and no change in 2 eyes (6.2%). No eye showed disease progression or recurrence during follow-up. Two eyes (6.2%) belonging to one infant required rescue laser photocoagulation. Mild subconjunctival hemorrhage occurred in 4 eyes (12.5%); no major ocular or systemic adverse events were observed. Lower gestational age, lower birth weight, Zone I disease, and aggressive ROP were associated with unfavorable outcomes on exploratory analysis.
Conclusion: Intravitreal aflibercept appears to be a safe and effective option for the initial management of severe Stage 3 ROP, with high anatomical regression and few short-term complications. Larger studies with longer follow-up are needed to confirm long-term ocular and systemic safety.
Keywords:
AbstractObjective: To evaluate the anatomical treatment outcomes of intravitreal aflibercept in infants with severe Stage 3 ROP.
Methods: This prospective cohort study was conducted at Tertiary care Eye Hospital from August 1, 2025, to January 31, 2026. Sixteen infants (32 eyes) with gestational age <34 weeks and birth weight <2000 g who had treatment-requiring Stage 3 ROP received intravitreal aflibercept [0.4 mg/0.01 mL]. Outcomes were assessed at 1–2 weeks, 4–6 weeks, and 3 months. Continuous variables were summarized as mean ± SD and categorical variables as frequencies and percentages. Descriptive statistics were used; exploratory comparisons were performed due to small sample size. Because of the small sample and low number of unfavorable outcomes, regression analyses were considered exploratory.
Results: At 3 months, complete regression was achieved in 26 eyes (81.3%), partial regression in 4 eyes (12.5%), and no change in 2 eyes (6.2%). No eye showed disease progression or recurrence during follow-up. Two eyes (6.2%) belonging to one infant required rescue laser photocoagulation. Mild subconjunctival hemorrhage occurred in 4 eyes (12.5%); no major ocular or systemic adverse events were observed. Lower gestational age, lower birth weight, Zone I disease, and aggressive ROP were associated with unfavorable outcomes on exploratory analysis.
Conclusion: Intravitreal aflibercept appears to be a safe and effective option for the initial management of severe Stage 3 ROP, with high anatomical regression and few short-term complications. Larger studies with longer follow-up are needed to confirm long-term ocular and systemic safety.
Keywords: Retinopathy of prematurity; Stage 3 ROP; Aggressive ROP; Intravitreal; Aflibercept.
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