Comparison of Razumab and Accentrix in infants with aggressive retinopathy of prematurity (A-ROP)

Efficacy and reactivation rates between biosimilar and innovator Ranibizumab in aggressive retinopathy of prematurity prospective multicenter cohort study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083061

Enrollment

100

Registered

2025-03-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H351- Retinopathy of prematurity

Interventions

Intervention1: Innovator Ranibizumab (Accentrix®, Novartis India): Intravitreal injection of Ranibizumab 0.25 mg/0.025 ml x Single administration. The drug will will be administered in vitreous cavity

Eligibility

Inclusion criteria

Inclusion criteria: Infants diagnosed with Aggressive- Retinopathy of prematurity (A-ROP) as per International classification of ROP-3 (ICROP 3) guidelines will be included.

Exclusion criteria

Exclusion criteria: 1. Infants diagnosed with Hybrid Disease or other forms of ROP will be excluded. 2. Infants with congenital nasolacrimal duct obstruction in any of the eye

Design outcomes

Primary

Measure	Time frame
To compare the proportion of infants achieving primary success between Innovator Ranibizumab and Biosimilar Ranibizumab groups Primary success: Regression of plus disease or flat new vessels at or within 1 week of initial intravitreal injection of either drug Primary treatment failure: Persistent plus disease or flat new vessels at 1 weeks following initial intravitreal injection of either of the drug Timepoint: 1 week	—

Measure

Time frame

To compare the proportion of infants achieving primary success between Innovator Ranibizumab and Biosimilar Ranibizumab groups Primary success: Regression of plus disease or flat new vessels at or within 1 week of initial intravitreal injection of either drug Primary treatment failure: Persistent plus disease or flat new vessels at 1 weeks following initial intravitreal injection of either of the drug Timepoint: 1 week

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Secondary

Measure	Time frame
Comparison of the incidence, the reactivation interval & type of reactivation between Innovator Ranibizumab & Biosimilar Ranibizumab groupsTimepoint: 12 weeks;To compare the incidence & types of post injection complications/ adverse events & structural outcomes at final follow up between Innovator Ranibizumab & Biosimilar Ranibizumab groupsTimepoint: At final follow up or at 24 weeks after the initial intervention.	—

Measure

Time frame

Comparison of the incidence, the reactivation interval & type of reactivation between Innovator Ranibizumab & Biosimilar Ranibizumab groupsTimepoint: 12 weeks;To compare the incidence & types of post injection complications/ adverse events & structural outcomes at final follow up between Innovator Ranibizumab & Biosimilar Ranibizumab groupsTimepoint: At final follow up or at 24 weeks after the initial intervention.

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Countries

India

Contacts

Public ContactAnil Babanrao Gangwe

MGM Eye Institute, Raipur

anil@mgmeye.org7746058332

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026