A clinical trial to compare effect of Injection Ranibizumab 0.25 mg versus Injection Aflibercept 1mg in infants of Retinopathy of Prematurity.

To compare effect of Inj ranibizumab0.25mg versus inj Aflibercept 1mg in Retinopathy of Prematurity. - Ranibizumab versus aflibercept in ROP

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054362

Enrollment

Registered

2023-06-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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: Injection RANIBIZUMAB 0.25 mg: Intravitreal Inj RANIBIZUMAB 0.25 mg in Retinopathy of prematurity in newborns for up to 45 weeks of preconceptional age Control Intervention1: Inj AFLIBE

Eligibility

Inclusion criteria

Inclusion criteria: Premature newborns of APROP (aggressive posterior rop) and Hybrid ROP which is presence of ridge tissue, characteristic of staged ROP along with flat neovascular syncytium, and character of APROP in same eye.

Exclusion criteria

Exclusion criteria: Patients with stage 4 and stage 5 ROP Patients with pre existing ocular disease like congenital cataract, congenital glaucoma and other retinopathy

Design outcomes

Primary

Measure	Time frame
Regression of ROP in-terms of change in percentage of vascularised retinaTimepoint: 4 weeks	—

Secondary

Measure	Time frame
Requirement of re injection Recurrence after injection Time duration before re injectionTimepoint: 4 weeks	—

Countries

India

Contacts

Public ContactLt Col Pradeep Kumar

Army Hospital Referral and Research

eyepradeep@yahoo.com9560034515

Outcome results

None listed

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