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To Compare Two Different Eye Injections for Premature Babies with Retinal Problem

Comparison of Intravitreal Ranibizumab Versus Aflibercept for Treatment of Retinopathy of Prematurity- A Pilot Randomized Clinical Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092489
Enrollment
20
Registered
2025-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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: Aflibercept Injection: Intravitreal injection of Aflibercept in type 1 ROP- Dose- 0.4mg/0.01ml, Frequency- Once, Route- Intravitreal injection, Follow-up- Till 20 weeks after injectio

Sponsors

Janani Shishu Suraksha Karyakram
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Zone 1 or zone 2 posterior Type 1 Retinopathy of prematurity (ROP) including aggressive ROP 2. Bilaterally symmetrical disease 3. Treatment naive cases 4. Signed informed consent from parent/ guardian

Exclusion criteria

Exclusion criteria: 1. Type 2 ROP 2. Zone 2 anterior or zone 3 disease 3. Stage 4 or 5 disease 4. Corneal or lenticular opacities or vitreous haemorrhage obscuring assessment 5. Pediatric conditions rendering the infant ineligible for intervention 6. Active ocular infection rendering the infant ineligible for intervention 7. Parents not willing or giving consent

Design outcomes

Primary

MeasureTime frame
Proportion of eyes developing reactivation of disease following intravitreal ranibizumab versus aflibercept injection in zone 1 or zone 2 posterior type 1 ROPTimepoint: 20 weeks post injection—

Secondary

MeasureTime frame
Time to reactivation following injectionTimepoint: Till 20 weeks post injection;Type of reactivation following injectionTimepoint: Till 20 weeks post injection;Time to regression of acute phase ROP following injectionTimepoint: Till 20 weeks post injection;Extent of vascularisation at the time of reactivationTimepoint: Till 20 weeks post injection;Extent of vascularisation at final visitTimepoint: 20 weeks post injection;Need for additional treatmentTimepoint: Till 20 weeks post injection;Refractive error at last visitTimepoint: 20 weeks post injection;Anatomical outcome at last visitTimepoint: 20 weeks post injection—

Countries

India

Contacts

Public ContactDr Devesh Kumawat

Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi

abhaygoku.00753@gmail.com9560745150

Outcome results

None listed

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