FindTrial
Sign In

To Evaluate Whether a Repeat Injection of Ranibizumab at 6 Weeks can Reduce the Rate of Disease Reactivation in Aggressive Retinopathy of Prematurity (AROP)

Role of Repeat Injection Ranibizumab in Management of Aggressive Retinopathy of Prematurity (AROP) in Preterm Neonates: Randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044475
Enrollment
20
Registered
2022-07-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Conditions

Health Condition 1: - Health Condition 2: H351- Retinopathy of prematurity

Interventions

Intervention1: Injection Ranibizumab: Repeat injection of Ranibizumab is given once, 6 weeks after the first injection of Ranibizumab (0.25mg in 0.025mL), at a dose of 0.25mg in 0.025mL by the intravi

Sponsors

Janani Shishu Suraksha Karyakram
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Gestational age 2. Birth weight 3. Bilateral Zone 1 or Zone 2 Posterior AROP 4. No previous treatment 5. Clear media suitable for documentation and treatment 6. Pediatrician assesses the neonate to be fit enough for the procedure

Exclusion criteria

Exclusion criteria: 1. Reactivation before 6 weeks after first dose of Ranibizumab 2. Parents unwilling for consent 3. Parents not willing for regular and complete follow up

Design outcomes

Primary

MeasureTime frame
To compare the disease regression in neonates with aggressive ROP treated with a single injection of Ranibizumab vs repeat injection of Ranibizumab at 6 weeks after the first injectionTimepoint: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks, 16 weeks, 18 weeks, 20 weeks.—

Secondary

MeasureTime frame
To compare following outcomes: 1. Extent of vascular regrowth 2. Need for additional treatment 3. Procedure-related systemic morbidity 4. Changes in refractive errorTimepoint: 2 weekly, till 20 weeks—

Countries

India

Contacts

Public ContactDr Aiswarya Sasi

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

parijatchandra@gmail.com9810019977

Outcome results

None listed

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