Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Injection ranibizumab: Dose is 0.25 MG in 0.025 ML and is given by intravitreal injection route. One time injection is given to patients.
Control Intervention1: Laser: Laser treatment
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gestational Age less than 34 weeks 2. Birth weight less than 2000 grams 3. Bigger babies 34-36 weeks or more than 2kg if high risk for developing ROP 4. Threshold ROP - Zone 2 Stage 3 ROP (5 Contiguous / 8 non contiguous clock hours) with plus disease 5. No previous ROP treatment
Exclusion criteria
Exclusion criteria: 1. Zone I and Zone III disease 2. Zone 2 disease less than threshold criteria 3. Advanced stage disease (stage 4/ 5 ROP) 4. Any other ocular abnormality 5. Systemically unfit for procedure 6. Parents not providing consent for study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We assess for disease regression, progression or reactivation, extent of vascularization. We also assess the need for secondary intervention. We then compare these outcomes between groups which received primary intravitreal Ranibizumab vs laser in treatment of zone 2 threshold Retinopathy of Prematurity. Timepoint: Follow up will be done at 1 week and then 2 weekly till 50 weeks PMA or complete disease regression | — |
Secondary
| Measure | Time frame |
|---|---|
| a- To study need for additional treatment in both groups b- To study the extent of revascularization, reactivation, PAR requiring treatmentTimepoint: At 1 week & then 2 weekly till 50 weeks PMA or complete disease regression | — |
Countries
India
Contacts
Public ContactDr Iekshiytha K
AIIMS New Delhi
Outcome results
None listed