Health Condition 1: H351- Retinopathy of prematurity
Conditions
Interventions
Intervention1: Ranibizumab: Dose-0.25mg in 0.025ml
Frequency- Once
Route of administration- Intravitreal injection
Duration of therapy-Single dose
Control Intervention1: Laser: Dose-Depends on area af
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: -Gestational age -Birth weight -Zone 2 stage 2-3 ROP with plus in both eyes (Type 1 ROP) -Clear media suitable for documentation and treatment -Child systemically stable and fit for treatment
Exclusion criteria
Exclusion criteria: -Zone 1 and zone 3 ROP -APROP -Type 2 ROP -Stage 4 or 5 ROP -Previous laser/injections/surgery or any other eye surgery -Parents unwilling for consent -Parents not willing for regular and complete follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease regression after treatmentTimepoint: Baseline,1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 20 weeks and 24 weeks post procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| -Changes in Refractive error -Occurrence of Vascular regrowth -Incidence of Recurrence warranting rescue -Post procedure systemic morbidityTimepoint: Baseline,1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 20 weeks and 24 weeks post procedure | — |
Countries
India
Contacts
Public ContactDr Arpita Kulshrestha
AIIMS, Delhi
Outcome results
None listed