drugset / Trial / NCT01238471
Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study
Phase 1/2
Completed
20 enrolled
Rambam Health Care Campus
Hadassah Medical Organization · collabLaniado Hospital · collabNazareth Hospital · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
In premature infants, propranolol (Prop) treatment might suppress continuing neo-vascularization (NV) and decelerate the progression of retinopathy of prematurity (ROP) towards its severe stages (III-V), thus avoiding the need of interventions (CRYO and/or LASER photo-coagulation of the ischemic retina and preventing severe ocular sequelae. We therefore plan to prospectively investigate the influence of prop versus placebo in VLBW infants with ROP stage 1 (zone I), with stage 2 or higher (any zone) or with Plus disease, along with close follow up regarding safety of prop administration and its effect on ROP.
Timeline
- Start
- 2010-05
- Primary completion
- 2012-05
- Completion
- 2012-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Propranolol | Small molecule | 2 mg/kg | Oral |