AP-ROP MedDRA version: 9.1 Level: LLT Classification code 10038933 Term: Retinopathy of prematurity
Conditions
Interventions
Trade Name: AVASTIN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Bevacizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: preterm newborns EG less or equal to 29 weeks and/or birth weigth less or equal to mg with AP-ROP Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Congenital malformation or different ROP staging between the to eyes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of our study is to verify the effectiveness of intravitreal injection of Bevacizumab vs. laser surgery in the treatment of AP-ROP of very preterm infants.;Secondary Objective: nd;Primary end point(s): to verify the efficacy of Bevacizumab in reducing evolution of retinal neovascolaritation and in improving severe ROP prognosis by indirect ophthalmoscopy and RETCam imaging | — |
Countries
Italy
Outcome results
None listed