Retinopathy of Prematurity MedDRA version: 20.1 Level: LLT Classification code 10036858 Term: Proliferative retinopathy System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Dexafree
Product Name: Dexafree
Pharmaceutical Form: Eye drops
Pharmaceutical form of the placebo: Eye drops
Route of administration of the placebo: Ocular use
Sponsors
Region Västra Götaland, Sahlgrenska Universitetssjukhuset
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) preterm infants born =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Ocular infection 2) If the patient is judged unsuitable for the study by treating neonatologist/paediatrician or ophthalmologist for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduce frequency of ROP needing treatment;Secondary Objective: -Improve visual outcome at 2.5 and 5 years -reduce frequency of refractive errors -improve retinal morphology;Primary end point(s): 1) Reduced frequency of infants treated with laser and/or AntiVEGF for Type 1 ROP ;Timepoint(s) of evaluation of this end point: 1) around 40 weeks gesttational age (after finalised ROP screening) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2) Improved visual outcome at 2.5 and 5 years 3) Reduced frequency of refractive errors 4) Improved retinal morphological oucome at 1 year of age;Timepoint(s) of evaluation of this end point: 2) 2.5 and 5 years 3) 2.5 and 5 years 4) 1 year | — |
Countries
Sweden
Contacts
Public ContactCarola Pfeiffer Mosesson
The Sahlgrenska Center for Pediatric Ophthalmology Research
Outcome results
None listed