Can steroid eyedrops prevent severe ROP
Phase 1
- Conditions
- Retinopathy of PrematurityMedDRA version: 20.1Level: LLTClassification code 10036858Term: Proliferative retinopathySystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2020-004933-19-SE
- Lead Sponsor
- Region Västra Götaland, Sahlgrenska Universitetssjukhuset
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
1) preterm infants born <30 weeks of gestation
2) ROP zone I without plus disease with either
a. stage 1 or b. stage 2 or
3) ROP posterior zone II without plus disease with either
a.Posterior ROP stage 2
or
b. ROP stage 3 with or without notch in zone I
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
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
1) Ocular infection
2) If the patient is judged unsuitable for the study by treating neonatologist/paediatrician or ophthalmologist for any other reason
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Reduce frequency of ROP needing treatment;Secondary Objective: -Improve visual outcome at 2.5 and 5 years<br>-reduce frequency of refractive errors<br>-improve retinal morphology;Primary end point(s): 1) Reduced frequency of infants treated with laser and/or AntiVEGF for Type 1 ROP<br>;Timepoint(s) of evaluation of this end point: 1) around 40 weeks gesttational age (after finalised ROP screening)<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 2) Improved visual outcome at 2.5 and 5 years<br>3) Reduced frequency of refractive errors<br>4) Improved retinal morphological oucome at 1 year of age;Timepoint(s) of evaluation of this end point: 2) 2.5 and 5 years<br>3) 2.5 and 5 years<br>4) 1 year