A Randomized Intervention, Multi-Center Study to Determine the Role of Dexamethasone eye drops against proliferative retinopathy of prematurity
Phase 1
Recruiting
- Conditions
- Retinopathy of PrematurityMedDRA version: 20.1Level: LLTClassification code: 10036858Term: Proliferative retinopathy Class: 10015919Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- CTIS2023-505318-97-00
- Lead Sponsor
- Vaestra Goetalandsregionen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1)Gestational age <30 weeks, 2)Zone I ROP without plus disease with either a. ROP Stage 1, or ROP Stage 2 or Zone II ROP without plus disease with either a.Posterior ROP stage 2 or b. ROP stage 3 with or without notch in zone I, 3)ROP stage documented using RetCam photography and confirmed by two ophthalmologists, 4)Parent’s informed (oral and written information) consent.
Exclusion Criteria
1)Ongoing 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
- Secondary Outcome Measures
Name Time Method