A Randomized Intervention, Multi-Center Study to Determine the Role of Dexamethasone eye drops against proliferative retinopathy of prematurity
EU CTIS ID: 2023-505318-97-00
What this study is testing
The primary objective in this study is to examine whether preventative treatment with topical Dexamethasone treatment may reduce the proportion of infants who need conventional ROP treatment in comparison to Placebo arm.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 1) Ongoing ocular infection
- 2) If the patient is judged unsuitable for the study by treating neonatologist/paediatrician or ophthalmologist for any other reason
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.