drugset / Trial / NCT04191954
Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)
RandomizedParallel-groupDouble-blindTreatment
Summary
Eligible eyes are randomly assigned into two groups. Group A receive Fasudil eye drops (concentration 0.5 percent) twice daily. Group B, receive artificial tears drop with the same frequency. Retinal specialists who are expert in Retinopathy Of Prematurity field will perform fundus examination regularly. The examiners are blind. The progression of normal retinal vascularization and need to treatment will be documented and compared between the two study groups. The topical eye drops are used until the retinal vascularization are complete (45 week after LMP) or the patient needs to be treated.
Timeline
- Start
- 2019-06-02
- Primary completion
- 2019-11-01
- Completion
- 2020-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fasudil | Small molecule | 0.5 % | Topical |