NCT04191954

Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

Fasudil Eye Drop in Retinopathy Of Prematurity, Retinal Vascularization Induction and Disease Progression Inhibition, a Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 45 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
DRUG	Fasudil eye drops (concentration 0.5 percent)	receive Fasudil eye drops (concentration 0.5 percent) twice daily
DRUG	receive artificial tears drop	receive artificial tears drop with the same frequency

Timeline

• Start date: 2019-06-02
• Primary completion: 2019-11-01
• Completion: 2020-09-01
• First posted: 2019-12-10
• Last updated: 2019-12-10

Locations

1 site across 1 country: Iran