drugset / Trial / NCT04191954

Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

NCT04191954

Phase 2/3 Unknown 184 enrolled Shahid Beheshti University of Medical Sciences
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

EvaluationDrugModalityDoseRoute
Comparator Fasudil Small molecule 0.5 % Topical