Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

• Status: Unknown status
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shahid Beheshti University of Medical Sciences
• Treatments: 1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine; Fasudil; Lubricant Eye Drops; Ophthalmic Solutions

Criteria

Inclusion Criteria:

• Premature infants who are candidate for retinopathy of prematurity (ROP) screening with ROP Type 2

Exclusion Criteria:

• Serious systemic problems

• Other ocular problems Except ROP