Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Retinopathy of Prematurity

Treatments: Drug: receive artificial tears drop; Drug: Fasudil eye drops (concentration 0.5 percent)

Study type: Interventional

Funder types: Other

Identifiers

NCT04191954

9800

Details and patient eligibility

About

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.

Enrollment: 184 estimated patients

Sex: All

Ages: Under 45 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 2 patient groups, including a placebo group

Fasudil eye drops (concentration 0.5 percent)

Active Comparator group

Description:

twice daily

Treatment:

Drug: Fasudil eye drops (concentration 0.5 percent)

receive artificial tears drop with the same frequency

Placebo Comparator group

Treatment:

Drug: receive artificial tears drop