Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

Retinopathy of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04191954
• Other study ID #: 9800
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 2, 2019
• Est. completion date: September 2020

Study information

• Verified date: November 2019
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Alireza Ramezani, MD
• Phone: 009822591616
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: September 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 45 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• Fasudil eye drops (concentration 0.5 percent)
receive Fasudil eye drops (concentration 0.5 percent) twice daily
• receive artificial tears drop
receive artificial tears drop with the same frequency

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stimulation of normal retinal vascularization and disease progression inhibition	Fundoscopy and examiner judgment which will be documented by retinal camera	3 months
Secondary	Any adverse event	Neonatologist and ophthalmologist examination	3 months