Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

NCT04191954 | Unknown Phase 2

• 1 other identifier: 9800
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Stimulation of normal retinal vascularization and disease progression inhibition

  Fundoscopy and examiner judgment which will be documented by retinal camera

  3 months

Secondary Outcomes (1)

• Any adverse event

  3 months

Study Arms (2)

Fasudil eye drops (concentration 0.5 percent)

ACTIVE COMPARATOR

twice daily

Drug: Fasudil eye drops (concentration 0.5 percent)

receive artificial tears drop with the same frequency

PLACEBO COMPARATOR

Drug: receive artificial tears drop

Interventions

Fasudil eye drops (concentration 0.5 percent) DRUG

receive Fasudil eye drops (concentration 0.5 percent) twice daily

Fasudil eye drops (concentration 0.5 percent)

receive artificial tears drop DRUG

receive artificial tears drop with the same frequency

receive artificial tears drop with the same frequency

Eligibility Criteria

• Age: Up to 45 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Serious systemic problems
• Other ocular problems Except ROP

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Alireza Ramezani, MD

CONTACT

009822591616; labbafi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ophthalmic research center

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 10, 2019
• Study Start: June 2, 2019
• Primary Completion: November 1, 2019
• Study Completion: September 1, 2020
• Last Updated: December 10, 2019

Record last verified: 2019-11

Locations

IR (1)